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

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.

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

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

Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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


FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


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Upcoming Webinars

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Past Webinars

Transformation of Toxicology data into Specific PDE’s

Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 2020


Affinity Chromatography for Vaccines Purification

Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
12th May 2020


Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption

Presented by Presenter: James Hathcock, Ph.D., Moderator: Hélène Pora, Ph.D.
29th June 2017


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