Introduction of Viral Vector Purity Evaluation Service

Viral vectors expressing therapeutic genes show great promise for the treatment of a wide range of diseases, particularly rare diseases, and represent an emerging new therapeutic paradigm. One of the challenges in making progress in the development of current viral vector-based investigational products is the identification and characterization of the product- and process-related impurities present in even highly purified formulations.

During the production of viral vectors for gene delivery, impurities are often derived from the host cell system where the vector product is produced or from downstream purification processes. It is necessary to develop sensitive methods to measure host cell protein (HCP), host cell DNA (HC DNA), and common pollutants, which is crucial to identify the impurities in the vector prepared for the development of human rare disease treatment products, and helps to ensure and control the purity, efficacy, and safety of products.

Fig. 1 Adeno-associated virus (AAV) vector and impurity levels during purification. (Wright J F, 2014)