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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

Navigating Technology Transfer

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

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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

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Headline News

Alexion strengthens research leadership in gMG care with new data at 2026 AANEM Annual Meeting and MGFA Scientific Session


FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications


Novo Nordisk secures exclusive global license from Hengrui Pharma for once-weekly oral GLP-1/GIP dual agonist HRS-1596


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Upcoming Webinars

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Past Webinars

Integrity Assurance for Single-Use Systems: End-User Perspective

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
14th March 2019


BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
05th March 2019


Engineering First Principles: Applications to Pharmaceutical Manufacturing

Presented by Bernard McGarvey, PhD Chemical Engineering
05th November 2019


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