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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...

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JSR Life Sciences



Headline News

Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


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Past Webinars

Digital Transformation Strategy Development in Biologics Manufacturing: One site’s journey

Presented by Robert Dimitri, Associate Director, Digital and Data Sciences Lead at Takeda and Toni Manzano, PhD, Chief Science Officer, Bigfinite
01st October 2020


Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing

Presented by Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen and David Gemmell Senior Process Engineer at Merck
17th October 2019


Establishing Early Development Strategies For Therapeutics Proteins

Presented by Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis and Bernardo Cordovez, PhD, Chief Science Officer & Founder, Halo Labs
21st October 2020


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