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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

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

Navigating Technology Transfer

Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)

Pall Corporation

Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection

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Headline News

EMPAVELI reduces proteinuria and stabilises kidney function in adolescents with C3G or primary IC MPGN


Perioperative Imfinzi combined with neoadjuvant enfortumab vedotin secures Priority Review status in the US for muscle-invasive bladder cancer patients


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


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Upcoming Webinars

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Past Webinars

Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Veronika Wills, Manager, Technical Services
24th September 2020


Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

Presented by Petra Booij, Investigator at GlaxoSmithKline and Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific
30th January 2020


The Importance of Accurate Chemical Characterization of Medical Devices Extractables

Presented by Ron Brown, Toxicologist at Risk Science Consortium and Piet Christiaens, PhD, Scientific Director at Nelson Labs
16th November 2022


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