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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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Navigating Technology Transfer

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

FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


Astellas begins Phase III trial of setidegrasib in KRAS G12D mutated advanced lung cancer


Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


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Upcoming Webinars

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Past Webinars

Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century

Presented by Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and  Dr. David Jones, Director of New Products & Industry Affairs at Rapid Micro Biosystems
12th September 2019


From Product Characterization to Clinical Reliable Specifications

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


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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