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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

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

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

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Coupling single-pass TFF before loading onto a chromatography sorbent

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

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Headline News

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


Lilly highlights retatrutide, Taltz and Zepbound data across rheumatologic diseases and obesity


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Upcoming Webinars

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Past Webinars

Development and Implementation of Intensified Bioprocessing for Biologics Manufacturing

Presented by Hang Zhou, Ph.D., Vice President, Head of Cell Culture Process Development Biologics and Bioprocess Dept. at WuXi Biologics
12th March 2021


Case Study and Experience on Sanofi’s and SGS’s Implementation of BPOG’s Leachable Risk Assessment Model

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 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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