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...
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Featured Articles
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
Enabling Total Biopharma Solutions
Pall Life Sciences
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
Overcoming Obstacles in AAV Viral Vector Manufacturing
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Novo Nordisk and Anthropic to team up on accelerating drug discovery through Claude
Körber certifies ZETA’s INOSIM Foresight for PAS X MES data integration
FDA approves Lilly’s once weekly Onswik insulin for adults with type 2 diabetes
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Upcoming Webinars
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Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?
Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe
03rd February 2020
Application of USP 665 data to support qualification of single use systems
Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020
Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
Presented by Presenter: James Hathcock, Ph.D., Moderator: Hélène Pora, Ph.D.
29th June 2017
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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
Rationale Design of Valves for Flexible Processing
Best Practices for Achieving Virus Safety
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
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Decrease Cleaning Validation Time and Resources
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Amsphere™ A3 Protein A Resin – JSR Life Sciences
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