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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
Enabling Total Biopharma Solutions
Pall Life Sciences
Changing Column Packing from an Art into a Science
Current Status of Analytical Techniques for Characterization of Protein Stability
Dr. Sanket Patke, Research Investigator at Bristol-Myers Squibb with Dr. Joshua Stillahn and Dr Manning
Bringing the Freezing of Biopharmaceuticals in From the Cold
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AbbVie’s dual targeting ABBV-466 beats single drug treatment on endoscopic remission in Phase 2a Crohn’s disease study
Bristol Myers Squibb to present late-breaking iza-bren, pumitamig and Opdivo plus Yervoy data across solid tumours at ESMO 2026
CHMP backs TALVEY plus daratumumab for earlier-line relapsed or refractory multiple myeloma
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Upcoming Webinars
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New Tools to Assess the Risk of Microbial Impurities in the Pharmaceutical Manufacturing Process
Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche and Mathilde Arnault, Research Scientist, BioMonitoring R&D, Merck KGaA, Darmstadt, Germany
09th April 2019
Risk Assessment of Extractables and Leachables in Different Phases of Development.
Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Ward d’Autry, Study Director E/L & Structural Elucidation, Nelson Labs Europe
22nd April 2021
CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)
Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 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
Lifetime study for JSR Amsphere A3 – protein A resin
Caustic Stability of Amsphere A3 : Cycling Study with 0.5 M NaOH
Amsphere A3 – protein A resin: an optimized media to minimize the impact of elution buffer selection
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AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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