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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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

Overcoming Obstacles in AAV Viral Vector Manufacturing

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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Taltz and Zepbound combination maintains improved psoriatic arthritis outcomes at one year


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


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Past Webinars

Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022


Continuous Manufacturing of Biologics: A Journey from Concept to Reality

Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
15th September 2021


The Business Benefits of PAT in Continuous Drug Product Manufacturing

Presented by Steve Hammond, Independent Consultant at Steve Hammond Consulting
22nd September 2021


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