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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


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Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

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Headline News

Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

Handling mutagenic extractable and leachable compounds released from devices

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs
10th February 2022


New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany
09th April 2019


Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA
22nd October 2020


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