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| Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon | As the U.S. government works to pass the BIOSECURE Act, which aims to the protect the IP of U.S. pharma companies, the EU is simultaneously seeking to increase innovation across the European biomanufacturing industry. Amid these cultural shifts, sponsors are considering the best global partnerships for their goals. |
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By Yi Yang, Ph.D., Genentech | Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization. |
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By Yadnyesh Patel, microbiology subject matter expert | The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices. |
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By Samantha Atkinson, executive vice president and principal consultant, NSF | It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity. |
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| Process Validation Considerations | Article | MilliporeSigma | Process validation is a crucial step for successful registration and commercial manufacturing. Learn how to determine the right timing and properly apply a risk-based approach. |
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