Outsourcing Biologics Fill Finish Manufacturing : Streamlining the Production Process for Biopharmaceutical Companies

Biologics fill finish represent one of the fastest growing segments of the pharmaceutical industry. Over the years, these large molecules have demonstrated promising therapeutic outcomes in the treatment of myriad of chronic and challenging disorders, including autoimmune disorders, infectious diseases, genetic disorders, and oncological disorders. These complex entities, such as antibodies, antibody drug conjugates, cell

Squamous Non Small Cell Lung Cancer Market: Current Scenario

Close to 1.8 million fatalities reported in 2020 were observed to be associated with lung cancer, which is believed to be one of the most aggressive forms of carcinoma, globally. One of the primary reasons for the high mortality rate associated with this condition is anticipated to be improper liquid biopsy, which eventually results in

Remote Patient Monitoring System: A Paradigm Shift in Healthcare

The development of the concept of remote patient monitoring system (RPM) started nearly 200 years ago in 1800s. However, it wasn’t until the introduction of cloud computing, that the domain evolved at a significant pace. In fact, remote patient monitoring system solutions are gradually being integrated into mainstream healthcare; specifically, during the COVID-19 induced lockdown,

Antiviral Medications: An Unmet Requirement in Pharmaceuticals

Over the past few years, a number of antiviral drugs targeting a myriad of infectious diseases, including human immunodeficiency virus (HIV) infection, hepatitis, herpes simplex virus (HSV) infection, cytomegalovirus (CMV) infection, influenza, coronavirus infection (COVID-19) and others, have received approvals from various regulatory authorities, globally. However, it is important to note that, currently, the approved

mRNA Technology: Transforming Medicine

Messenger ribonucleic acid (mRNA) serves as a carrier of genetic instructions from DNA to the cell machinery for the production of proteins. mRNA technology plays a significant role in the development of therapeutic interventions, exemplified by the incredible success of COVID-19 vaccines (namely COMIRNATY and Spikevax). It holds promise in treating various autoimmune disorders, degenerative

Anti-Counterfeiting Technologies in Healthcare

In order to effectively combat the problems related to counterfeit medicines, several companies have come up with innovative technologies to provide the necessary tools to manufacturers, healthcare professionals and patients to authenticate pharmaceutical products. Anti-counterfeiting technologies technologies can be broadly classified under two categories, namely Authentication Technologies and Track & Trace Technologies. Authentication technologies are

Zealand Pharma Stock Surge on Liver Disease Drug Trial Data

Shares of Zealand Pharma experienced a significant surge, jumping 16% as the market opened on Monday, following the release of groundbreaking phase II trial results for an experimental obesity treatment being developed in collaboration with Boehringer Ingelheim. This surge came as the trial testing the drug survodutide for the treatment of fatty liver, specifically metabolic

ADCs Pipeline Update: Sutro Biopharma Presents Encouraging Data in Patients with Advanced Ovarian Cancer

Sutro Biopharma, a California based, clinical-stage company, announced initial safety data in ovarian cancer patients from its ongoing phase I study (NCT03748186) of STRO-002. The drug is a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC) and potent anti-tumor activity in preclinical endometrial cancer patient-derived xenograft (PDX) models. Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused

Cell Therapy Pipeline Update: Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial

Cell Therapy pipeline update, Talaris Therapeutics, a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY, announced the initiation of FREEDOM-1 (NCT03995901), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients. What is the objective of the trial: This pivotal trial will evaluate the safety and efficacy of a

CARsgen anti-BCMA CAR T CellTherapy Receives RMAT Designation

On 28 October 2019, CARsgen Therapeutics, a clinical-stage biopharma company, announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. What is CT-053: CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple

Genome Editing Market Update: Intellia Therapeutics Presents Data at the 2019 Annual Congress of the European Society of Gene and Cell Therapy

Intellia Therapeutics, one of the leading genome editing company focused on the development of curative therapeutics using CRISPR/Cas9 technology is presenting one oral presentation and four poster presentations at the 27th Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) meeting taking place October 22-25, 2019, in Barcelona, Spain. The global genome

Unlocking the Potential of Digital Twins in Healthcare: Benefits, Challenges and Opportunities

The application of digital twins in healthcare has the potential to revolutionize patient care, improve clinical outcomes, and reduce costs. Digital twins, or virtual replicas of physical objects and environments, are being used in many different industries, and healthcare is no exception. In healthcare, these can be used to provide better patient monitoring, improve remote

Adeno-Associated Viral Vectors: Unlocking the Future Opportunities

Given the potential of gene therapies in targeting the underlying cause of a disease at cellular level,  the gene therapy market has increased considerably over the past few years. Currently, more than 285 gene therapies are being evaluated in different phases of clinical development. Further, various gene therapy developers have raised more than USD 10 billion capital

NFC Tags and RFID Smart Labels for Pharmaceutical and Healthcare Industry: Lets trace medicines from its origin

Traditionally, text and images were printed on pharmaceutical products to convey important information. In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. It is worth noting that smart labels contain a transponder code

Gene Therapy Pipeline Update: AGTC Presents Promising Data of its AAV Vectors for Ocular Gene Therapy

Applied Genetic Technologies Corporation (AGTC), a clinical-stage biotechnology company, developing transformational genetic therapies for patients suffering from rare and debilitating diseases, announced new data from non-clinical studies evaluating the effect of pre-existing anti-AAV antibodies on the transduction and expression efficiency of AAV vectors. Presently, over 250 companies are engaged in the gene therapy pipeline, the gene

Prescription Digital Therapeutics: Advancing Access to the Digital Pills

As per United Nation’s report, the current global population stands at around 8 billion and expected to reach 9 billion by the end of 2030. This increase in population is accompanied with a rise in the incidence of several chronic disease indications. In fact, as per a report published by National Association of Chronic Disease

Bioconjugation of Molecules: A Novel Advancement in Therapeutics

Bioconjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. These molecules can be conjugated with various modalities, such as haptens, enzymes, isotopes, fluorescent tags, carrier proteins, polymers, particle conjugates and photoreactive molecules. Bioconjugation is a subset of

Antibody Drug Conjugates Market Update: Ambrx and NovoCodex Collaborate

Ambrx and NovoCodex Biopharmaceuticals announced that they have formed a second collaboration to develop and commercialize Ambrx’s internally developed site-specific antibody drug conjugates. The antibody drug conjugates market is expected to grow at a CAGR of ~10% during the forecast period. What is the focus of the agreement: Under the agreement, Ambrx and NovoCodex will

Cybersecurity in Healthcare: A Must Have in Today’s Digital World

The healthcare industry has been amongst the prime targets for hackers over the last several years. In 2017, the healthcare industry had been compromised a number of times, representing 25% of the total number of breaches worldwide. Across these instances, around 31 million records were compromised, stolen or lost. In order to overcome these challenges,

Viral Vector Manufacturing: Current Landscape and Opportunities

Over the last few decades, various viral vector manufacturing have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. Currently, the most popular viral vectors, on the basis of their use in active clinical trials, are those based on AAV, adenovirus, lentivirus and retrovirus.

Myeloid Cell Targeting Therapies: Budding Therapy Against Cancer

The global cancer burden is increasing rapidly with over 19 million new cancer cases and 10 million deaths reported in the year 2020. Given the rising prevalence, researchers have made significant efforts in discovering new approaches for the treatment of oncological diseases using cell and gene therapy solutions. With several programs having entered the clinical

New Frontiers in Cancer Therapies: Focus on Transcription Factors, GTPases, Phosphatases and GPCRs, 2018-2030

Cancer Therapies continues to be one of the most active segments within the pharmaceutical industry. However, certain biological targets have long eluded drug development efforts. One such target is Ras family, which has been identified to play a critical role in oncogenesis. Scientific literature suggests that the RAS gene is mutated across about 30% of

Outsourcing Antibody Discovery Process: The Profit-Driven Approach to Research

Imagine a world where scientists work together to create special “soldiers” in our bodies called antibodies. These heroes help to fight diseases. Sometimes, scientists ask for help from experts who are really good at finding and designing these antibodies. These experts are like the superhero squad for medical research. They provide their antibody discovery services

Advanced Wound Care Products: The Novel Wound Care and Management Products

The rising prevalence of chronic diseases has resulted in rise in the associated co-morbidities, including wounds, mental health disorders, vascular disorders, sensory impairments, and others. Among these, the management of wounds has emerged as a critical aspect within the healthcare sector. Presently, more than 15 million individuals worldwide are suffering from various types of wounds,

Industrial and Medical Exoskeleton: Current Landscape and Future Market Outlook

Originally used in biology, the term exoskeleton refers to a chitinous or calcified external skeleton used by various animal taxa for structural support and defense against predators. Drawing from a similar concept, in the field of robotics, exoskeletons are wearable electromechanical devices that have been developed as augmentative devices to enhance the physical performance of

Cold Chain Packaging – Current Scenario and Future Potential

Cold chain is a three-fold concept, involving certain aspects that can be co-related to science, technology, and process development. In terms of science, cold chain industry requires the understanding of chemical and biological processes associated with the product. This technology usually relies on physical methods to ensure desirable temperature conditions for perishable products throughout the

Aesthetic Alchemy: “Artistry of Medical Aesthetic Procedures”

Medical Aesthetics is an area of modern medicine that specializes in improving the outer appearance of an individual without surgery. Medical aesthetic procedures can be broadly categorized into two categories, namely non-invasive and invasive. Medical aesthetic treatments that don’t require to puncture the skin and involve non-surgical devices are termed as non-invasive procedures whereas treatments

Revolutionizing Medicine and Public Health: The Emergence of Big Data in Healthcare

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Not only in healthcare, but various industries have also adopted big data to enhance their capabilities, improve customer experiences, and strengthen their brand reputation, thereby contributing to overall growth of

Discovering Relief: Exploring Sleep Apnea Medical Devices and Drug Therapies for Sleep Apnea Treatment

Sleep apnea (also known as sleep apnoea), is a sleep disorder characterized by interruptions in breathing during sleep. These interruptions in sleep, often caused by obstruction or reduced airflow, can result in reduced oxygen flow and last up to several minutes. Sleep apnea is often an underdiagnosed condition that can affect all age groups. According

Beyond Batch: The Transformative Force of Continuous Manufacturing

Continuous manufacturing process involves the production of pharmaceutical drug substance in a single run, while operating 24×7. In this process, the drug is developed from its base ingredients / raw materials and processed to the final product in one facility, without any hold time. For decades, pharmaceutical companies have manufactured drugs using batch processing in

