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

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

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

Bringing the Freezing of Biopharmaceuticals in From the Cold

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

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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Headline News

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


Camzyos shows sustained benefit through 56 weeks in paediatric obstructive HCM


Allergan Aesthetics reports improved facial satisfaction in GLP-1 users after aesthetic treatments


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Upcoming Webinars

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Past Webinars

Analytical Strategies for Comparability in Bioprocess Development

Presented by Dr Christine P. Chan, Director in Global Manufacturing Science & Technology at Sanofi
15th September 2020


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


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


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