Research Insights

With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide

The biopharmaceutical industry has been witnessing a significant paradigm shift in R&D outsourcing over the last few years. Specialty CROs have emerged as credible players in the market to overcome the shortcomings of full service / traditional CROs. Often, these full service providers offer a wider portfolio of services but fail to align their efforts to meet the requirements of sponsors, primarily the smaller biotech organisations / start-ups. Specialty CROs, on the other hand, specialize

Peptide therapeutics, due to their numerous advantages such as high selectivity, stability, efficacy, safety, bioavailability and tolerability offer a number of benefits over other therapeutic classes. In addition, peptides (when compared to proteins) are much smaller in size and can be easily synthesized, optimized and evaluated as viable therapeutic solutions for a number of diseases. These highly favourable and intrinsic characteristics of peptides have caused an evident shift in the interest

The term “microbiota” refers to specific clusters of commensal, symbiotic and pathogenic microorganisms that reside in various regions on and within the human body. The human microbiome is involved in various functions that are essential to lead a healthy life. Majority of the microorganisms benefit humans by supplementing them with traits that they would otherwise not possess. These include metabolism of complex carbohydrates, renewal of gut epithelial cells and prevention of growth

The ADC market is being driven by the sales of ADCETRIS® and KADCYLA®, the only two commercially available drugs. It is a relatively new concept with respect to technology, although the individual molecules that form ADCs have been used since long. This new class of therapeutics has witnessed a strong acceptance from both big and small pharmaceutical companies as they try to fill gaps in their respective oncology pipelines. There has been a healthy growth in the number of pipeline molecu

Infusion pumps are a class of drug delivery devices that have found wide adoption across different application areas. Their popularity can be attributed to their reliable, user friendly features and ergonomic design. The market has a wide array of different types of infusion pumps (volumetric, syringe, implantable, elastomeric, ambulatory and others); combined, they offer a large range of infusion volume, flow rate, occlusion alarm pressure range and many other technical parameters that can be a

Discovered less than two decades ago, RNAi has made its presence felt in all spheres of the pharmaceutical industry. RNAi is a natural post-transcriptional process of gene silencing involving short strands of nucleic acids. It is a regulatory process that cells utilise to silence and/or inhibit gene expression through the destruction of specific mRNA molecules. One of the major advantages of RNAi is that it enables sequence specific knockdown of a target gene. Indications, such as age-related ma

Biopharmaceuticals is currently one of the fastest growing segments in the pharmaceutical industry. They have a vital use in the treatment of chronic diseases and also result in high profit margins for the drug developers. There are several therapeutic areas for which biopharmaceuticals are being investigated; these include oncology, metabolic disorders, viral infections, genetic disorders and immunological disorders. Biotherapeutics (both approved and under investigation) include monoclonal ant

Cancer is an extremely complex disease and medical science is still struggling to figure out the reasons and factors influencing the disease origin, propagation, spread (metastasis) and relapse. In addition to satisfying the unmet market need for advanced and efficient treatment interventions, cancer prevention, early detection and management is extremely important. The high cancer mortality rate is primarily due to delay in detection of the disease.Early diagnosis and screening makes it possibl

WHO has stated that the number of new cancer cases is expected to rise by 70% in the coming two decades. In the US alone, over one million people are diagnosed with cancer each year. Although cancer therapeutics continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. Specifically, immuno-oncology has been gradually nurtured by researchers over the last several years. Post an evident shift towards the development of therapeutics targetin

NASH or Non-Alcoholic Steatohepatitis refers to a chronic liver disorder characterized by accretion of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. In other words, it can be defined as significant steatohepatitis not caused due to alcohol, drugs, toxins, infectious agents or other identifiable exogenous causes. NASH is often accompanied with a high possibility of cirrhosis, a condition in which the liver functions are changed, leading to liver insufficiency. Alt

Advances in genetic engineering and cloning techniques have allowed isolation and expression of heterologous and recombinant proteins for research, therapeutic and industrial uses. Large scale applications such as enzyme, antibody or vaccine production require high amounts of protein. This demands that the system producing protein must be easy to culture, allow rapid cell growth and provide good yield. Various expression systems based on the machinery of bacteria, yeast, insect or mammalian cell

Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment.Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering pric

Cancer is known to be one of the leading causes of death worldwide. The field of oncology is vast and comprises several indications, including some rare / orphan forms. Although oncology continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. The focus of drug developers is gradually moving towards immunotherapeutics, which make use of the body’s own immune system or its components to fight cancer. It is a relatively new concept,

The problem of counterfeit products has been a common challenge to all the industries across the globe. However, when it comes to the pharmaceutical industry, the issue primarily revolves around the health of patients rather than revenue losses in the industry. Counterfeit drugs create substantial public health hazards and cause crucial safety concerns. Falsified or substandard drugs can lead to adverse reactions / side effects and consequently lead to the death of a patient. The major challe

Injectable drug delivery systems have traversed a long way from conventional syringes with vials to prefilled syringes, auto-injectors, pen injectors and needle free systems. These modern devices have become preferred devices for parenteral administration of drugs, mainly used for treatment of chronic conditions requiring patients to self-administer medication several times a week. The origins of prefilled syringes can be traced back to early 1980s when Sanofi and Rhone Poulenc-Rorer (Sanofi-

The concept of growing tissues outside their natural system in an artificially created microenvironment is known as tissue culturing. It is a common tool for developing model systems that are useful for studying the basic human molecular and cell biology metabolisms. Cell culturing was first initiated in flat plastic or glass dishes as 2D cell culturing. Since then, all the tissue engineering, stem cell, molecular biology work is being carried out on the widely popular petri dishes. However, the

Given the intricacy of the anatomy and physiology of the eye, it is quite challenging to deliver an ophthalmic drug effectively to a specific ocular site. Several barriers have to be overcome for a successful ocular drug delivery. These include dilution of a drug by tears, clearance of a drug by the lymphatic system of conjunctiva and drug permeation issues with respect to the cornea, sclera and choroid. Approximately 95% of the drug, in topical eye drops, is lost due to the aforementioned barri

View Latest Edition Several people across the globe suffer from different neurological disorders. However, the drugs currently available in the market provide only symptomatic relief and do not treat the root cause. This is because of their inability to penetrate across the blood brain barrier (BBB). BBB is a highly selective permeable membrane which allows the entry of only specific molecules, across it, into the brain. The widening gap between the demand of effective treatments and supply o

Characterized by a rapidly expanding product pipeline and a capital intensive manufacturing business, the biopharmaceutical market is witnessing a growing trend towards contract manufacturing. In addition to serving as a cost-cutting tool, contract manufacturing provides several other advantages to biopharmaceutical companies including technical expertise, operational efficiency, regulatory support and the ability to focus on core competencies.Spanning multiple operations withinthe wider manufac