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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

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

Pall Corporation

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Headline News

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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


FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks


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Upcoming Webinars

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Past Webinars

Host Cell Protein Characterisation and Mass Spectrometry Strategies

Presented by Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR
19th February 2019


Real Time Monitoring of Bioprocess and Beyond – A Process Analytical Perspective

Presented by Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb and Julia Ding, Head, Global Process Analytical Development at Bristol Myers Squibb and Eric Carlson, Ph.D., President & CEO, Protein Metrics Inc.
16th November 2020


Current Progress in Approaches for The Safety Assessment of Extractables and Leachables

Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services
06th April 2018


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