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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

Navigating Technology Transfer

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

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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Headline News

FDA approves Lilly’s once weekly Onswik insulin for adults with type 2 diabetes


Körber certifies ZETA’s INOSIM Foresight for PAS X MES data integration


Trixeo approved in the EU as first triple combination maintenance therapy for asthma in patients aged 12 and older


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Upcoming Webinars

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Past Webinars

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


Extractables and leachables testing using a Quality Risk Management approach

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer and Satish Kumar Mohanvelu, Life Sciences Management Professional at MilliporeSigma
17th October 2018


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


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