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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

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER

Continuous processing optimization with smarter tools

Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific

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Headline News

FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial

RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer

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Upcoming Webinars

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Past Webinars

Material Understanding for Continuous Manufacturing of Solid Dosage Forms

Presented by Dr Yifan Wang, Regulatory Research Scientist, FDA CDER and Dirk Leister, Leader Technical Marketing Thermo Fisher Scientific
23rd August 2018

Single Use Systems in Biologics Manufacturing and their Impact on Operational Technology

Presented by Gloria Gadea-Lopez, PhD, John Maguire & Mark Maselli of Shire followed by Ken Clapp of GE Healthcare
04th April 2017

End User Perspective on Setting in-Process Endotoxin Limits

Presented by Dr Friedrich von Wintzingerode, Roche/Genentech
15th May 2018

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Featured Companies

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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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