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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 

Continuous processing optimization with smarter tools

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

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

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

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Headline News

mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


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Upcoming Webinars

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Past Webinars

Mapping Future Technology Needs For Real Time Release Testing

Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb
09th August 2019


Extractable Study Design and Data Evaluation of Polymeric Product Contact Materials

Presented by Dr. Ping Wang, Principal Scientist, Janssen R&D and Dr Nixdorf, SGS Group
05th June 2018


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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