Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing
Posted on February 11, 2015
By: Weibing Ding, Principal Scientist in Process Development
Amgen Inc
Gary Madsen, Senior Principal Scientist
Pfizer Analytical R&D BioTherapeutics Pharmaceutical Sciences
Ekta Mahajan, Senior Engineer in Pharmaceutical Technical Development Engineering group
Genentech/Roche
Seamus O’Connor, Associate Manager, Analytical Sciences, Industrial Operations and Product Supply
Regeneron Pharmaceuticals, Inc
Ken Wong, Deputy Director in Process Technology group
Sanofi Pasteur
This article presents a concensus standardized extractables testing protocol for single-use systems in biomanufacturing. The Need General requirements for Extractables and Leachables (E&L) are already mandated by regulatory agencies.1-2 Biopharmaceutical companies must meet these requirements in...
To read the full article and other articles in this issue, please register for a free account or log in.
We will not sell or give your information to a third party. See our Privacy Policy
Related Topics and Keywords
analysis of leachable and extractable, biomanufacturing, e&l assessment, Extractable, extractables & leachables, gc-ms, hplc-uv-ms, icp-ms, icp-oes, Leachables, risk-based data, single-use, Single-use technologies
Related Product Videos
ReadyToProcess WAVE™ 25 - GE Healthcare Life Sciences
Flexsafe - Sartorius Stedim Biotech
Related Products
Independent control of parallel cell cultures - GE Healthcare Life SciencesBioreactor BIOSTAT® D-DCU - Sartorius Stedim Biotech
SmartRocker™ - Finesse
Subscribe to our FREE newsletter and WEBINAR UPDATES
We will not sell or give your information to a third party. See our Privacy Policy
