PDA’s Biopharmaceuticals Week
May 6-10, 2019
Long Beach, California
Chen Li, Annie Wang, Wanlu Qu, Dongdong Wang, Jennifer S. Chadwick, Shiaw-Lin Wu
BioAnalytix Inc., Cambridge, MA.
Host cell proteins (HCPs) in recombinant protein products have been characterized increasingly by LC-MS based approaches as an orthogonal standard for typical ELISA detection. However, HCPs derived from human cell lines in typical gene therapy products are more complex than typical recombinant biologics produced in CHO or E. coli cell lines. Multiple viral proteins co-exist in gene therapy products, adding extra complexity compared to most biologic drugs expressed as single proteins in host cells. In this presentation, we will describe studies where we have developed advanced LC-MS approaches to determine the identity of HCPs while providing useful information about respective levels in gene therapy product samples. In addition, co-existing viral proteins were characterized simultaneously, determining the viral protein types as well as related cleavages. Overall, this LC-MS approach has the potential not only for monitoring key HCPs but also evaluating other viral product quality attributes concurrently, for example, to assess lot-to-lot comparability.