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By Matthew Pillar, Editor, Bioprocess Online
| Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, and even process development personnel turnover place analytical decisions made early on under a microscope. |
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By Vaibhav Patel, University of Minnesota | The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations and strategies for mitigating their presence in pharmaceuticals. |
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By Ioanna Deni, Bioplan Associates Inc. | BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area. |
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