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

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

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor

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Headline News

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


Lilly and Hims & Hers expand access to Zepbound and Foundayo


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


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Upcoming Webinars

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Past Webinars

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


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


Rapid Microbiology Applications in the COVID-19 Era

Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020


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