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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

Process Analytical Technology For Upstream Bioprocessing

Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER

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

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

Current Status of Analytical Techniques for Characterization of Protein Stability

Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning

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Headline News

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

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

Regeneron CIDEBsiRNA delivers up to 80% liver fat reduction in early MASLD study

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Upcoming Webinars

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Past Webinars

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

Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production

Presented by Ping Wang, Director at Johnson & Johnson and Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services
23rd March 2020

How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
19th September 2019

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Featured Video

At Pall we help you select the process model that’s perfect for you. Ensuring it’s adapted to meet your precise needs and assembled flawlessly, ready for the future, from day one.

There’s no kit for the perfect biotech process. Until now.

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