On-demand webinar: Extractables profiles for chromatography resins
Posted: 22 October 2020 | Merck | No comments yet
Extractables studies for chromatography resins based on the adapted requirements of the USP <665> support risk evaluation for chromatography steps.
To conduct comprehensive risk assessment in biopharmaceutical manufacturing, detailed information on any component or material in contact with the drug substance/ product is required. There are no explicit guidelines on testing procedures for chromatography steps yet. In the upcoming USP <665> chapter, chromatography steps are in focus as well as any plastic or polymeric component. The webinar demonstrates an adapted extractables study approach developed to support chromatography resin users.
Related topics
Biopharmaceuticals, Bioprocessing, Chromatography, Good Manufacturing Practice (GMP), Manufacturing, Regulation & Legislation, Supply Chain