Outsourcing Peptide Synthesis: Preferred Choice of Drug Developers

The peptide therapeutics market has undergone substantial evolution since the inception of insulin. It is worth mentioning that over the span of years, the pharmaceutical companies have shifted their focus from conventional interventions towards more advanced pharmacological strategies, such as peptide therapeutics. Presently, over 80 peptide-based drugs are available in the market for myriad of

Exploring the Miracle Antibody Drug Conjugate Technologies

With fourteen approved drugs and several drug candidates being evaluated under different stages of development, antibody drug conjugates (ADCs) are now recognized as a potent class of targeted therapeutics. The success of this relatively novel class of therapeutics is attributed to the ability of lead molecules to specifically identify and eliminate disease associated cells /

BridgeBio Pharma Secures $1.25 Billion to Propel Genetic Medicine Development

Introduction In a strategic move to accelerate the development and launch of genetic medicines, BridgeBio Pharma has successfully secured up to USD 1.25 billion from Blue Owl Capital and Canada Pension Plan Investment Board. The cornerstone of BridgeBio’s funding initiative involves a strategic agreement with Blue Owl Capital and Canada Pension Plan Investment Board. In

Chromatography Consumables and Chromatography Instrumentation Industry: Current Scenario and Future Trends

Chromatography finds several applications across different industries, including pharmaceutical, biotechnology, chemical, environmental, food, petrochemical, and other such industries. Specifically in pharmaceutical industry, recent years have witnessed a surge in the demand for chromatography systems / chromatography instrumentation (such as liquid chromatography system, gas chromatography system, gel permeation chromatography, supercritical fluid chromatography) and chromatography consumables (such

Plasma Fractionation: An Indispensable Component for Plasma-derived Therapies Manufacturing

Plasma fractionation, a critical process in the field of medical science, involves the separation of various components present in blood plasma to create valuable therapeutic products. This intricate procedure has gained significant recognition due to its ability to provide essential treatments and to address various medical indications. The success of plasma fractionation companies hinges upon

Eli Lilly’s Weight-Loss Drug, Mounjaro, Sparks an Epic Run in Pharma Shares

Introduction Over years, Eli Lilly has undergone a significant transformation, positioning itself as the world’s most valuable drugmaker. Renowned for psychiatric drugs such as Prozac, the company faced several challenges in revenue generation during the 2010s due to patent expiration of its innovative drugs. However, a strategic shift and a focus on innovative treatments have

Prefilled Syringes: Delivering Convenience and Precision in Every Dose

Prefilled syringes are syringes that come pre-filled with a specific dose of medication. They offer several advantages over traditional drug delivery systems (such as vials and syringes), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. It is worth highlighting that, prefilled syringes are preferably being used in the

Novartis Steps Back from Cytokinetics Acquisition Amid Stock Plunge

Introduction In a surprising turn of events, Swiss pharmaceutical giant Novartis has decided to step back from the pursuit of much-anticipated acquisition of Cytokinetics, a US based cardiovascular drug developer. This sudden decision has sent ripples through the market, prompting a significant drop in Cytokinetics’ stock value and leaving investors and industry analysts questioning the

Biologics Contract Manufacturing – Current Interest of the Pharmaceutical Industry

Biologics represent one of the fastest growing segments of the pharmaceutical industry. This canbe attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized pharmacological interventions. Although biopharmaceuticals offer significant profit margins and have demonstrated the potential to treat a myriad of disease indications, they are generally

Biologics – The Next Step in Revolutionary Medication

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Notably, biologics have higher success rates than conventional small-molecule drugs owing to lesser off-target toxicity of biologics, which

Medical Aesthetics: “Redefining Beauty through Medical Expertise”

In the pursuit of self-reinvention and confidence, medical aesthetics emerges as a powerful tool for reshaping not only the outer appearance of individuals but also their lives as well. Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. The idea of

The Promising Potential of Pulsed Field Ablation for Cardiac Rhythm Management

Heart disorders, which affect millions of lives worldwide, encompass a wide range of abnormalities related to the heart’s structure and function.  Amongst the various types of heart disorders, the prevalence of cardiac arrythmias has grown considerably. This condition manifests as heart beating too fast (tachycardia), too slow (bradycardia) or irregularly. These irregularities in the heart’s

A Deep Dive into Fine Grained Sentiment Analysis of Patient Engagement Solutions

Patient engagement refers to a strategic collaboration between patients and their treatment providers to offer all the relevant resources to patients in order to enable them to make appropriate decisions for their health. This approach allows patients to become well informed regarding the available treatment options, recovery, prescription choices or any other important medical solutions,

The Non Invasive Frontier: Liquid Biopsy Companies Refining Healthcare

Cancer has high mortality rate, primarily because of the delayed detection and complexities of current diagnostic procedures. The mortality rates associated with cancer can be significantly reduced if the efforts shift towards the development of methods for early detection of cancer. Amid the increasing burden of cancer and the limitations of traditional tissue biopsies, there

Virtual Clinical Trial Companies: Bringing Revolution in Medical Research

Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. In order to gain marketing approval from regulatory authorities for a novel therapeutic intervention, highly accurate and elaborate clinical trial data is required to validate

GalNAc Conjugates – Spearheading the Innovation for Conjugated Drugs

The next generation drug conjugate is relatively a new concept. This novel modality emerged when pharmaceutical developers used non-antibody-based entities as targeting ligand to develop targeted therapeutics. Similar to the structure of the antibody drug conjugates, these next generation drug conjugates use a non-antibody-based targeting ligand, a cytotoxic payload and a linker. However, the key

Chromatography Instrumentation and Chromatography Consumables: The Growing Role in Pharmaceutical Industry

Chromatography is an analytical technique, used for separation, identification and purification of the mixture of components. Chromatography Consumables and Chromatography Instrumentation are used in various industries, including pharmaceutical, biotechnology, chemical, environmental, food, and petrochemical industries, for multiple applications. Specifically in pharmaceutical industry, the demand for chromatography instrumentation and chromatography consumables (such as chromatography resin, packed

Healthcare Through Plasma Fractionation

Blood plasma, an invaluable component of human blood, stands as a cornerstone in the realm of modern healthcare and therapeutic interventions. In the plasma fractionation industry, plasma donation (which acts as the starting point for plasma fractionation), meticulous screening protocols, and judicious plasma fractionation processes are collectively utilized to develop life-saving plasma-derived therapies. These possibilities

ADC Conjugation – An Innovative Approach for Optimizing Targeted Delivery

Over the years, researchers and scientists have been on the lookout to find effective ways to treat various types of oncological disorders. This is because one of the approaches, such as chemotherapy, results in killing of both healthy and cancerous cells. Therefore, an innovative approach that can kill the targeted cell while minimizing toxicity was

Aya Healthcare’s Strategic Acquisition of Winnow AI: A Game-Changer in Healthcare Recruitment

Aya Healthcare strengthens its physician recruitment technology by acquiring Winnow AI, a move aimed at boosting its capabilities in the digital staffing sector. In a significant move poised to revolutionize healthcare recruitment, Aya Healthcare, a leading healthcare staffing and workforce solutions provider, has successfully acquired Winnow AI. The acquisition marks a strategic partnership between Aya

Novo Nordisk’s Pioneering Endeavor: Unraveling the Complexities of Obesity to Forge a Preventive Pathway

Novo Nordisk aims to employ insights from obesity drug research to proactively hinder the occurrence of weight gain. Introduction Novo Nordisk, the eminent Danish pharmaceutical giant, has embarked on a groundbreaking journey. While the demand for Novo Nordisk’s weight-loss and diabetes drugs has already propelled the company to the status of Europe’s largest, it now

Unveiling the Future: A Breakthrough Blood Test for Early Alzheimer’s Detection

Introduction In the ever-evolving landscape of medical advancements, a groundbreaking study conducted by Resonant, a Utah-based biotech company specializing in diagnostic tests for neurodegenerative diseases, is developing an Alzheimer’s blood test, a potential game-changer in the early detection of Alzheimer’s disease. The research suggests that a simple blood test could be the key to identifying

Unraveling the Mystery: A Comprehensive Guide to the Science, Safety, and Secrets of Keto Gummies and Weight Loss Gummies

Introduction In the ever-evolving landscape of weight loss solutions, keto gummies and weight loss gummies have emerged as tantalizing options, promising to revolutionize the journey to a healthier, slimmer self. As the hype around these supplements continues to build, the pressing questions on everyone’s minds are: Do they really work, and are they safe? In

Novo Nordisk Invested EUR 2.1 Billion in a French Manufacturing Site to Meet Growing Demand for Diabetes and Obesity Therapies

In a strategic move to address the escalating demand for its diabetes and obesity therapies, Novo Nordisk, a global healthcare company, has announced a significant investment of EUR 2.1 billion (USD 2.3 billion) in expanding its manufacturing facility in Chartres, France. This capital infusion aligns with Novo Nordisk’s commitment to increasing production capacity for key

EzriCare Eye Drops Recall: Unveiling a Nationwide Health Crisis

The Centers for Disease Control and Prevention (CDC) recently issued a formal health advisory in response to an unprecedented outbreak of carbapenem-resistant Pseudomonas aeruginosa (CRPA), a bacterium notorious for its resistance to specific antibiotics, thereby instigating severe infections in affected individuals. This concerning development has been traced back to the utilization of EzriCare Artificial Tears

The future of RNA-based Therapeutics  and Vaccines: Introducing advanced, Unrivalled Treatment Approaches

RNA-based therapeutics have completely revolutionized the healthcare segment, greatly influencing the study and treatment of human diseases by conferring precise targeting ability to therapeutic modalities. Further, the enhanced safety and efficacy of treatment using RNA-based therapeutics has surpassed the safety profiles of the conventional treatment approaches. Considering their vast potential, stakeholders are actively engaged in

Unveiling the Future of Liquid Biopsy Market

Cancer is the second leading cause of death globally, and the increasing global incidence of cancer is becoming a critical health challenge. According to WHO, approximately 16.3 million cancer related deaths are likely to occur by 2040. In order to address the growing cancer burden, numerous cancer research organizations are actively adopting innovative strategies and

Prominent Reasons Behind The Failure Of NAMPT inhibitors And Key Strategies Adopted By Developers To Overcome Such Challenges

NAMPT inhibitors are a class of drugs that target the enzyme nicotinamide phosphoribosyltransferase (NAMPT). This enzyme plays a crucial role in the production of nicotinamide adenine dinucleotide (NAD+), a molecule that is essential for cellular metabolism. NAMPT inhibitors work by blocking the activity of NAMPT, which in turn reduces the production of NAD+. NAD+ is

