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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

Enabling Total Biopharma Solutions

Pall Life Sciences

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

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

Monica Cardona and Ian Johnson Pall Life Sciences

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

Efzimfotase alfa misses statistical significance on primary walking endpoint but improves fatigue in adolescents and adults with hypophosphatasia in HICKORY Phase III trial


Abbott’s Cologuard screening linked to fewer colorectal cancer cases and lower risk of death in new real world data


Teva’s ecopipam shows rapid and sustained tic reduction in children with Tourette syndrome in new data presented at MDS 2026


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Upcoming Webinars

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Past Webinars

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


Continuous Manufacturing: Business Case Drivers and Deployment Strategies

Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Group
26th February 2019


Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

Presented by Miriam Guest, New Modalities & Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK and Ulrich Herber Senior Director of Technology and Market Development at Charles River
12th January 2022


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