Outsourcing and Insourcing: Considerations for Biopharmaceutical Testing
A Note from the Editor
Dear Reader,
Welcome to this special supplemental issue of American Pharmaceutical Review targeting considerations for biopharmaceutical testing. In this supplement, we present a range of articles focused on the various aspects of testing biopharmaceutical products. Viral contamination is a major concern in biologics, and Dr. Kate Bergmann presents a novel means of combating viral contamination in her article on viral inactivation via UV-C irradiation. During storage, biologics can be subjected to contamination by various container leachables, as Dr. Charles Ducker outlines, and he presents a comparison of extractable profiles from several common single-use bioprocess containers. Dr. Jon Kauffman illustrates many key considerations for the careful selection of an external partner when outsourcing biologics stability studies. We also present a look at potency testing in biopharmaceuticals from Dr. Weihong Wang, who discusses reducing patient and business risk via appropriate method development and validation strategies. This issue also contains an interview with Dr. Jeri Ann Boose on cell banking, and a brief article on insourcing and scientific staffing challenges from Beth DiPaolo. We hope you find the insights and expertise contained in this supplement especially useful to you in your biopharmaceutical testing needs.
As always, thanks for reading.
John E. Essex III Editor-in-Chief
jessex@comparenetworks.com
Contents
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The Risks of Single-Use Bioprocess Containers ................................................1 Outsourcing Biologics Stability Programs: Points to Consider ...........................5 Potency Testing of Biopharmaceutical Products ..............................................8 UV-C Irradiation: A New Viral Inactivation Method for Biopharmaceuticals .....12 An Interview with Dr. Jeri Ann Boose ............................................................14 Scientific Staffing Footprint Gains Global Traction .........................................16
IFC American Pharmaceutical Review | Biopharmaceutical Supplement 2014
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