Agricultural Biologicals Market: Current Landscape, Growth Opportunities and Future Market Outlook

The agricultural biologicals market (including biopesticides market, biofertilizers market and biostimulants market) has emerged to be an essential component of sustainable farming practices in order to grow organic food products. These novel bio solutions have the potential to address a number of challenges associated with conventional farming. Presently, over 185 nations worldwide have started adopting

Next Generation RNA Therapeutics and Vaccines – A Marvel of The Lifesciences Industry

In the past few years, Next Generation RNA therapeutics have emerged as one of the key therapeutic modalities in the modern healthcare industry. These RNA based therapeutics play a crucial role in protein production and regulation of gene functions. In addition, they offer enhanced therapeutic and safety profiles as compared to traditional treatment approaches. However,

Decentralized Clinical Trials: The Future of Clinical Research

Over the past decade, the rise of this digital technology has transformed various sectors, from finance to healthcare. One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs). Clinical trials are prospective

Injected Version of Eisai/Biogen Alzheimer’s Drug Works as Well as IV Leqembi

On 26 October 2023, Eisai and Biogen’s Alzheimer’s drug, Leqembi, was found to be as effective as the current intravenous administration in removing toxic brain plaques. However, the review conducted by the drugmakers revealed that the rates of serious side effects were higher when using the drug in its subcutaneous injection form. The company’s analysis

BioNtech Reports Preliminary Phase I/II Results of its CAR T Cell Therapy CarVAC and BNT211-01 (NEO-PTC-01) at European Society for Medical Oncology (ESMO) Conference

On 24 October 2023, BioNtech announced the preliminary results of phase I/II trial evaluating BNT.221-01, a combination of Claudin 6 (CLDN6)-targeted CAR T cell therapy and the mRNA-based CAR T booster CarVac at ESMO conference in Madrid. BioNtech reported acceptable safety and tolerability data and first hints to efficacy in solid tumours. The CAR T

Merck Enters into a Development Agreement with Daiichi for Antibody Drug Conjugates

On 23 October 2023, Merck announced a development agreement for Daiichi Sankyo’s clinical-phase antibody-drug conjugate, namely patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting cancer. Merck has invested $5.5 billion to jointly develop three of its candidate cancer drugs and is likely to invest up to $22 billion in addition depending on

Single-use Bioreactor: An Indispensable Component for Biopharmaceutical Manufacturing

The limitations of stainless-steel bioreactors such as high risk of contamination, process related challenges and high operational cost have prompted innovators to develop more advanced single use bioreactor in order to meet the rising demand for safe and efficacious biotherapeutics. Conventional stainless-steel bioreactors require more energy as compared to the single use bioreactor for sterilization,

HPAPIs – Current Interest of the Pharmaceutical Industry

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe. HPAPIs, due to their selective mode of action, are

RNA Therapeutics: A Novel Approach to Treating Diseases

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. These therapeutics are broadly classified into two categories, namely coding RNAs and non-coding RNAs. Coding RNAs include messenger RNA

Bacteriophage Therapy – A Revolutionary Approach Towards Multi-Resistant Bacteria

Bacteria plays a crucial role in maintaining the ecosystem balance. However, there are few species of bacteria that can cause several infectious diseases (such as strep throat, salmonellosis, tuberculosis, whooping cough). These are mainly transmitted through air, water, living organisms, and food. Further, the spread of infections to a larger population is attributed to the

Biopharmaceutical Filtration: A Deep Dive

Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Filtration plays a crucial role in ensuring the safety, efficacy, and quality of biopharmaceutical products. The biopharmaceutical industry uses different filtration systems depending on

Can The Next Generation Drug Conjugates Revolutionize The Rare Disorder Domain?

Over the last two decades the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to more enhanced, potent, and targeted therapeutics. This led the researchers to find alternative pathways and drug delivery strategies to enhance the potent delivery of the drug to the site of action. As a result, in late

Berkus Method of Start-up Valuation to Evaluate Start-ups Engaged in Digital Twins Domain

Digital twins is a rapidly emerging space and there are several start-ups working to provide novel solutions. In this article, we’ve looked at a method of company valuation. Berkus start-up valuation is a method developed by the American venture capitalist and angel investor, Dave Berkus in the mid 1990’s. The Berkus method was designed to

Agricultural Biologicals: An Answer to a Sustainable Future

The introduction of the Green Revolution in the late 1960s led to a substantial agricultural intensification. The primary objective of the initiative was to feed a growing population with limited land resources and enhanced crop yields. Consequently, the use of agrochemicals, such as chemical pesticides and fertilizers, became an integral part of this industrialized approach.

Pharmaceutical Polymers / Medical Polymers -Current Scenario and Future Potential

Driven by the increasing need for safe and efficient medical devices and drug delivery systems, the pharmaceutical polymers / medical grade polymers domain is advancing significantly. There has been a rise in the development of polymers for biopharma with improved biocompatibility, biodegradability and functionality. It is worth highlighting that the manufacturing of polymers for biopharma

Bioreactor Industry: Current Scenario and Future Trends

Bioreactors and fermenters are complex systems used across numerous sectors of the industry, for the production of pharmaceuticals, nutraceuticals, food, and beverages. These systems provide controlled conditions for cell growth by providing optimum nutrient supply, and oxygenation, enabling the production of biologics. Bioreactors and fermenters can range from small laboratory-scale to industrial-scale systems, and may

Nanoparticle Formulation: A Paradigm Shift towards Novel Drug Delivery

Nanoparticles (zero-dimensional nanomaterials) are ultra-fine particles with overall dimension ranging between 1-100 nm. Owing to their unique size and physicochemical properties (surface roughness, surface area, surface energy, crystal structure and shape), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted

Cryobags – Current Scenario and Future Trends

Since the 1980s, there have been significant advancements in the cryopreservation techniques used for storing stem cells, particularly hematopoietic stem cells and embryonic stem cells, which are essential in various medical applications, including regenerative medicine and biobanking. This can be attributed to the fact that the demand for biologics has been constantly increasing and driven

Wearable Injectors Unveiled: Future of Healthcare

In the continuous evolving landscape of healthcare, wearable injectors have emerged as transformative devices with the potential to redefine patient care. These innovative instruments combine precision, convenience, and patient-centered design to revolutionize drug delivery. In this detailed blog, we will delve deeply into the world of wearable injectors, exploring their underlying technology, advantages, limitations, diverse

Cannabis Testing: Unlocking the Future Opportunities in Healthcare

Cannabis belongs to a class of flowering plants famous for its psychoactive properties and recreational uses. Cannabis sativa is the most widely used variety of the plant; other forms such as Cannabis indica and Cannabis ruderalis are also popular in different regions.  In earlier times, cannabis was used primarily for recreational purposes, however, medical applications

Advancements In Automation Of Manufacturing Processes: Key Value Driver For Escalated Interest In The Cell Therapy Domain

Cell therapies are based on the premise that the patient’s own cells (autologous), or those from a healthy donor (allogeneic), can be genetically re-programmed to combat various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit. It is important

Cryogenic Bags – A Critical Component in the Successful Delivery of Biological Samples and Therapies

Owing to the ability to preserve a wide variety of elements for such a long period of time, including cells, tissues, blood and DNA, cryopreservation has emerged as a key focus area for stakeholders in the biopharmaceutical industry. It is worth mentioning that it is extremely difficult to store biological components, such as stem cells

On Body Injectors: The Future of Drug Delivery

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, heart disorders, neurological disorders and oncological disorders, are on the rise. Therefore, medical technology is rapidly evolving, enabling more advanced and patient-friendly methods of drug delivery. In the pursuit of creating patient-centric healthcare solutions, the medical industry has witnessed

How Can Quantum Computing Technology Help In Pharmaceutical R&D?

The early stages of research related to drug discovery, including the identification of a relevant biological target and a viable lead compound, play a crucial role in the overall success of a drug candidate in preclinical and clinical studies. It is also worth noting that the process of drug discovery is extremely demanding, both in

Companion Diagnostics Services: Future of Outsourcing

In the recent years, service industry has become a fast-growing segment in the overall healthcare domain – thanks to the steady increase in demand for contract research organizations (CROs) and contract manufacturing organizations. The need to focus on developing more efficient interventions, within stipulated timelines and budget constrains is the key driver for outsourcing operations

Breaking the Waves: How Blue Ocean Strategy in Healthcare Can Propel Pharma / Biotech Companies to Success

In the fiercely competitive landscape of the pharma and biotech industries, standing out from the crowd is crucial for success. One strategy that has gained traction in recent years is the Blue Ocean Strategy. By charting new waters and creating uncontested market spaces, companies can differentiate themselves and unlock unprecedented growth opportunities. In this blog

Nutrigenomics: The Future of Personalized Nutrition

Recent advances in DNA sequencing technologies have led to significant developments in healthcare-focused research on precision medicine and diagnostics. Given the recent shift from the one-size-fits-all model to a more personalized mode of treatment, there has been a growing interest for identification and adoption of novel techniques. According to a study, around 20,000 genes are

Digital Manufacturing – Current Scenario and Future Trends

Breakthroughs in the biotechnology industry, over the last few decades, has provided a considerable boost to the overall development landscape of biopharmaceutical drugs. In 2022, a milestone was witnessed when the number of approvals received by biologics narrowly outpaced those reported by small molecules. Further, in the same year, nearly half of the biologic approvals

Biologics Contract Manufacturing: Changing Promise into Reality

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context,

Cell Therapy Consumables Industry: Current Scenario and Future Trends

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Driven by the benefits offered by cellular therapies and recent approvals by regulatory authorities, the demand for such therapies has increased considerably. This trend has

Cell and Gene Therapy CROs: The Next Growth Opportunity

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In recent years, blockchain has garnered significant interest of researchers, as well as industry players, as it has proven to be a versatile tool for decentralized monetary transactions and data exchange in various industries, such as banking, cyber security, supply chain management, government and healthcare. Several stakeholders in healthcare have adopted blockchain for various operations,

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mRNA manufacturing has completely revolutionized the field of medicine and significantly influenced the study and treatment of human diseases. The success of COVID-19 vaccines paved the path for mRNA vaccines and therapeutics. Safety, efficacy and rapid production of mRNA drives the interest in this domain. However, mRNA production is fraught with several challenges as the

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Like any other industry, the healthcare industry is drastically growing in its way. Thus, manufacturers need to update themselves with the new technologies and tools to stay relevant and competitive with the current market trends. Manufacturing execution system plays a crucial role in achieving long term competitive advantages in the healthcare industry. Manufacturing execution system

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The continuously growing demand for healthcare products and present economic environment drives the need for adoption of automated tool and technologies in order to improve manufacturing, process, increase throughput reduce cycle time, maintain quality and to get the best out of the available resources to eliminate unnecessary production costs. It is worth mentioning that in

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Recently, in the biopharmaceutical industry an increasing demand for quality biologics has been observed, where single use bioreactors have emerged as one of the most prominent and reliable solution for biomanufacturing. Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins,

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Over the past 50 years, the medical device industry has seen several notable developments. In fact, the use of biomedical devices, such as medical implants, surgical instruments, and prostheses has increased substantially over the time. Every year, millions of individuals undergo surgeries and implantations. Cardioverter defibrillators, prosthetic hips and knees, contact lenses, and cardiac pacemakers

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In recent years, cell free system / cell free protein expression system have emerged as a promising alternative for the conventional cell-based biomanufacturing process. It is a well-known fact that traditional biomanufacturing is a complex process that requires living cells and specific conditions in order to maintain proper homeostasis for cell growth. Moreover, cell based

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In order to manipulate the cells, genetic material / nucleic acid is artificially introduced into the cells by using specific carriers / vectors. This process is known as transfection. It does not use viral components for transfection and are aimed at circumventing the challenges, such as inflammation, immunogenicity and non-specific transduction, associated with viral vectors.

