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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

Volume Reduction and Process Optimization with Cadence Inline Concentrator

Coupling single-pass TFF before loading onto a chromatography sorbent

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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


Roche receives CE Mark for compact cobas smart e immunoanalyser


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Upcoming Webinars

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Past Webinars

Janssen’s Real Time release: Using MSPC to enhance batch release.

Presented by Sarah Nielsen, Director of Process Science at Janssen and Herman He, Senior Applications Scientist at Thermo Fisher Scientific
15th September 2021


ICH Q3E Guidelines and Its Implications

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Dries Cardoen, Team Leader of Study Directors Inhalation/topical/transdermal products at Nelson Laboratories, LLC
22nd March 2021


The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
02nd September 2020


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