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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

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  

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

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Headline News

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


Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines


Shockwave Javelin IVL catheter shows positive results in pivotal FORWARD CAD study


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Upcoming Webinars

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Past Webinars

From Concept to Market – Unique approaches in Biomanufacturing

Presented by Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
18th September 2019


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


Characterization of Residual Impurities in Gene Therapy Drug Products

Presented by Jessica Townsend, Senior Manager Analytical Development at bluebird bio and Eric S. Bishop, Vice President of Research & Development at Cygnus Technologies
26th January 2023


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