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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

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

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

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

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022


Material Requirements to Support Gene Therapy Development

Presented by Clare Blue, Director of Analytical Development at Biogen and James Wilkinson, VP of Sales and Customer Success at Refeyn
19th May 2022


Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020


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