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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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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Headline News

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


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Upcoming Webinars

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Past Webinars

The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability through Small Footprint, Modular Equipment Trains

Presented by Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc.
10th October 2017


Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020


Regulatory Strategies and Case Studies 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
23rd May 2019


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