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
Benefits of Mixed-Mode Cation Exchange Chromatography: CMM HyperCel™ Sorbent Used for Monoclonal Antibody and Other Recombinant Protein Purification
Choice of Upstream Bioreactor Technologies for Industrial Scale Viral Manufacturing (White Paper USD3244)
Pall Corporation
Process Analytical Technology For Upstream Bioprocessing
Erica Fratz-Berilla and Cyrus Agarabi, FDA CDER
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Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences
Livdelzi improves ALP normalisation rates in Phase III PBC study
Zura Bio discontinues tibulizumab development in hidradenitis suppurativa after Phase II miss
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Upcoming Webinars
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Utilizing Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development and manufacturing scale up
Presented by Sanjeev Gupta, Ph.D., Vice President and Head Advanced Biotech (Biosimilar Division), Ipca Laboratories Ltd., Mumbai-India
15th November 2022
Current Progress in Approaches for The Safety Assessment of Extractables and Leachables
Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services
06th April 2018
An impurity detected in a stability study: Did we miss anything in our E&L risk assessment?
Presented by Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe
15th March 2022
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Featured Companies
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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
From Compliance to Circularity: Three Ways Pharma Manufacturers Can Rethink Resource Management
Column Packing Protocol for Amsphere A3
Lifetime study for JSR Amsphere A3 – protein A resin
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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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