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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


Featured Articles

Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities with Disposable Technologies

Gloria Gadea-Lopez, Ph.D. is Director of Production and Business Systems at the Shire Lexington, John Maguireis the Associate Director of Manufacturing Systems at Shire’s Lexington and Megan Rabideau is a Manufacturing Systems Engineer at Shire’s Lexington

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Taltz and Zepbound combination maintains improved psoriatic arthritis outcomes at one year


Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences


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Upcoming Webinars

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Past Webinars

Handling mutagenic extractable and leachable compounds released from devices

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs
10th February 2022


Can the New generation of perfusion technology compete or replace the conventional and widely preferred fed-batch technology?

Presented by Ankur Bhatnagar, Chief Scientific Manager of Biocon R&D
15th November 2017


Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020


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