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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

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

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

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

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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

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Headline News

Taltz and Zepbound combination maintains improved psoriatic arthritis outcomes at one year


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

Harmonized Manufacturing Network For Sterility Assurance

Presented by Frederic Ayers, Advisor, Global Quality Systems at Eli Lilly and Company
06th February 2023


Changing the Paradigm: Moving to In-Process Release Testing

Presented by Presented by Scott Weiss, Director, Industrial Microbiology at Johnson & Johnson and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
05th February 2021


Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology

Presented by Dr. Zlatibor Velickovic PhD Production Manager | Department of Cell & Molecular Therapies, Royal Prince Alfred Hospital Sydney, Australia, ISCT Regional Vice-President Elect, Australia & New Zealand and Alan Hoffmeister Senior Global Technology & Market Development Manager, Charles River Laboratories
28th October 2021


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