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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

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

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

Navigating Technology Transfer

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

Coupling single-pass TFF before loading onto a chromatography sorbent

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


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Upcoming Webinars

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Past Webinars

Designer Sterile Filtration in Aseptic Processing Using Single Use Technology

Presented by Alan Kelly, Project Engineer at Sanofi and Terri Love, Senior BioManufacturing at Merck
10th November 2020


Annex 1 and Environmental Monitoring Program – Implementation And Justification of The Best Practices In Routine

Presented by Presented by Benoit Ramond, Head of Microbiology & Sterile Technology at Sanofi and Laurent Leblanc, 3P Ecosytem R&D Manager at bioMérieux
19th October 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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