April 30 @ 3:00 PM – 5:00 PM
Host cell proteins (HCPs) are process-related impurities deriving from host organisms used for the expression of biological products like recombinant proteins or viral vectors. HCPs, if not adequately controlled, can present potential risks to patient safety and compromise product quality, including stability, and have been the focus of regulatory agencies and industry for years.
The most common approach to test HCPs is to use an ELISA method that allows assessment of the level of HCPs at different stages of product manufacture, their clearance by manufacturing process, and content in the final drug product. However, the outcome of ELISA testing depends on test sensitivity and detection (coverage) of a variety of proteins constituting the HCPs for a given product. Furthermore, ELISA assays do not provide individual HCP identities and thus lead to an underestimation of the risk HCPs pose to product quality. Therefore, LC-MS/MS and other more suitable analytical methods have been incorporated to qualitatively assess HCPs including higher-risk impurities that may co-purify with the intended molecule and so-called “bad character ” that may affect quality and safety of the product especially during the long-term storage.
Panelists:
Andrew Chang, Novo Nordisk Inc.
Alexey Khrenov, CDER, FDA
Ling Wa, Arcellx, Inc.
Details
- Date:
- April 30
- Time:
-
3:00 PM – 5:00 PM
- Cost:
- Free
- Event Categories:
- Biohealth Capital Region, Biotech
- Event Tags:
- Arcellx, BioHealth Capital Region, CASSS, ELISA, FDA, HCPs, Host Cell Proteins, Novo Nordisk, Therapeutics
- Website:
- https://www.casss.org/discussion-groups/dc-discussion-group
Organizer
- CASSS
- Website
- View Organizer Website
Rockville, MD 20850 United States