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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



Headline News

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


Roche receives CE Mark for compact cobas smart e immunoanalyser


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Upcoming Webinars

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Past Webinars

Extractables from Single-Use Bioreactors/Bags and Impact on Cell Culture Performance

Presented by Yasser Nashed-Samuel, Principal Scientist at Amgen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
22nd January 2019


How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
19th September 2019


Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

Presented by Dr. Jimmy Li, CEO of WuXi XDC (a WuXi Biologics subsidiary)
23rd February 2022


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