Current Issue

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

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

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

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

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


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


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


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Upcoming Webinars

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Past Webinars

Single Use Process for Production of AAV Gene Therapy Products

Presented by Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics, Vikas Gupta, Vice President and GM Downstream Bioprocessing and Gene Therapy, Rachel Legmann, Senior Director of Technology, Gene Therapy at Repligen and Gilbert Huang, Senior Field Application Scientist at Repligen
26th May 2022


Monitoring Impurities in Biologics

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 
26th November 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


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