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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
Navigating Technology Transfer
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)
Pall Corporation
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
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FDA approves Teva’s DEGEVMA biosimilar to Xgeva across all reference product indications
Astellas begins Phase III trial of setidegrasib in KRAS G12D mutated advanced lung cancer
FDA approves Lilly’s Olumiant for adolescents with severe alopecia areata
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Upcoming Webinars
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Continuous Manufacturing of Biologics: A Journey from Concept to Reality
Presented by Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd. and Ganesh Kumar, MS, Market Entry Strategy Manager at Sartorius
15th September 2021
Mapping Future Technology Needs For Real Time Release Testing
Presented by Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb
09th August 2019
New Paradigm of Building Quality during Manufacture – Challenges with Biological Products
Presented by Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC
23rd August 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
Amsphere TM A3
Rationale Design of Valves for Flexible Processing
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
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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