A recent CDMO press release essentially asserted superiority via proximity: Geography as God of outsourcing. I contacted two biopharma executives familiar with the Boston/Cambridge scene for reactions: Michael Kaufman, Senior Vice President, CMC, Mersana Therapeutics, and 15-year veteran of Merck; and George Avgerinos, Senior Vice President of Biologics Operations, Fortress Biotechnologies, and 22-year veteran of BASF/Abbott/Abbvie.
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Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
Process characterization is an important step in the overall journey of product development. In this poster, scientists at propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.
Shortening timelines to generate more productive, stable and high expressing cell lines is the goal of any cell line development program. This technical poster details the methodologies and clonal variation of combining a cell line development technology with a platform for clonal cell line selection.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Three cell and gene therapy sector SMEs representing industry and academia explain supply chain challenges and viable solutions.
Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the sixth in a six-part series on how single-use systems (SUS) are changing the modern biotechnology facility design and construction paradigm.
Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.