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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

Coupling single-pass TFF before loading onto a chromatography sorbent

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

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

James Barry, Director of Marketing, Americas, Pall Biotech

Bringing the Freezing of Biopharmaceuticals in From the Cold

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Headline News

Gilead to present 28 abstracts on HIV treatment, prevention and emerging antiviral research at IDWeek 2026


Sanofi begins construction of new insulin manufacturing facility in Frankfurt


Gilead extends lenacapavir licensing deals to cover investigational once yearly HIV prevention shot


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Upcoming Webinars

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Past Webinars

CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy

Presented by Sarah Thomas, Vice President of Quality at REGENXBIO Inc. and Joanna Zmurko, NGS specialist at PathoQuest
23rd March 2022


Enabling comprehensive data analytics and process monitoring in Biomanufacturing – Key success factors, methodologies and practical insights that lead to a successful implementation

Presented by Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D
17th January 2018


Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories and Veronika Wills, Manager, Technical Services At Associates of Cape Cod, Inc
09th September 2021


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