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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

Coupling single-pass TFF before loading onto a chromatography sorbent

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

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

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

Navigating Technology Transfer

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Headline News

mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults


Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


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Upcoming Webinars

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Past Webinars

The Importance of Accurate Chemical Characterization of Medical Devices Extractables

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christiaens, PhD, Scientific Director at Nelson Labs
16th November 2022


Establishing Early Development Strategies For Therapeutics Proteins

Presented by Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis and Bernardo Cordovez, PhD, Chief Science Officer & Founder, Halo Labs
21st October 2020


An impurity detected in a stability study: Did we miss anything in our E&L risk assessment?

Presented by Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe
15th March 2022


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