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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

Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification

Overcoming Obstacles in AAV Viral Vector Manufacturing

Bringing the Freezing of Biopharmaceuticals in From the Cold

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

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Headline News

Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


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Upcoming Webinars

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Past Webinars

NIR In-Line Monitoring for Drug Product Continuous Process: From Understanding to Control

Presented by Yang (Angela) Liu
19th January 2016


Continuous Capture and Continuous Recovery – Novel Ideas for Product Recovery from Perfusion Process Using ATF

Presented by Dr. Kerstin Lange, Team Lead Process Technology and Innovation, Advanced Bioprocessing, Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech and Earl Pineda Sr. Manager, Upstream Field Applications EU/APAC at Repligen
03rd February 2021


DSF and FTIR as complementary methods for the identification and characterization of vaccine products

Presented by Marina Kirkitadze, Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur and Rina Dukor, President, BioTools
18th September 2018


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