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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

Ubamatamab produces high rate of durable responses in early study of advanced low grade serous ovarian cancer


FDA review of Novo Nordisk’s denecimig for haemophilia A runs longer as manufacturing facility remediation continues


Sanofi and Regeneron bring four new long acting antibodies into Dupixent partnership in deal worth up to $8 billion


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Past Webinars

Janssen’s Real Time release: Using MSPC to enhance batch release.

Presented by Sarah Nielsen, Director of Process Science at Janssen and Herman He, Senior Applications Scientist at Thermo Fisher Scientific
15th September 2021


ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics.

Presented by Jason Creasey, Managing Director at Maven E&L Ltd, Piet Christiaens, PhD, Scientific Director and Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director at Nelson Labs
14th September 2022


Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes

Presented by Dan Hill, Manufacturing Scientist at Biogen and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
03rd June 2020


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