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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...

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Featured Articles

Bringing the Freezing of Biopharmaceuticals in From the Cold

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Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Overcoming Obstacles in AAV Viral Vector Manufacturing

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

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Headline News

AstraZeneca commits $2 billion to Summit Therapeutics as part of new equity stake and cancer research alliance centered on antibody drug conjugate combinations


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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Past Webinars

We Are Going Back to the Future with Rapid Methods.

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux
14th February 2022


Janssen CM-strategy: A Story of Multiple Platforms From R&D to Commercial

Presented by Jeroen Geens, Engineering Technical Director at Janssen Research & Development and Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen + Verfahren GmbH
03rd December 2020


From Product Characterization to Clinical Reliable Specifications

Presented by André Mischo, Associate Director Science & Technology at Novartis
11th May 2022


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