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The domain of novel cell cytometers, particularly flow cytometer, has attracted much attention within the global biopharmaceutical industry in recent years. This popularity can be attributed mainly to the need of these tools to address the rising prevalence of chronic disease conditions. Flow cytometers allow simultaneous characterization of cells from a mixed population, thereby helping

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Clinical trials are a fundamental requirement for evaluating the safety and efficacy of novel therapeutic interventions. Initiating a clinical trial is a complex and time-consuming process, involving suitable planning and execution. In addition, there are several other challenges, including inefficiencies related to data handling, and difficulties associated with patient engagement solutions, which further complicates the

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Digital health is a broad term that refers to the utilization of communication and information technologies to manage, track, and improve the overall healthcare delivery system. As a part of the growing digital therapeutics market to optimize patient healthcare and the development of pharmaceuticals, the women’s health market has witnessed significant rise in investments in

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Over the past 50 years, the medical device industry has seen several notable developments. In fact, according to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, since 2020, the Food and Drug Administration (FDA) has approved 125 medical devices. The growing demand for complex medical devices,

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A study conducted on terminated drug development projects revealed that majority of the drug candidates fail in early drug development phases, due to the problems associated with their pharmacokinetic profiles, ADME (distribution, metabolism, absorption and excretion) properties and toxicity-related issues. Moreover, it is a well-established fact that the systemic / local absorption and distribution of

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In recent years, liposomes have garnered significant interest of researchers, as well as industry players, owing to their potential in diagnosis and treatment of various diseases, with a focus on delivering drugs and genetic material. Liposomes are small, artificial and lipid-based bilayered spherical vesicles, which are created spontaneously by hydrated phospholipids. Owing to their ability

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Messenger ribonucleic acid (mRNA) is a single-stranded molecule, which carries coding sequence and plays a prominent role in protein synthesis. It transfers genetic information form to DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. Despite the challenges associated, there is a growing need for mRNA production service providers.

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Modified tumor-infiltrating lymphocytes or TIL therapies have emerged as a viable and potent option to selectively eradicate the tumor population, with minimal side effects. Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority (over conventional treatment options) of TIL-based therapies. Their tumor-cell killing efficiency is attributed to the fact that they are

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Considering the rising demand for biologics, innovators in the biopharmaceutical industry are constantly exploring avenues that would enable them to overcome the existing technical and operational challenges related to viral clearance testing for timely approval of biologics. Outsourcing the viral clearance testing studies has emerged as a promising alternative for most of the manufacturers. Despite

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In the last decade, the popularity of AI has grown invariably. Specifically, it has made a considerable impact in the medical sector and oncologic treatment as well, due to a surge in electronic data, breakthroughs in technological infrastructure and groundbreaking research in deep learning neural networks. AI cancer treatment has demonstrated potential in improving liquid

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Over the past decade, numerous scientific and technological breakthroughs in the medical device CRO industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for advanced and minimally invasive medical devices has been augmented due to the increase in expenditure on healthcare. However, one of the primary challenges

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Presently, several industry and non-industry stakeholders are evaluating SARM1 inhibitor as potential therapeutic agent for the treatment of neurological disorders across various preclinical studies and early stages of clinical development, worldwide. Given the encouraging research outcomes, the players in the SARM1 inhibitor market have received more than USD 10 million in grants, since 2014, from

TCR T Cell Therapy: An Emerging Therapeutic Modality

Modified T-cell receptors or TCR T cell therapy is an emerging class of adoptive therapy that employs genetically modified lymphocytes to target specific tumor markers. Structurally, TCR is a heterodimer comprising of two different polypeptide chains, namely the α-chain and β-chain. TCR therapies’ tumor-cell killing efficacy may be primarily attributed to the fact that they

Cell Therapy – The Revolutionary Therapeutic Modality: All Set To Obliterate Oncological Disorders

The American Society of Gene and Cell Therapy (ASGCT) defines cell therapy as a therapeutic modality that involves the administration of either normal or modified cells to patients for the treatment of various diseases. In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of

Applications of Blockchain in Various Sectors: An Introduction

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Healthcare treatment is important for those having fatal diseases and so is the precision treatment in almost every case. One of such disease which has squabbled the entire humanity and accounts for the highest number of death rates globally is cancer. It’s a disease wherein the body’s abnormal cells grow uncontrollably and spread to other

Antiviral Drugs: Are we Prepared for the Next Viral Pandemic?

Infectious diseases are known to be one of the top 10 leading causes of deaths, worldwide. In-fact, more than 40 million people are affected by various types of infectious diseases annually. Further, it has been around three years since the COVID-19 pandemic hit the world, and yet, shows no signs of disappearing. An article published

Artificial Intelligence Pathology:Transforming Medicine

How is Artificial Intelligence being used in Digital Pathology? Artificial intelligence in pathology is a transformative technology that has enabled pathologists to make the shift from visual inspection of tissue samples to automated image analysis. With the advent of AI pathology, researchers are now benefiting from computerized image analysis software that can draw conclusions and

Self Testing Kits: A Transformation in Diagnostic Sector

In the health industry, digitization has evolved over time with numerous advances to ensure that everyone has equitable access to health products and medical specialists.  Self testing kits have the ability to improve health equity and accelerate progress toward universal health coverage, and it has the capacity to alter health care. Self testing kits provide

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Neurological disorders are considered the second leading cause of death and the primary cause of long-term disability, worldwide. In fact, over 6.5 million neurological disorder related deaths are reported annually, globally. Further, according to a report published by the United Nation (UN), close to 1 billion people, across the globe, suffer from various types of

Advancements in Automation of Processes: Key Value Driver for Escalated Interest in Cell Therapies Manufacturing Domain

Considering the vast potential of cell therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapies have garnered considerable attention of players engaged in the healthcare industry, in the past few years. The focus of stakeholders has

CAR-T Cell Therapy: Addressing Key Unmet Needs in Oncology

Amidst the active initiatives undertaken to develop more targeted anti-cancer therapies, CAR-T therapies have emerged as a promising option, given their ability to eradicate tumor cells from the body with minimal treatment-related side effects. Further, CAR-T cell therapy, relatively recent addition to the gamut of anticancer interventions, has demonstrated significant promise. Overall, this highly specific

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The process of drug development and safety testing is extremely expensive and time-consuming. Animal testing is a vital part of drug development process, which is beneficial for researchers in understanding the cause, diagnosis, and treatment of various medical conditions. However, there are several concerns over the validity of animal research; drugs that seem to be

Antibody Drug Conjugates Market: The Future of Novel Therapies

Antibody drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have garnered the attention of pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the therapeutic features of a chemotherapy / cytotoxic drug. Such conjugates

Spatial Genomics – An Amelioration of Tissue Analytics

Recent advances in multi-omics approaches, including genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging, in combination with bioinformatics and biostatistics, have been translated into several popular bioanalytical platforms, such as next-generation sequencing (NGS kits), single-cell analysis, flow cytometry and mass spectrometry. These platforms, although widely adopted, require tissue fixation and are therefore not capable of providing

Targeted Protein Degradation Market: Riding on the Popularity of PROTAC, Market is set to Grow Exponentially

Over the years, the drug hunters have tried to target the tens of thousands of proteins responsible for sickness and health. But a vast majority of them have remained out of reach. While, the scientific evolution has led to the development of potent and selective small-molecule inhibitors of protein function, but still, multiple targets of

Is Blue Ocean Strategy The Silver Bullet For Emerging Teleradiology Players to Achieve A Breakthrough In This Highly Competitive Market?

Blue ocean strategy, a concept first introduced in 2004, by W Chan Kim, and Renee Mauborgne in their bestselling book of the same name, talks about how to achieve a breakthrough in a highly saturated market by focusing on creating a new uncontested market. Blue ocean strategy is a systematic approach that helps emerging service

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Women’s digital health involves the initiatives taken by industry stakeholders and researchers, which include technological remedies, such as mobile apps, software, wearable devices and diagnostic tools that exclusively aid in improving female health and wellness. Since it is primarily focused on women’s healthcare, it is termed as Female Technology or FemTech. The term “FemTech” was

Sustainable Packaging: A Paradigm Shift in Healthcare Packaging

What is Sustainability and Why is Sustainable Packaging Important? The term sustainability is derived from the Latin word sustinere, which means to hold or support. Sustainable packaging is defined as packaging that is safe for individuals, as well as the environment, while meeting all requirements for performance, cost and ease of fabrication. Further, the product should be

Single Use Sensors: A Step Towards Future Transformation

Over the past decade, the pharmaceutical contract manufacturing market has witnessed several advancements in terms of bioprocessing. Bioprocess technology is one of the integral parts of biotechnology that deals with different biological processes involving living or competent cells to get value added products at the end of the process. Recently, an increasing demand for various

Continuous Manufacturing: Meeting the Demand for Drugs and API

Over the last few decades, the pharmaceutical contract manufacturing market has been using batch processes for production of pharmaceutical products, which is a multi-phase process. However, the surge in the demand for drugs due to COVID-19 has led the pharmaceutical industry to shift on to a more agile and flexible technique- continuous manufacturing, which is

Metabolomics Testing: An Emerging Tool in Clinical Research

Scientific fields involved in high throughput measurement of biological molecules are referred with the suffix-omics including, nutrigenomics, transcriptomics, genomics, proteomics and metabolomics testing. Genomics is the study of genetic material within a cell, and transcriptomics is the study of gene activity in different cells. Likewise, metabolomics testing involves the study of by products of metabolism.

