Current Issue
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
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
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
Endotoxin Control Strategies for Parenteral Drug Product Manufacturing
Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA
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FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI
FDA approves Abbott’s Amplatzer Paraclose device for heart valve leaks
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Upcoming Webinars
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Development of automated chemometric platform for accelerated Raman-based model optimization in biologics
Presented by Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen and Followed by Brian Rohrback, President and CEO of Infometrix, Inc.
20th September 2021
Do Extractable Protocols Truly Help – An End User Perspective
Presented by Ekta Mahajan, Genentech/Roche and Dr. Saskia Haehn, Laboratory Manager for Extractables & Leachables at Central Analytics of Merck KGaA, Darmstadt Germany
08th May 2019
Applying Low Frequency Raman to QbD in Pharmaceutical Development
Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb Company and James Carriere, Product Line Manager for Coherent’s THz-Raman product line
26th April 2019
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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
Best Practices for Achieving Virus Safety
Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120 Auto Culture Mode
Amsphere TM A3
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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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