Current Issue

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

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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER  

Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing

Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.

Cleanability and Re-Usability of Cadence™ Inline Diafiltration Modules

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Headline News

Lilly’s Foundayo at 17.2 mg outperforms 25 mg oral semaglutide on weight loss and A1C reduction, new indirect treatment comparison finds


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


Pfizer to showcase new cancer research spanning current standards of care and emerging pipeline breakthroughs at ESMO 2026


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Upcoming Webinars

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Past Webinars

From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
27th March 2019


Challenges and Risks in Development and Manufacture of Covid 19 Vaccines

Presented by Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac, Harish Rao, General Manager at Serum Institute of India Ltd, Amar Shrivastava, Senior Manager  at Serum Institute of India Ltd
30th June 2020


Development of automated chemometric platform for accelerated Raman-based model optimization in biologics

Presented by Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen and Followed by Brian Rohrback, President and CEO of Infometrix, Inc.
20th September 2021


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