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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...
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Featured Articles
Productivity and Economic Advantages of Coupling Single-Pass Tangential Flow Filtration to Multi-Column Chromatography for Continuous Processing
Mark Schofield, Ph.D., Karl Rogler, Xhorxhi Gjoka, Engin Ayturk, Ph.D., and René Gantier, Ph.D.
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Characterization and Engineering Performance of the Allegro™ STR 500 Single-Use Stirred Tank Bioreactor
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
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FDA places Bright Minds’ planned BMB-101 Phase II epilepsy study on partial clinical hold
Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial
FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy
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Upcoming Webinars
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Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza
02nd February 2023
Shortages of critical raw materials and managing changes and substitutions
Presented by Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly and Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions on Behalf of Nelson Labs
28th April 2022
We Are Going Back to the Future with Rapid Methods.
Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Félix Montero-Julian, Scientific Director at bioMérieux
14th February 2022
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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
Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120 Auto Culture Mode
Amsphere TM A3
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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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