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

Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release

By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer

Comparison of purification performance of Amsphere A3 to other commercially available Protein A resins

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

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

Bristol Myers Squibb adopts positive CHMP opinion for Opdivo plus Yervoy for patients with Microsatellite instability high or mismatch repair deficient metastatic colorectal cancer

Bristol Myers Squibb

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Headline News

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


Livdelzi improves ALP normalisation rates in Phase III PBC study


Nipocalimab Sjögren’s data highlight symptom improvements most valued by patients


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Upcoming Webinars

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Past Webinars

Creation of a real time process data framework with external manufacturer to enhance process performance, technology transfer success and drive cost savings

Presented by Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader at The Janssen Pharmaceutical Companies of Johnson & Johnson
08th February 2023


Material Requirements to Support Gene Therapy Development

Presented by Clare Blue, Director of Analytical Development at Biogen and James Wilkinson, VP of Sales and Customer Success at Refeyn
19th May 2022


Future Trends To Control Risks From Extractables and Leachables

Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe
09th February 2021


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