Category: Contract Manufacturing

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,

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 / mRNA therapeutics. Safety, efficacy and rapid production of mRNA drives the interest in this domain. However, mRNA production is fraught with several challenges as

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,

Upon realizing the potential of digital biomanufacturing over traditional processes, players are actively undertaking initiatives to adopt advanced platforms to drive operational excellence, visibility, control and synchronization in bioprocessing. Industry 4.0: An amalgamation of physical equipment and smart software Digital biomanufacturing offers real-time process optimization based on factors, such as anticipated product quality and batch

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

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

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

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

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

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

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

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

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

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

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

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

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

The coronavirus outbreak and the drop in economy that we are facing today is unlike anything that most of us have seen in our lifetime. The pandemic has threatened the whole world to such an extent that life has come to a standstill. In fact, the initial stage of lockdown featured the fragile nature of

The ongoing COVID-19 crisis has put the pharmaceutical manufacturing supply chain under close scrutiny. The overdependence of the US on China and India to meet its API demand has been the talk of the town. However, with the number of infected cases in the US surpassing that of China, the focus has shifted from discussing

The interest in the trillions of human microbiome present in the human body has attracted a lot of research effort in the microbiome domain. The first such effort at a large scale was The Human Microbiome Project, conducted by the National Institutes of Health in the United States, which characterized the microbial communities at five

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

As per recent news coverage, United Therapeutics has received a permit for $9.5 million build-out of its cell therapy facility on the second floor of Mayo Clinic’s Discovery and Innovation Building. What is the area of the facility:  The facility will have a total of 21,843-square-foot space. What are the capabilities at the facility:  The facility will house

Cell and Gene Therapy CROs are the new entrants in the pharma Superstar Club. They are selling tickets faster than a Queen’s concert in the 1980s. In fact, as per the Alliance of Regenerative Medicine’s recent findings, there has been more than 75% year on year increment in funding to support the development of various cell and gene

The global vaccine manufacturing market is anticipated to generate revenues worth USD 100 billion by 2025. According to the WHO, the global vaccination rate is nearly 85%, demonstrating the high clinical demand for vaccines. In addition to meeting the growing demand for vaccines, the developers of these pharmacological interventions are also plagued by high costs