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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

Changing Column Packing from an Art into a Science

Accelerating the Commercialization of Biosimilar Medicines in India

Sartorius Stedim Biotech

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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

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Headline News

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


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


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


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Upcoming Webinars

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Past Webinars

Transformation of Toxicology data into Specific PDE’s

Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 2020


Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing within Industry 4.0

Presented by Robert Guenard, Senior Director - Manufacturing Sciences at Biogen, Petter Moree, Global Industry Principal at OSIsoft and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
13th November 2020


Towards Real Time Release testing: Dissolution prediction of tablets made using Continuous Direct Compression

Presented by Pallavi Pawar of GlaxoSmithKline
21st November 2017


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