A challenge for the current pipeline of AAV-based investigational products as they advance through clinical development is the identification, characterization and lot-to-lot control of the process- and product-related impurities present in even highly purified preparations. One important process related impurity is the host cell protein. Because the low yield of AAV vector product, the vector is normally purified from an excessive amount (~several hundred fold by mass) of host cell protein. The final amount of host protein must be controlled and monitored.

At Novabioassays we provide ELISA methods to quantify host cell proteins and we also provide nanoLC-MS/MS solutions for proteomic analysis of the host protein for in-process and purified vector production samples.