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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

Amsphere A3

JSR Life Sciences


Featured Articles

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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Headline News

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

End User Perspective on Setting in-Process Endotoxin Limits

Presented by Dr Friedrich von Wintzingerode, Roche/Genentech
15th May 2018


Affinity Chromatography for Vaccines Purification

Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
12th May 2020


Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release

Presented by John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River
08th November 2018


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