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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

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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

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


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


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Upcoming Webinars

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Past Webinars

Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Dr. Magali Roche, Sales Manager, PathoQuest, Biologics Genomic Service
16th October 2020


Case Study: CMC Biologics Explores the Potential of Continuous Multi-Column Chromatography

Presented by Michelle Najera, PhD, CMC Biologics, Downstream Process Development Scientist and Lynne Frick, Director of Sales, Continuous Bioprocessing, Pall Life Sciences
06th February 2017


Interface Machine Learning Process Analytical Technology and Process Science For Next Level Process Development.

Presented by Oliver Steinhof, Senior Scientist Process Analytical Technologies (PAT) at Biogen and Martin Gadsby, Owner, Optimal Industrial Technologies Ltd
05th April 2022


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