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Biopharmaceuticals have transformed the patient care landscape, but alongside this step change in treatment capability comes the need for a similar paradigm shift in manufacturing capability. Here, Maik W Jornitz, President & CEO of G-CON Manufacturing Inc. highlights how cleanroom infrastructure must develop to keep pace with ever evolving industry needs.
In this article, Charles River Associates (CRA) delves into why traditional vaccine procurement schemes are not fit for purpose during the pandemic and how both governments and manufacturers must adapt to manage the greater level of risk associated with pandemic vaccine development and distribution.
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
Plasma-derived therapies and medicines provide life-changing treatments for patients around the world who suffer from serious, and often rare, diseases that affect the immune system or result from non-functioning proteins in blood plasma. Carole Resman, Executive Vice President Production at LFB, describes the complex and highly regulated manufacturing process of…
Featured in this in-depth focus, articles exploring why cleanroom infrastructure must transform to meet the needs of the cell and gene therapy industry and discussing a novel platform for discovering and developing genetically-targeted therapies for autoimmune diseases.
European Pharmaceutical Review's latest journal features articles discussing the challenges and potential of antibody-drug conjugates, innovations in cleanroom infrastructure and why we need to test for heavy metal contaminants in cannabis vaping aerosols. Also in the issue, an exploration of how risk-sharing strategies could help expedite access to COVID-19 vaccines,…
Research suggests the increasing R&D investment in and adoption of biologics will drive growth in the global biologics contract development and manufacturing organisation (CDMO) market.
A report indicates ongoing demand for COVID-19 vaccines and other biologics, as well as increasing investment will drive a 16.6 percent CAGR in the bioreactors market.
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
The emergence of CAR T-cell therapies has ignited a revolution in the field of cancer treatments. While existing products show outstanding curative capability, they are hampered by significant clinical and commercial challenges, many of which stem from their manufacturing process. Maciej Nakoniecznik discusses how a combination of biological and technological advances…
In this in-depth focus, discover how biological and technological advances could enhance the clinical capabilities of CAR T-cell therapies and explore why clinicians need to be better educated about the development and licencing of biosimilars.
In this issue we discuss whether clinicians know enough about the development of biosimilars to buy in, explore the biggest M&A trends in pharma and what to expect this year and consider the importance of disaccharides in the stabilisation of biologics. The journal also features articles on the fundamentals of…
The UK Government has ordered a further 40 million doses of Valneva’s COVID-19 vaccine candidate, to be manufactured in Scotland.
Researchers have developed a novel high-throughput method for the detection of glycans in purified biopharmaceutical samples. In this article, Victoria Smith, Lewis Wharram and Stuart Jamieson discuss their innovative approach and the implications for safety and potency assurance in biopharmaceuticals.
In this in-depth focus learn about the development and implications of a novel high-throughput method for glycoanalytics and how taking a full-ecosystem approach to microbiome restoration could improve patient survival.
