Manufacturing and Bioprocessing
2019 PharmSci 360
Monitoring of residual host cell proteins (HCPs) impurities is a major critical quality attribute (CQA) in process development of biologics and cell & gene therapies. Residual impurities have the potential to impact product quality, safety, stability and efficacy, and thus highly sensitive, high throughput assays to monitor HCP impurities specific to the manufacturing host cell line are essential. Join us for the presentation of several case studies for the development of HCP impurity detection and viral titer assays based on Gyrolab® nanoliter-scale immunoassay technology, including CHO-, HEK- and E coli- specific HCP assays and p24 viral titer assays, as well as their implementation to overcome the challenges faced by standard ELISAs.