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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
Navigating Technology Transfer
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
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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FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines
Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis
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Upcoming Webinars
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Challenges Faced by the End Users During the Qualification of Single Use System
Presented by Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager / Business Development Manager R&D at SGS Group
14th January 2019
Rapid Microbiology Applications in the COVID-19 Era
Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020
Changing the Paradigm: Moving to In-Process Release Testing
Presented by Presented by Scott Weiss, Director, Industrial Microbiology at Johnson & Johnson and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
05th February 2021
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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.
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Technical Papers
Amsphere TM A3
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
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Decrease Cleaning Validation Time and Resources
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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