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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

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

Enabling Total Biopharma Solutions

Pall Life Sciences

Overcoming Obstacles in AAV Viral Vector Manufacturing

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Headline News

Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


Astellas begins Phase III trial of setidegrasib in KRAS G12D mutated advanced lung cancer


Lilly’s Foundayo at 17.2 mg outperforms 25 mg oral semaglutide on weight loss and A1C reduction, new indirect treatment comparison finds


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Upcoming Webinars

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Past Webinars

In Depth Characterization with Mass Spectrometry and Orthogonal Methods of Conformers in a Trispecific HIV Antibody

Presented by Bruno Genet, Lab head Structural Analysis MS at Sanofi
18th November 2020


Current Progress in Approaches for The Safety Assessment of Extractables and Leachables

Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services
06th April 2018


Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


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