BioPharm International
November 01, 2017
Regulatory Beat
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Reliable, high-quality products require innovative analytics and production.
November 01, 2017
Ask the Expert
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Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
November 01, 2017
Features
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This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
November 01, 2016
Features
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New data analytics tools help solve complex problems in a biotherapeutic development process.
November 01, 2016
Features
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In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
November 01, 2016
Cover Story
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Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
November 01, 2016
Peer-Reviewed Research
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To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
November 01, 2016
Perspectives on Outsourcing
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CMO executives are focusing on M&A activity, new business models, and fundraising limits.
November 01, 2016
Features
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The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.
November 01, 2016
Supply Chain
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Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
November 01, 2016
Features
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Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.
November 01, 2016
Issue PDF
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Click the title above to open the BioPharm International November 2016 issue in an interactive PDF format.