Subcutaneous Drugs: The Unmet Need in the Pharma Space

Over the years, the incidence and prevalence of chronic diseases, have increased significantly. Presently, the recommended treatment options for such clinical conditions are mostly biologics, which need to be administered via parenteral routes to ensure maximum therapeutic benefit. Given the inherent requirement for frequent medication, patients suffering from such long-lasting clinical conditions generally end up

Exosome Companies: In-depth Look into Service Providers Market

Over the years, applications of exosomes in therapeutics have undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study. Moreover, various exosome companies have entered into collaborations in order to advance their innovations and offer specialized research expertise, services and technologies. In order to promote the use of

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Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently

Exosomes: A Trending Term in Therapeutic Domain

Exosome Therapy has been of great interest in the recent years due to the discovery of their potential in so many research and analytic procedures. Exosomes are known to have some unique functions, such as their ability to alter recipient cell bioactivities, acting like intercellular messengers and also having therapeutic potential in disease diagnostics as

Pharmaceutical Excipient Market: Current Scenario and the Future

Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical excipient products are

Complement Therapeutics: Treating Complement-Related Diseases

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Next Generation Therapeutics: Novel Therapies for Rare Diseases

Since the approval of Soliris® in 2007, an anti-C5 antibody, the field of complement drug discovery has gained significant attention. Currently, nine complement therapeutics are commercially available, while around 190 molecules are under development for various disease indications. Some of the complement therapeutics, namely Berinert®, Cinryze®, ORLADEYO®, Ruconest® and TAKHZYRO® were approved for the treatment

Peptide Pills: Addressing Key Unmet Needs Across Diseases

Orally administrable protein / peptide pills offer several advantages including, effective treatment of numerous clinical conditions and degenerative disorders. Interestingly, recent advances in this domain have led to the development of several treatment strategies that, according to developers, exhibit the necessary capabilities to overcome challenges posed by traditional oral formulations  and peptide pills. One of the

Intranasal Drugs: An Alternate Route of Administration

The intranasal drugs delivery is widely accepted as effective and non-invasive option for the local and systemic delivery of several types of active pharmaceutical ingredients (API). Majority of such formulations are designed to treat chronic obstructive pulmonary disorders (COPD), asthma and other respiratory diseases. Interestingly, over the past few years, drug developers focused on non-respiratory

Container Closure Integrity Testing for Pharmaceutical Industry

Over the past few years, the pharmaceutical industry is growing a tremendous pace. Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. Therefore, several quality checks are performed to ensure product’s sterility and stability. One of the

DNA Replication Demand: Driving Contract Manufacturing Market

Since the approval of the first antisense therapy in 1998, DNA replication has been in light for their capabilities as therapeutic agents. DNA replication provides a short synthetic nucleotide chain with immense potential in the diagnosis and treatment of a myriad of disease indications. In addition to therapeutics, these complex molecules act as a significant

Next Generation Sequencing: Revolutionizing the Field of Genetics

Next generation sequencing has emerged as an evolutionary technology in modern biotechnology and healthcare research, enabling researchers to better understand the cause and consequences of disease and develop next generation drug conjugates. Over the past few years, several companies have started offering a diverse range of genome sequencing products and services using various second and

Auto Injector: The Rising Need

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, anaphylaxis, rheumatoid arthritis and psoriasis, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. Further, in order to improve the quality of life in these

NGS Library Preparation Kits: Current Scenario and the Future

Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as next generation drug conjugates and personalized medicine. However, the conventional nucleotide library preparation process

Oligonucleotide Therapeutics: A Driving Force for CMOs

In the 20th century, major research went into discovery of a therapeutic class with the primary purpose of interfering with the RNA expression linked to disease causing proteins, nowadays classified as Oligonucleotide therapeutics. These short, single-stranded DNA or RNA molecules, which are the product of DNA manufacturing services, have various applications in biopharmaceutical and biotechnology

Gene Editing Technology: ZFN, TALEN and Meganucleases

Presently, there are several companies and universities, which are exploring the potential of gene editing technology beyond CRISPR for basic research, and the development of gene editing solutions. With the development of a versatile gene editing technology, including zinc-finger nucleases (ZFNs), TAL effector nucleases (TALENs), engineered endonucleases / meganucleases (EMNs) and clustered regularly interspaced short

ADC Payload / Warheads and Rise in its Demand

With six approved drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), and more than 300 candidates in the pipeline (clinical / preclinical stages), antibody drug conjugates (ADCs) have emerged as a promising class of therapeutics for the treatment of various disease indications. Over time, medical researchers have

Clinical Trial Management: Clinical trial site management landscape

Clinical trials form an integral part of the overall drug development process, enabling the necessary evaluation of the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of drug candidate is dedicated to clinical trials; this is equivalent to an expenditure of USD 78

At Home Blood Collection: New Era of Diagnosis and Testing

In the era of COVID-19, where the world is looking for point of care treatment, in order to avoid maintain physical distance. Post the onset of COVID-19 pandemic, there has been a decline in number of patients visiting laboratories for sample collection and testing. To avoid risk of infections, patients have postponed their routine tests

Treg Cell Therapy: A Hotspot in the Field of Immunotherapy

Classification of Treg Cell Therapy The Treg cell therapy (Tregs) is a therapeutic modality based on the mature subpopulation of T-cell therapy that plays a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling homeostasis. These mainly develop in thymus from CD4+ thymocytes and

Site Management Organization: A Trend in the Clinical Trial Domain

Innovators in the pharmaceutical industry are constantly developing ways to improve the process of conducting clinical trial management. Amidst other alternatives, outsourcing various trial operations to a specialized service provider, such as site management organization, has emerged as a viable option for various developers. The advantages of engaging such specialized service providers are numerous and

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DNA data storage involves encoding and decoding binary data to and from synthesized strands of DNA. It offers generous, long-lasting, and stable data storage solution with orders of magnitude relatively higher than current storage mediums. Owing to the numerous benefits offered by DNA data storage as compared to other mediums, it is anticipated that this

HER2 Targeted Therapy: Market Landscape and Future Potential

The epidermal growth factor receptor (EGFR) is a tumor resistance biomarker which plays an essential role in the differentiation and proliferation upon activation through the binding of one of its ligands. A non-ligand-binding member of EGFR family, HER2 exerts its activity through heterodimerisation along with its other family members. HER2 targeted therapy affects the transmembrane

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Biopreservation is the exclusive biological approach designated for the preservation of cells, tissues and organs ex-vivo for the purpose of storage, shipment and transportation. Biopreservation media is one of the most crucial entity in conferring effectiveness. The selection of the type of media depends upon the considerable time duration desired for the storage, type of

Bioassay Services – A Prerequisite for the ATMPs Development

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Rising Need of Wearable Injection Device Platform

With the increasing global population, the incidence rates of several chronic disease indications, such as diabetes, heart disorders, neurological disorders and oncological disorders, are on the rise. This has led to a rise in the demand for effective treatment options for patients suffering from these diseases. Further, in order to improve the quality of life

Pharmaceutical Vials Witnessing High Demand in Pandemic

Over the years, advances in drug / therapy development processes have led the pharmaceutical industry to gradually shift from a one-drug treats all model to a more personalized approach of treatment. The growing complexity of modern pharmacological interventions, such as monoclonal antibodies, and cell and gene therapies, has further prompted the drug developers to develop

Fc Fusion Protein – A New Approach to Drug Therapy

Since the approval of Enbrel®, CD4 – Fc fusion protein (for the treatment of rheumatoid arthritis) in 1998, Fc fusion protein therapies have evolved into a prominent class of therapeutics. Currently, 13 Fc fusion protein based drugs are commercially available, while around 50 molecules are under development for various disease indications. Some of the Fc fusion

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Primary packaging material (e.g. Pharmaceutical Glass Vials) plays a crucial role in preserving the stability, efficacy and safety of the drug as it is in direct contact with the packaged therapeutic. Additionally, pharmaceutical primary packaging material assists in maintaining the sterility and quality of a drug product, while also providing information related to its identity

ADC Therapeutics – Alternative to Traditional Anticancer Therapies

Antibody-drug conjugates (ADCs) are an upcoming class of targeted therapeutic agents that have captured the attention of both large and small pharmaceutical companies, and academic / research institutions from all across the world. Fundamentally, these complex biotherapeutic entities demonstrate the combination of target specificity of an antibody and therapeutic features of a chemotherapy / cytotoxic

Glycoengineered Antibodies – Virtue of enhanced effector functions

With close to 100 approved monoclonal antibodies, and over 550 molecules in the clinical pipeline, antibody based pharmacological interventions have become one of the fast growing segment of the biopharmaceutical industry. In fact, these interventions are anticipated to generate a cumulative sales of USD 300 billion by 2025. Further, within the antibody therapeutics industry, engineered

ADC Therapy – A Potential Tool Against Cancer

Over the years, various technological advancements, such as antibody engineering for site-specific conjugation and enhanced pharmacokinetic and pharmacodynamic properties, have paved the way for antibody drug conjugates to be recognized as potent therapies (ADC therapy) targeting a wide range of indications, including solid tumors and hematological malignancies. ADC therapy is an engineered therapy comprised of

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Green Packaging in pharmaceutical secondary packaging industry plays a crucial role in ensuring the sterility and quality of a drug product, while it also provides information related to its identity and, in certain cases, dosing instructions. Pharmaceutical packaging is typically carried out under Packagingcontrolled conditions; specifically, for therapeutics that are designed for parenteral administration, fill

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Alzheimer’s disease is a progressive neurological disorder characterized by the death of brain cells, eventually leading to memory loss, cognitive dysfunction and dementia. Accounting for 60-70% cases of dementia, Alzheimer’s disease is known to be the sixth leading cause of death in the US.   Presently, more than 6 million Americans of all ages are living

Cell Therapy Packaging Market – Importance and Future Potential

Over the years, the pharmaceutical industry has witnessed several advancements in drug development. It has gradually shifted from a one-drug treats all model to a more personalized approach of treatment, which involves the use of personalized cell and gene therapies for various disease indications. This shift has led to an evident change in the pharmaceutical

