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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

Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


Olomorasib shows durable first-line activity in KRAS G12C-mutant lung cancer


Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial


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Past Webinars

Safety Evaluation on Extractables and Leachable

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Tino Otte, Head of Sales & Consulting at Intertek
25th October 2022


Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services
24th September 2020


CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 2022


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