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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

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

Changing Column Packing from an Art into a Science

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

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Headline News

Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


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Upcoming Webinars

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Past Webinars

Use of Computational Modelling in Specification Setting and Establishing Control Strategy

Presented by Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd
15th July 2019


DSF and FTIR as complementary methods for the identification and characterization of vaccine products

Presented by Marina Kirkitadze, Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur and Rina Dukor, President, BioTools
18th September 2018


New Drying Processes for Biopharmaceuticals

Presented by Sune Klint Andersen, Principal Scientist at Janssen Pharmaceutical Companies of Johnson & Johnson and Lars Markwort co-founder and CEO of Bioinicia SL
05th May 2020


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