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Since John Steele, John Richardson, and Jerzy Olszewski first described Progressive Supranuclear Palsy (PSP) in 1964, the neuroscience community has been on the lookout to find a “miracle molecule” or an “elixir” that can cure patients diagnosed with this debilitating disease. With more than 2,000 research studies published so far, the progressive supranuclear palsy domain

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Teleradiology services is a branch of telemedicine that uses telecommunication systems for the transmission of radiological images from one location to another. Additionally, it helps the radiologists to interpret various types of images, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound, and X-rays, remotely. As of late, teleradiology have

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In the era of digitalization where the world is looking forward towards automating their manufacturing process, the bioprocess industry took a while to adopt the automation technology. The biopharmaceutical industry came across several obstacles while adopting the automated technology. Examples of which include, complexity of the processes and delicacy of the living cells and organisms

Drug Reconstitution Systems: Reconstitution of Drug and Delivery

The novel drug reconstitution systems have emerged as a promising alternative to traditional methods of reconstitution, adding significant value to the storage and transfer of lyophilized therapeutics. These systems enhance the portability, efficiency and optimum delivery of the lyophilized drugs and have the potential to reduce the number of steps significantly, which enable the dilution

Reconstitution Medication: Reconstitution of Lyophilized Drug

Lyophilization of Pharmaceuticals and Reconstitution Medication In 2018, seven out of ten top-selling prescription medicines were biologics. The liquid formulations of biologics are not much stable and tend to loose efficacy with time due to the changes in their pharmacokinetic and pharmacodynamic properties. Therefore, lyophilization of such drugs is essential before their storage. Around 50%

CMO Manufacturing and The Rising Adoption of Novel Processes

Recent developments in pharmacology and biotechnology have been able to drive significant advances and innovation in understanding the root causes of various diseases; this has further aided in the discovery and development of more targeted treatment strategies. It is worth noting that such advances in the healthcare industry have made pharmaceutical development and CMO manufacturing

Clinical Trial Design: What Does the Future Hold?

Over the years, clinical research has undergone an evolutionary change, in terms of cost of research, technology used, and duration of the study. It is worth highlighting that clinical research involves two major steps, namely study design and study reporting. Further, study design involves three key steps, theoretical design, data collection design and statistical analysis

Pharma CMO: The Solution to Production of Complex Substances

The inherent expertise of CMOs and CDMOs is believed to be capable of enabling reduction in the time-to-market a product, significant cost-benefits, as well as access to larger production capacities and novel technologies.  It is worth mentioning that there has been substantial merger and acquisition activity in the pharma CMO market in the past few

Phage Display Libraries: Where do we stand?

Over time, a variety of methods / approaches have been developed for the generation of viable therapeutic leads. These include the hybridoma technology, B-cell cloning, transgenic animal-based techniques, in vitro display methods (using phage display, ribosomes, mRNA, and cDNA) and cell surface display methods (involving mammalian, yeast, and bacterial cells). Despite being responsible for the

TPD – Targeted Elimination of Disease Causing Proteins

Targeted protein degradation (TPD) is an emerging therapeutic modality that has the potential to enable the treatment of difficult-to-treat diseases. While conventional medicines, such as small molecule inhibitors and monoclonal antibodies, address fewer than 20% of the proteome, TPD offers a unique means to tap into the rest of the vast, unexplored proteome. Through TPD,

Continuous Manufacturing System Providers

Over the years, several industries have implemented evolutionary changes in their respective manufacturing processes. One to the most rewarding advancements in this direction, is process automation. In pharmaceutical contract manufacturing, the automation of various aspects of the production process has led to the establishment of the continuous manufacturing system providers. However, the transition to continuous

Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome is a condition in which the ovaries produce abnormal amount of androgens (males sex hormones), higher than the amount usually present in a woman with normal ovaries. The ovaries develop fluid filled sacs, known as follicles, which contain an immature egg. However, in polycystic ovary syndrome, none of the eggs mature and

Cell Line Development: An Ocean of Opportunities for Stakeholders

The growing pipeline of monoclonal antibodies, vaccines, enzymes, biosimilars and other therapeutic proteins have created an ever- increasing demand for highly- productive and stable cell lines. Many of the recombinant biotherapeutic products, produced in cellular systems, have been translated into commercial successes; these include ALPROLIX®, ELOCTATE® and ELAPRASE®.  Given their impact on the overall quality

Modular Cleanroom: A Paradigm Shift in Pharmaceutical Facilities

The concept of modular cleanroom has long been employed in other sectors, but it has only recently acquired traction in the pharmaceutical business over the last two to three decades. Modular cleanroom construction is a process wherein factory-produced, pre-engineered building units, which are constructed offsite under controlled plant conditions, are assembled on site to construct

Intracellular drug delivery – solution to undruggable targets

Over time, advances in molecular biology and pharmacological chemistry have enabled the identification of biological targets localized in the subcellular space, and development of therapeutic leads against them. In fact, there are several clinical conditions, which were previously considered undruggable since the traditional small molecule-based interventions were unable to penetrate the selectively permeable cell membrane.

Antibody Purification: The Service Providers Landscape

Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are characterized by high costs and technical complexities, especially during the production and downstream processing steps. Therefore, it is challenging for new entrants and companies with limited resources and capital, to

Antisense Oligonucleotides – Gene Silencing Revolutionized

Oligonucleotide (commonly referred to as oligos), are short single stranded DNA or RNA molecules, typically containing 15-20 nucleotide residues.[1],[2] In the modern biopharmaceuticals and biotechnology, the applications of these molecules are vast, including (but not limited to) genetic testing, fundamental biomolecular research, and forensic analysis. Antisense oligonucleotides are a diverse class of therapeutics that are

Fibrotic Disease Diagnosis: A Step Towards Painless Detection of Fibrosis

Advances in the field of biotechnology have enabled the development of several minimally invasive / non-invasive approaches for diagnosis of fibrotic disease which include imaging diagnostics and biomarker-based assays. Among the biomarker-based tests, liquid biopsy (based on the analysis of biofluids such as blood, urine and / or plasma), a relatively new concept, has emerged

STING Pathway Targeting

Stimulator of interferon genes or STING, discovered by the laboratory of Glen N Barber in 2008, is one of the signaling proteins that is responsible for the transcription of genes associated with the innate immunity of an individual. Amidst the recent COVID-19 pandemic, it has become even more essential to strengthen the immune system. The

Virtual Clinical Trials: The Present And Future Of Pharma Research

The lack of patient centricity in traditional clinical trials is known to inhibit trial sponsors to retain enough patients, which is critical to successfully complete safety and efficacy evaluations of novel therapeutic interventions on predetermined completion dates. In addition, the lack of participant compliance in clinical trials often leads to massive delays which are known

Biopharma CRO: Fueling the research of novel biologics

Biologics, often referred to as biopharmaceuticals or large molecules, are manufactured in the biological system, such as microorganisms, plants, or animal cells. Biologics contract manufacturing organizations represent one of the fastest growing segments of the pharmaceutical industry. This can be attributed to the rapid pace of innovation in this field, driven by the need for

Biologics CMO: Industry Outlook and the Growing Pipeline

The recent years have portrayed the renaissance in the domain of biologics, as pharmaceutical industry has once again gained attention towards the production of bioproducts. In fact, in 2019, a total of 28 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapy) were approved in the US. Further, over 8,000 biological pharmaceutical products are

Digital Biomarkers: The Incessant Rise in Demand

Biomarkers or biological markers are distinctive physiological features in an individual, which can be detected and quantified in order to gain insights about health and disease, one common example is a cancer biomarker, marking the presence of malignant cells within the body. On the other hand, digital biomarkers are defined as digital means that are

Artificial Intelligence in Drug Discovery

Drug discovery is a complex process which involves significant utilization of time and resources. As per several sources, on an average, the entire drug development process (from initial proof-of-concept to commercial launch) takes around 10-15 years and capital investments worth USD 4-10 billion to develop a drug from concept to commercial launch. The early stages

mRNA Vaccines: What Lies Ahead?

Messenger RNA (mRNA) is a single-stranded molecule, which is complementary to the DNA strands of a gene. It plays a prominent role in the process of protein engineering, wherein mRNA is responsible for transferring genetic information from DNA to ribosomes, a specialized structure, or organelle, which decodes genetic information into a protein. In the last

Antibody Drug Conjugates Manufacturing: How Are the Contract Manufacturers Supporting the Growing Demand

Antibody Drug Conjugates (ADCs) manufacturing known as the 21st Century Magic Bullets, have emerged as a promising class of targeted therapies being developed for the treatment of cancer. Two decades ago, in the year 2000, the domain witnessed the approval of first ADC known as Mylotarg®, by the US FDA.  This was followed by the

Single Cell Technologies: A New Era of Gene Expression Analysis

For developing an improved understanding of the interactions of individual cells within their microenvironment, advanced molecular probing solutions are being used by researchers across the globe. In this context, high-throughput single cell technologies, have emerged as a powerful analytical technique for studying individual cells, enabling researchers to study gene expression at single cell resolution. Single

Microbial Fermentation: Growing Microbial-Based Biologics Pipeline

The recent years have portrayed the renaissance in the domain of microbial fermentation, as microbial biopharma industry has once again gained attention towards the production of biologics using microbial expression system. The modification and innovation in the microbial fermentation based expression systems for the production of various biologics have side-lined some of the earlier concerns

Handheld Ultrasound Scanner: Revolutionizing Diagnostic Imaging

Advancements in the field of disease diagnostics have led to development of point of care diagnostics market; handheld ultrasound scanner has emerged as a novel solution to cater to unmet need in this domain. The handheld ultrasound scanner is the lightest portable ultrasound device, which permits patient diagnosis from a single transducer and transmit images

Digital Therapeutics: Key Concepts to Tackle COVID-19 Pandemic

Digital therapeutics are clinically validated applications / software / online programs that have demonstrated the capability to facilitate positive outcomes when used in the prevention / treatment / management of diseases / clinical conditions. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications, providing

Intranasal Drugs: A Deeper Look into Service Providers Landscape

The techniques used for the drug delivery are found to be have an enormous impact on the efficacy of the treatment. In fact, the slow progression of the efficacy, has suggested the need of different approaches for the effective delivery of drug (such as intranasal drugs) to the target area, along with the optimal bioavailability.

