The BPI editors review some state-of-the-art alternatives in upstream and downstream monoclonal antibodies for drug substance bioprocessing as well as drug-product manufacturing.
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This four-part educational series highlights key trends emerging in China biopharmaceuticals, using select content from BioPlan Associates’ 2018 report on the biopharmaceutical industry in China.
Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods.
Opportunities abound for the rest of the developed world’s biologics developers, manufacturers, suppliers, distributors, and regulators to participate in the growth of China’s biologics industry.
This article is designed to provide guidance on cell and gene therapy (CGT) manufacturing processes, regulations, and best practices regarding implementation of single-use polymeric components.
In the next few years, our industry is likely to see more applications of robotic systems, particularly mobile and collaborative robots in warehouse and production floors of biomanufacturing facilities.
Cell and gene therapy development presents significant data challenges. This article presents a CFR Part 11 compliant data management system project that Skyland Analytics and bluebird bio have undertaken.
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Horizon’s GS-KO CHO SOURCE cell line is available with an unlimited use license, and the company allows for and actively encourages cell-line modifications to improve biomanufacturing performance.
