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By Bikash Chatterjee, CEO, Pharmatech Associates | Two key innovations — continuous perfusion in upstream processing and multicolumn chromatography in downstream processing — are having a profound impact on biologics manufacturing. | |
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By Josh Erickson, USP | Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes. | |
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By Susan Shockey, Clarkston Consulting | The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7. | |
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