Targeted Drug Delivery System: Improving the Efficacy of Biologics

The gradual shift of healthcare industry towards the development of biologics is a well-known fact. Owing to this shift, there are over 1,000 cell and gene therapies which are being developed for the treatment of various disorders, majority of them being oncological disorders, cardiovascular disorders and neurological disorders.  Additionally, over the last decade, multiple immunotherapies

Radiopharmaceutical Manufacturing : Radioactivity In Healthcare

Fostered by partnerships between national laboratories, academia, and the pharmaceutical industry, the field of nuclear medicines and radiopharmaceutical manufacturing industry has evolved over the past few decades, in parallel with advances in imaging instrumentation, radionuclide production, and radiopharmaceutical development. Nuclear reactors and particle accelerators are presently used to produce a wide array of radionuclides for

Microbial Fermentation Companies: Impact of the Pandemic

Since the discovery of recombinant DNA technology, several types of microbes have been established as a versatile biomolecule expression system. This can be attributed to the ease of handling of microbial cell lines, which are considered less fragile (compared to cells of higher eukaryotes); rendering them a popular choice for manufacturing operations. Moreover, incremental evolution

Drug Repurposing – A Deeper Look into Service Providers Market

Over the past decade, several scientific and technological breakthroughs in the drug repurposing industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for effective repurposed drugs in the on-going war with the pandemic, is on the rise. However, one of the primary challenges faced by this industry

Antibody Manufacturing Outsourcing Activities

In recent years, contract manufacturers have become an integral part of the overall biopharmaceutical market. This trend is also gaining popularity within the antibody manufacturing market, as developers are increasingly outsourcing their antibody manufacturing requirements to contract service providers. This can be attributed to the fact that employing such third-party service providers offers various advantages,

Wearable Injectors: Simplifying Chronic Disease Management

The last few years have witnessed a rising incidence of chronic illnesses across the globe. Long term clinical conditions, such as neurological disorders, cardiovascular disorders, chronic pain and oncological disorders, have been shown to impose a significant burden on the modern healthcare system and those who suffer from such diseases. It is reported that about

Human Microbiome: Significant Potential of Gut Flora

Human Microbiome Therapies are Viable Alternatives to Antibiotics, with Substantial Therapeutic Potential The term microorganisms was perceived to be synonymous to harmful, disease causing agents, until the discovery of certain beneficial microbial colonies in the human system. Currently, humans and a variety of species of bacteria, yeast and protozoa, are known to co-exist in mutually

Medical Device CRO – The next Growth Opportunity

Over the past decade, numerous scientific and technological breakthroughs in the medical device CRO industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the

Fill Finish Services: Impact of the Growing Biopharma Pipelines

Biopharmaceuticals represent the most rapidly growing and high-value segment of the pharmaceutical industry. Growing at an annualized rate of ~10%, the biologics contract manufacturing market stands tall with more than 5,000 biologics in development and over 300 FDA approved biologics, since 2002. Biologic drug development is characterized by high quality standards and a rapidly growing

ADME Testing Services: Rising Opportunities for Service Providers

According to the US Food and Drug Administration (USFDA), less than 10% of investigational new drug (IND) candidates progress beyond the submission of a new drug application (NDA); this implies that majority of the drug / therapy candidates fail to reach the market owing to unacceptable safety and efficacy profiles and the problems associated with

Autoinjectors: Increasing Demand for Self-Administration Devices

Over the last decade, autoinjectors have emerged as a promising therapeutic commodity for safe administration of parenteral therapies. Patients who suffer from chronic diseases, such as diabetes, rheumatoid arthritis and multiple sclerosis, often require frequent dosing of medication which poses significant inconvenience to them for visiting proper healthcare centers. Hence, autoinjector devices enable such patients

Peptide Therapeutics – A Deeper Look Into the CMO Market

The recent years have portrayed the renaissance of peptide therapeutics, as pharma industry has once again turned its attention towards the potential of therapeutic peptides. Adoption of peptide therapeutics agents have side-lined some of the earlier concerns associated with them, such as drug bioavailability enhancement, and has led to manufacturing of high-quality peptide therapeutics in

TPD: A Major Therapeutic Modality in the Coming Decade

The targeted protein degradation (TPD) approach is believed to possess the potential to unlock the undruggable proteome profile, which was traditionally considered to be inaccessible. Compared to conventional inhibition strategies, TPD offers several benefits, which include the opportunity to completely remove aberrant proteins and associated systemic malfunctions. As a result, TPD-based therapeutics have generated enthusiasm

Targeted Protein Degradation – A New Frontier in Modern Medicine

The concept of targeted protein degradation (TPD) presents revolutionary drug development opportunities and is anticipated to bring about a paradigm shift in modern healthcare. While conventional medicines, such as small molecule inhibitors and monoclonal antibodies, address fewer than 20% of the proteome, targeted protein degradation offers a unique means to tap into the rest of

Computer Aided Drug Discovery Providers for Large Molecules

Over time, the complexities associated with drug discovery have increased, especially in case of large molecule drugs, which are inherently more complex than conventional small molecules. As a result, an increase in the overall research and development (R&D) expenditure in the pharmaceutical contract manufacturing / biotechnology sector has been witnessed. In addition to the complexities

In Silico Drug Discovery: Drug Discovery Operations in COVID-19

The COVID-19 pandemic is predicted to throw the global economy into recession, with loss of trillions of dollars. The pharmaceutical industry cannot escape the brunt of the circumstances as well. In fact, according to a survey, 95% of healthcare industry professionals are worried about the impact the pandemic is likely to have on the industry. So far,

Immune Checkpoint Inhibitors: Another Big Opportunity

There is an urgent unmet need for developing innovative and effective cancer therapeutics for the treatment of patients with late-stage and refractory cancer. Amidst the widespread initiatives to develop more targeted anti-cancer therapies, immune checkpoint inhibitors emerged as a highly specific and potent option to eradicate tumor cells with minimal side effects. Once the body

Ophthalmic Drugs Contract Manufacturing Market

In the past two decades, advances in optometry, along with an increased understanding of human eye and vision care, have led scientists to develop innovative treatment methods in order to treat eye disorders and to overcome the limitations offered by conventional medical practices. The current ophthalmic diseases treatment landscape is characterized by a number of

Ophthalmic Medication: Outsourcing has become a popular trend

Owing to various reasons, such as growing manufacturing demand, need for specialized facilities, equipment and operational expertise, and high costs of development associated with certain drugs / therapies, a number of innovator companies have demonstrated a preference to outsource certain aspects of ophthalmic medication development and production operations to contract service providers. Over 240 companies

Microbiome Manufacturing: Opportunities for Specialized CDMOs

What is the current development pipeline of microbiome manufacturing based live biotherapeutics? With over 85 products under preclinical and clinical development, the current development pipeline of microbiome manufacturing based live biotherapeutics has several promising candidates, which are anticipated to get commercialized over the next few years. Hence, the demand for R&D and manufacturing services for

ANTIBODY DRUG CONJUGATES: THE RECENT APPROVALS

Antibody-Drug Conjugates (ADCs) have captured the attention of both large and small pharmaceutical companies, and academic / research institutions, engaged in the ADC contract manufacturing market. For the past few years, several failures of clinical trials were blamed for the lack of interest of some companies in this therapeutic approach. However, after a decade-long dribble

Needle Free Injection System: Simplifying COVID-19 Treatment

The apocalyptic images of the COVID-19 induced locked-down world are heart wrenching. All healthcare related domains are being created at a rapid rate. Around the world, the coronavirus pandemic is overstretching health services and reportedly more than 40 companies have boosted their R&D efforts to hit the bulls eye and deliver the much awaited coronavirus

CRISPR Gene Editing: A Solution to Address COVID-19

As we know, COVID-19 is causing large scale loss of life and severe human suffering. With the pandemic spreading across the globe, researchers are racing against the clock to develop diagnostic tools, coronavirus preventive vaccines and treatments. Recently, WHO has launched a Solidarity clinical trial to assess relative effectiveness of four potential drugs against COVID-19.

Microbiome Therapeutics Fuel the Manufacturing Demand

Microbiome therapeutics are fragile bacteria, which require ideal conditions of heat, moisture and pH of products, to survive and prevent premature germination. In fact, microbiome manufacturing is presently one of the biggest bottlenecks in this domain; manufacturing such products is both technically challenging and financially demanding. One of the biggest challenges in the development of

Oligonucleotide Drugs Pipeline Escalates Manufacturing Demand

As therapeutic agents, oligonucleotide drugs are known to be associated with several unique features, such as high selectivity and potency (similar to biologics), and differentiated pharmacology, which further augment their drug-like properties. At present, eight oligonucleotide drugs are available in the market, namely (in reverse chronological order of year of approval) GIVLAARI™ (2019), ONPATTRO® (2018),

Oligonucleotides: A Response to COVID-19 Pandemic

Never before, scientists say, the universal community of researchers have put a halt to all other ongoing research and have urgently focused towards swiftly evolving health emergency. In the past few months, scientists have been repurposing their research efforts towards oligonucleotides contributing to the global effort in response to developing coronavirus preventive vaccines. For the

Biopharma Contract Manufacturing Market in China: Covid-19 Impact

China, epicenter of the COVID-19, is the world’s second largest pharmaceutical market and accounts for 20 % of the global output of APIs. With over 25 biologics and biosimilar products approved till date and close to 1,000 clinical trials, investigating a variety of biologics and biosimilars, being underway in this region, the biopharma contract manufacturing

Neoantigen Targeted Therapies: Personalized Anti-cancer Therapy

Neoantigen Targeted Therapies Pave the Way to Personalized Anti-cancer Therapy There is an urgent unmet need for developing innovative and effective cancer therapeutics for the treatment of patients with late-stage and refractory cancer. Amidst the widespread initiatives to develop more targeted anti-cancer therapies, immunotherapy emerged as a highly specific and potent option to eradicate tumor

Collaborative Robots: The Future of Manufacturing

The world has experienced a radical change with the advancements in technologies and systems that aid daily activities. Particularly, lab automation has played an important role in increasing the productivity and quality of the production process in various industries. Within the automation industry, robots have already been established; however, one of the fastest-growing segment of

Collaborative Robotics Helping in Pandemic Management?

With the new threat to humanity presented by Pandemic COVID-19, another bigger challenges for the pharmaceutical industries are bulk vaccine production in the limited time span. How will the pharma sector be going to cope with these challenges? Well, lab automation has always improved the quality and efficiency of the production process in the pharmaceutical

Prefilled Syringe: Impact on COVID 19 and Vaccines

Coronavirus(COVID 19) is spreading around the world, with 2.6 million global active cases. Till date, there are no approved treatments for COVID-19. However, multiple pharmaceutical companies are doing research at breakneck speed to develop therapeutics and coronavirus preventive vaccines against this novel virus. The pharma industry is hoping to compress the development timelines to get

COVID-19: Drugwatch – 6 April 2020

To date, there are no approved treatments for COVID-19. However, the pharmaceutical industry is abuzz with activity as medical researchers strive to develop a cure, and possibly a vaccine, for the illness caused by the novel coronavirus. In this article, we have attempted to explore some of the more popular treatments / preventive measures that

COVID-19: Where are we today?

