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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


Featured Articles

Navigating Technology Transfer

A SMART Platform for Scalable Biotherapeutic Development: cDNA to 200L Single-Use Stirred-Tank Bioreactor

Coupling single-pass TFF before loading onto a chromatography sorbent

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

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Headline News

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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


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Upcoming Webinars

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Past Webinars

Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies in Pharmaceutical Development

Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc.
01st July 2019


Best Practices of Downstream Protein Purification and Product Concentration

Presented by Krishnamurthy Venkatesan, Downstream MSAT Lead, Director at Biocon Biologics, Sofie Östemar, Product Manager for Connected & Continuous Downstream Processing and Henrik Ihre, Ph.D. Director Strategic Technologies at Cytiva and Nigel Jackson Principal Engineer, Bioprocessing R&D at Pall Corporation
12th October 2022


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


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