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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

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

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

Novel Synthetic Adsorptive Depth Filter Media for CHO Harvest Clarification

John Amara, Ph.D. and Michael Dullen Merck, 80 Ashby Road, Bedford, MA, 01730, USA

Bringing the Freezing of Biopharmaceuticals in From the Cold

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Headline News

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


Roche receives CE Mark for compact cobas smart e immunoanalyser


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


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Upcoming Webinars

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Past Webinars

Key components of a comprehensive program for the management of single use technologies in biologics manufacturing

Presented by John Maguire, Shire and Donald Young, ThermoFisher Scientific
18th July 2018


Just in Time Release of CAR T Cell Therapies During Covid-19

Presented by Irving Ford, Site QA Head multi-product CAR T facility at Bristol Myers Squibb and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
29th November 2021


Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020


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