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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

Continuous processing optimization with smarter tools

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

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

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

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Headline News

Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


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Upcoming Webinars

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Past Webinars

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


Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River
07th October 2019


Points to consider when defining a microbial control strategy for individualized ATMPs

Presented by Friedrich von Wintzingerode, PhD, QC Lead iNeST Project (individualized Neoantigen Specific Therapy)
05th April 2023


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