Comparison with other communicable diseases According to worldometers.info, as of 5 April 2020 (5:30 PM GMT), the total number of COVID-19 cases rose to over a million, with a reported mortality rate of 5%. Further, a comparison with certain other communicable disease-related deaths (Figure below) presents a worrisome situation. As of 5-April 2020, the novel

Cell and Gene Therapy Manufacturing: COVID-19 Impact

With close to half-million infections and the economy showing signs of the 2008 financial crisis, COVID-19 has impacted several industries. Government institutes and industry players have announced various steps to deal with the ongoing situation. In this article, we will highlight the developments in the cell and gene therapy manufacturing industry amid the ongoing COVID-19

Gene Therapy Companies: Impact on COVID-19

In a recent press release, bluebird bio, one of the leading gene therapy companies, announced that COVID-19 has delayed the EU launch and US filing of the company’s gene therapy candidate Zynteglo (LentiGlobin). The company now expects to dose the first commercial patient with Zynteglo in Germany in the second half of 2020. Earlier, the company had

Virtual Clinical Trials During COVID-19

The ongoing COVID-19 pandemic has been nothing short of a nightmare. As the number of infected patients approaches 400,000, there is already a sense of worry looming across the industries. From disrupted supply chains to a prominent decrease in demand, the pharmaceutical industry is also facing its share of difficulties. A prominent shift towards the

Biomarkers in Cancer: Benchmarking Big Pharma Activity

Over the past few years, therapeutic advancements in conventional treatment paradigms have led to an increase in survival among cancer patients. Recent developments in the field of immuno-oncology, such as the introduction of several liquid biopsy techniques, adoptive T-cell therapies, and immune checkpoint inhibitor based therapies, have demonstrated significant potential, and some of the aforementioned

Cell Therapy Manufacturing: Here are the Key Innovations

Last week, during our weekly industry update sessions, our prime focus was to understand the recent innovations in the field of cell therapy manufacturing. We were also looking out for players that are driving these innovations. To start with, the first news that caught our attention was Novartis’ decision to sidestep Europe travel ban to

Cell Therapy and The Rise of Novel Technologies

Roots Analysis has actively tracked the developments in the field of cell therapy and gene therapies. The team has focused on identifying the key challenges that are hampering the growth of these revolutionary therapies. To identify the challenges, the team has interviewed several stakeholders involved in cell therapy development and manufacturing. In addition, a recent

Vector Manufacturing Market: Opinion Leaders Highlight Key Concerns

The growing pipeline of cell and gene therapies has led to an increase in demand for high-quality gene delivery vehicles and, therefore, has created significant opportunities for companies with expertise in manufacturing viral and non-viral vectors. In an article published last year, I discussed the growing cell and gene therapy market and how it has

CMO, CMO Everywhere, Not a Single One That Fits: The Reality of Biopharma Contract Manufacturing Market

I was recently involved in a discussion with the global outsourcing manager of one of the big pharma companies. The premise of the discussion was around the criteria that big Biopharma Contract players follow for choosing a supplier for their products. One key question that came up in the discussion was whether one-stop-shops are really

Evolution of Cancer Diagnostics: Rise of Novel Non-Invasive Methods

Cancer diagnosis, today, employs a mix of invasive and non-invasive strategies. Invasive cancer diagnostic methods are generally expensive and uncomfortable. Biopsies have been the gold standard to determine the clinicopathological characteristics of cancer tissues for many years. The procedure is very uncomfortable and painful for patients and in many cases, the results are known to

CAR T Cell Therapy: Autolus Presents Data on AUT06NG

Autolus Therapeutics, a clinical-stage biologics contract manufacturing company developing next-generation programmed T cell therapies for the treatment of cancer, presented pre-clinical data on AUTO6NG, the company’s next-generation GD2-targeting CAR T cell therapy, at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). What did the results highlight: The results demonstrated the utility of

Microbiome: New Study Uncovers Role of Bacteria in Bowel Cancer

Dr. Kaitlin, from the University of Bristol, speaking at the 2019 NCRI Cancer Conference, confirmed that they have discovered evidence of the presence of an unclassified type of bacteria from the bacterial group named ‘Bacteroidales’ increased the chances of bowel cancer by 2 to 15 percent.  The researchers employed the technique known as Mendelian randomization to

New Research in ALS – Mitoautophagy Responsible for Development of Early Stages of Neurodegeneration

Researchers at Northwestern Medicine have discovered a new phenomenon in the brain that could explain the development of early stages of neurodegeneration seen in diseases such as ALS, which affects voluntary muscle movement such as walking and talking Mitoautophagy. What is the discovery: The researchers have invented a new term to describe the discovery: Mitoautophagy,

FDA Approves Celgene’s REBLOZYL® for the Treatment of Anemia

The U.S. Food and Drug Administration FDA approves Celgene’s REBLOZYL® (luspatercept-aamt) for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. What is Beta-thalassemia: Beta-thalassemia is a blood disorder that reduces the body’s production of hemoglobin. Low levels of hemoglobin lead to a shortage of mature red blood cells and a lack of oxygen in the

CAR-T Pipeline Update: Celgene posts pivotal data ahead of FDA filing

Celgene has recently published positive data from a pivotal trial (NCT02631044) of its CAR-T therapy. As per the reports, the data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year. This is a big news for the overall CAR-T pipeline. As per the reported data, the

New Real-World Data Unveiled at ACAAI Indicates Comparable Clinical Practice Logistics to Implement Oral Immunotherapy and Environmental Allergy Shots

In a recent press release by Aimmune Therapeutics, the company reported that the Clinical Practice logistical needs for implementing oral immunotherapy (OIT) for food allergies, such as peanut allergy, into clinical practice are comparable to those for subcutaneous immunotherapy (SCIT) for environmental allergies. These data were presented at the American College of Asthma, Allergy and Immunology

Party Like Celebrities: American Gene Technologies Hosts a Red Carpet Event to Celebrate IND Submission

On November 6, 2018, American Gene Technologies (AGT) announced that it will host a red carpet event to celebrate a significant milestone in the company’s 11-year history of scientific research in cell and gene therapy. Last month, the company successfully submitted its Investigational New Drug (IND) application to the Food & Drug Administration (FDA) to

T-Cell Therapies Funding Update: Tmunity Raises $75 Million in Series B Funding

On 31st October 2019, Tmunity Therapeutics, a private biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell Therapies, announced the closing of $75 million Series B financing. Who were the key investors in T-cell Therapies: The financing was led by Andreessen Horowitz (also known as “a16z”). Joining the

Avantgen Enters a Strategic Collaboration Agreement for its NK Cell Engager Technology

On 7 November 2019, AvantGen, a biotechnology company with its array of technology platforms for antibody discovery, optimization, and novel NK cell engager generation, announced a strategic agreement with an undisclosed biopharmaceutical company for the purpose of generating multiple novel bi-specific NK cell engaging therapeutic antibody product candidates. Under the terms of the agreement, AvantGen

Genome Editing Services Market Snapshot

The rising demand for genome editing services has resulted in the rise of several players with a wide range of capabilities. Currently, there are close to 80 players that claim to offer CRISPR based genome editing services. To get more insights about the market, check out the detailed report market report – Genome Editing Services.

More than 50 Large Volume Wearable Injectors are Available / Under Development

Over time, both drug developers and medical device Injectors manufacturers, have entered into strategic alliances to combine their respective expertise and develop appropriate drug-device combination products. Presently, multiple such combinations, facilitating easy delivery of both insulin and non-insulin drugs, in large volumes, are either already available in the market or under development. Check out more

Auristatin Emerged as Most Popular ADC Payload

Antibody drug conjugates are a promising class of therapeutic drugs accepted worldwide for the treatment of cancer. ADCs comprise monoclonal antibodies that are conjugated to the cytotoxic payload via linkers that are directed towards the targeted antigen expressed on the tumor cell surface—resulting in toxicity and initiating killing action. The Antibody drug conjugate market provides

ADCs Pipeline Update: Daiichi Sankyo Initiates Clinical Trial

On October 31, 2019, Daiichi Sankyo and Sarah Cannon Research Institute announced the dosing of the first patient in a first-in-human phase 1/2 study (NCT04145622) evaluating DS-7300. What is DS-7300: DS-7300 is an investigational B7-H3 targeting antibody-drug conjugate (ADC). What is B7-H3: It is a Type I transmembrane protein belonging to the B7 family, which includes immune checkpoint

Cancer Biomarkers and Rise of TMB

Over the years, several cancer biomarkers have been identified, which can be used to predict response to certain types of immunotherapy drugs. However, due to the inherent complexity of the immune microenvironment and differences in the genomic makeup of individual patients, most of these biomarkers in cancer have been proven to be insufficient in predicting

ADCs Pipeline Update: Femtogenix Presents Novel Data on ADCs Containing Reduced Potency Payloads

Femtogenix, a UK based biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, announced data demonstrating the potent efficacy and favorable toxicity profile of a reduced potency analog from its Pyridinobenzodiazepine (PDD) ADC payload platform in solid tumor models. The presented data demonstrated that Femtogenix’s reduced potency payload has a favorable

Cell Therapy Manufacturing: A Rising Opportunity for Stakeholders

The Compal Group’s Raypal Biomedical and Kaohsiung Medical University Chung-Ho Memorial Hospital on October 22 signed an MoU to jointly set up a GTP (good tissue practice) cell therapy manufacturing laboratory in Kaohsiung City, southern Taiwan. What are the key capabilities of Raypal in cell therapy manufacturing: Founded in 2016, Raypal specializes in R&D of

Gene Therapy Pipeline Update: Orchard Therapeutics Presents Data on Metachromatic Leukodystrophy

Orchard Therapeutics, a commercial-stage biopharmaceutical company, announced initial results from a clinical trial (NCT03392987) with a cryopreserved formulation of OTL-200, gene therapy in development for the treatment of metachromatic leukodystrophy (MLD). Get the details of the results here. What is OTL-200: OTL-200 is autologous CD34+ cells transduced with a lentiviral vector containing human arylsulfatase A (ARSA) complementary deoxyribonucleic