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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

Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems

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

Overcoming Obstacles in AAV Viral Vector Manufacturing

Changing Column Packing from an Art into a Science

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Headline News

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


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


Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial


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Upcoming Webinars

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Past Webinars

Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing – A Reality Check

Presented by Joachim Walter
08th February 2018


Extractables from Single-Use Bioreactors/Bags and Impact on Cell Culture Performance

Presented by Yasser Nashed-Samuel, Principal Scientist at Amgen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
22nd January 2019


Development and Manufacturing of Recombinant Nanoparticle Vaccines

Presented by Atin Tomar, President & CEO, CPL Biologicals Pvt. & Amélie Boulais, Vaccine Platform Marketing Manager, Sartorius Stedim Biotech
12th July 2018


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