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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

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

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

Navigating Technology Transfer

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

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

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Headline News

TAK-881 matches HYQVIA exposure while reducing infusion volume in Phase II/III PID study


ENTYVIO treat-to-target strategy reduces ulcerative colitis complication risk in Phase IV VERDICT trial


Roche highlights divarasib, giredestrant and Tam-Peli data ahead of ESMO 2026


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Upcoming Webinars

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Past Webinars

Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics

Presented by Ken Green, Ph.D, Head of Manufacturing, Science and Technology at Samsung Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
26th October 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


Shortages of critical raw materials and managing changes and substitutions

Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022


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