Current Issue

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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Changing Column Packing from an Art into a Science

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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


Viatris agrees to acquire Pacira BioSciences for $1.65 billion to add Exparel and Zilretta


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

Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing

Presented by Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen and David Gemmell Senior Process Engineer at Merck
17th October 2019


Characterization of Residual Impurities in Gene Therapy Drug Products

Presented by Jessica Townsend, Senior Manager Analytical Development at bluebird bio and Eric S. Bishop, Vice President of Research & Development at Cygnus Technologies
26th January 2023


Shortages of critical raw materials and managing changes and substitutions

Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022


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