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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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

Navigating Technology Transfer

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Headline News

FDA approves Enspryng as first at-home subcutaneous treatment for thyroid eye disease


SKYRIZI shows strong endoscopic outcomes in Phase III Crohn’s disease study


CHMP backs extended Libtayo dosing schedule across approved EU cancer indications


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Upcoming Webinars

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Past Webinars

Innovative solutions from Industry 4.0

Presented by Michael May, PhD, President and CEO, CCRM at Centre For Commercialization Of Regenerative Medicine and Philip G. Vanek, PhD, General Manager, Cell and Gene Therapy Strategy at GE
10th June 2019


Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up

Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
10th March 2020


Reducing Microbiological Risk and Using Quality Tools in the Pharmaceutical Industry

Presented by Don Singer Manager, Steriles Microbiology, for GlaxoSmithKline R&D and Jessica Rayser, Product Manager at Charles River
09th January 2019


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