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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

Navigating Technology Transfer

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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER

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

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Headline News

Roche launches VENTANA BAP1 test to support mesothelioma diagnosis

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial

FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold

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Upcoming Webinars

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Past Webinars

Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release

Presented by John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River
08th November 2018

Manufacturing in the Industry 4.0 era: how to balance innovation with performance while not being disrupted

Presented by Christos Varsakelis, Senior Manager Global Analytics and Innovation, GlaxoSmithKline Biologicals SA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Roger-Marc Nicoud, President & CEO Ypso-Facto
10th March 2021

Extractables and Leachables Testing Using a Quality Risk Management Approach

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer and Dr. Dennis Jenke, Principal Consultant for Nelson Labs
09th September 2020

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Featured Video

At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.

There’s no kit for the perfect biotech process. Until now.

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