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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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

Coupling single-pass TFF before loading onto a chromatography sorbent

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


Lilly’s Foundayo at 17.2 mg outperforms 25 mg oral semaglutide on weight loss and A1C reduction, new indirect treatment comparison finds


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Upcoming Webinars

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Past Webinars

Modernizing Biopharmaceutical Manufacturing: from Batch to Continuous Production

Presented by Robert Dream, PE, CPIP, of HDR Company, LLC
19th July 2017


Continuous Manufacturing of Biologics: A Journey from Concept to Reality

Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
15th September 2021


High-Resolution Optical and Dielectric Methods Monitoring Cells in Bioprocesses

Presented by Michael Butler, PhD, Professor and Principal Investigator, National Institute for Bioprocessing Research and Training (NIBRT)
19th October 2020


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