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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
Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)
Pall Corporation
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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mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults
Regeneron CIDEBsiRNA delivers up to 80% liver fat reduction in early MASLD study
Onchilles reports early systemic activity with intratumoral N17350 in Phase I/II trial
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Upcoming Webinars
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Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
Presented by Aaron Mack, Engineer at Biogen and Dave Kolwyck, Director Materials Science at Biogen and David Gemmell Senior Process Engineer at Merck
17th October 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 Companies
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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
Lifetime study for JSR Amsphere A3 – protein A resin
Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120 Auto Culture Mode
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
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Featured Products
Decrease Cleaning Validation Time and Resources
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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