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

Best Practices For Successful Filter Integrity Testing Using Water Intrusion Test (WIT) Method

Monica Cardona and Ian Johnson Pall Life Sciences

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

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.

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Headline News

Roche receives CE Mark for compact cobas smart e immunoanalyser


FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


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Upcoming Webinars

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Past Webinars

Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process

Presented by Oliver Steinhof, PAT Scientist at Biogen and Martin Gadsby, Owner, Optimal Industrial Automation Ltd
06th November 2020


Preview of USP’s Informational Chapter <1085>, “Guidelines on the Endotoxins Test”

Presented by Karen Zink McCullough & Kevin L. Williams
11th June 2018


Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen and Kevin L. Williams, Microbiological Test Development at bioMérieux
28th September 2020


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