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
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma
Continuous processing optimization with smarter tools
Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific
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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Enhertu approved in EU for HER2-positive early breast cancer with residual disease
ELREXFIO improves progression-free survival in Phase III relapsed multiple myeloma trial
Johnson & Johnson to present 26 Impella studies at TCT 2026
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Upcoming Webinars
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Affinity Chromatography for Vaccines Purification
Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
12th May 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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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
Strategy Emerging Markets for Risk Mitigation
Amsphere TM A3
Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120 Auto Culture Mode
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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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