PG13 cell line is used for cost-effective production of a high-titer retrovirus capable of infecting human cells for gene and cell therapies. The manufacturing and purification process of these products leaves the potential for PG13-derived host cell protein (HCP) impurities. It is required to reduce HCP impurities to the lowest levels practical.
This simple to use, objective, and semi-quantitative ELISA is a sensitive and specific method to aid in optimal purification process development, process control, and in routine quality control and product release testing. This kit is “generic” in the sense that it is intended to react with essentially all of the HCPs that could contaminate the product independent of the purification process. The antibodies have been generated against and affinity purified using a mild lysate of PG13 cells. The antibodies used in this kit were characterized by Antibody Affinity Extraction (AAE) and Mass Spectrometry, demonstrating reactivity to the majority of HCPs.
Special procedures were utilized in the generation of these antibodies to ensure that low molecular weight and less immunogenic impurities as well as high molecular weight components would be represented. As such, this kit can be used as a process development tool to monitor the optimal removal of host cell impurities as well as in routine final product release.
This highly sensitive ELISA kit was qualified for testing of final product HCPs by using actual in-process and final drug substance samples. Each user of this kit is encouraged to perform a similar qualification study to demonstrate it meets their analytical needs. The suitability of this kit for a given sample type and product must be determined and qualified experimentally by each laboratory.