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.
The China Industry Research Institute projected that that China's biological therapeutics market could reach 300 billion yuan (~US$50 billion) in 2019. Government investment in bioindustrial hubs will add >$300 billion to the Chinese biological industry by 2020.
Part 2 of this series on single-use systems in manufacturing cell and gene therapies provides a regulatory overview. It is based largely on experience from blood processing and biologics manufacturing.
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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Key considerations for the design of oligonucleotide characterization programs and relevant analytical approaches with case studies using mass spectrometry and ion-pair HPLC are discussed.
