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Articles by Harlan Knapp
Ensuring Data Integrity in BioPharmaceutical Manufacturing: The Need for Contextualization and Cloud-based Integration Original
Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the importance of the accuracy and reliability of data across supply chains. Yet, the difficulty of achieving this milestone can still be underestimated by drug sponsors, especially when working with manufacturing partners.
04.22.22 -- FDA Issues Guidance On Initiation Of Voluntary Recalls
Article | By Joe Makowiecki and Harlan Knapp, Cytiva Unlocking the full potential of viral vector-based therapies requires an understanding of existing challenges in viral vector production and what technologies are now available to help address them. Article | By Harry Benson, CAI Companies often seek help in closing open investigations, but they ignore the source of these, even while product sits quarantined. Where clients really need help is in cutting human error off at the source.
04.21.22 -- Best Practices Working With CDMOs
Newsletter | April 21, 2022 By Pharmaceutical Online In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. This e-book gives advice to established as well as emerging pharma companies on working with your CDMO on topics such as CMC support, quality assurance, risk assessment, and shared qualification audits, and it also provides tips to facilitate trust and to further the relationship.
06.07.21 -- Implementing Small-Scale Models For Biopharma Development
By J. Buyel and K. Kaiser (Bayer AG), K. Andra (Alexion), R. Luo (GlaxoSmithKline R&D), A. Henry (Biogen), C. Leveder (Sanofi R&D), M. Richards (Eisai Inc.), T. Connolly (BioPhorum Development Group) This article from a BioPhorum Development Group discusses the applications of small-scale models, including viral clearance, quality oversight, and design considerations. By Matthew Pillar, editor, Bioprocess Online Rezolute Inc.
05.27.21 -- Small Molecule Drug Substance Outsourcing
By ISR Reports In Q4 2020, ISR asked 123 outsourcers of small molecule API about the proportion of manufacturing allocated across three different approaches to outsourcing: tactical outsourcing, preferred providers, and strategic partnerships. The data show that the largest proportion of work is allocated tactically (38%), but that is expected to shift to preferred providers (41%) over the next three years as more outsourcing companies establish preferred relationships. By S. D.
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