Next-generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens or viral vectors produced using cell culture technologies. Regulatory guidelines require testing for cell substrate related impurities, media and purification additives, as well as adventitious agents throughout vaccine and gene therapy development to study the candidateâ€™s purity, safety, and efficacy. While low levels of most impurities can be inconsequential, patient safety demands that host cell proteins (HCPs) be eliminated or reduced to the lowest levels practical. A key step in downstream purification of viral vectors and recombinant vaccines is the selection of a platform HCP enzyme-linked immunosorbent assay (ELISA) kit or developing a custom HCP ELISA. One part of determining that the ELISA is fit for purpose is performing antibody coverage analysis.
In this webinar, we will discuss orthogonal Antibody Affinity Extraction and Mass Spectrometry methods used to assess ELISA Ab coverage to HCPs present in a process and identify process-specific HCPs that may copurify with a drug substance. Case studies of HEK 293, Sf9, and Vero cell-based processes will be presented.
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