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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...

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JSR Life Sciences


Featured Articles

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

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Headline News

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


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Upcoming Webinars

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Past Webinars

Do Extractable Protocols Truly Help – An End User Perspective

Presented by Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA, Darmstadt Germany
08th May 2019


Chromatography Based Near-Real-Time Measurements & Timely Control of Product Titer, Product Quality and Cell Culture Nutrients

Presented by Letha Chemmalil, Scientific Associate Director at Bristol Myers Squibb
23rd February 2023


Subvisible Particle Identification & Characterisation by Multi-Technique Methods

Presented by Dr. Jonas Hoeg Thygesen, Novo Nordisk Pharmatech. Followed by Colin Merrifield, ProteinSimple
23rd February 2017


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