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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

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

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

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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Headline News

Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


Olomorasib shows durable first-line activity in KRAS G12C-mutant lung cancer


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Upcoming Webinars

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Past Webinars

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


Mapping Future Technology Needs For Real Time Release Testing

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


PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche
03rd May 2019


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