Host cell proteins (HCPs) produced or encoded by the organisms are unique to their respective hosts (types and strains) used for biologics production. Due to their potential impact on product quality and efficacy as well as patient safety, the total amount of residual HCP in a biological drug substance generally is considered a critical quality attribute (CQA) that usually needs to be tested for during batch release. Commonly HCP presents in small quantities (parts per million expressed as nano grams per milligrams of the intended recombinant protein). The sandwich immunoassay, designed with polyclonal antibodies, is the workhorse of HCP monitoring and quantitation. This assay format offers a combination of high sensitivity, specificity, throughput, automation potential, rapid turnaround, quantitative results, and low cost per assay that is unmatched by any other currently available assay technology. HCP quantitation kits produced by ExCellBio are type of generic assays using the combination of upstream isolates and corresponding polyclonal antibodies as the major ELISA assay components.
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