November 05, 2020
Host Cell Proteins (HCPs) pose a common challenge to biopharmaceutical manufacturers as residual HCP can negatively influence the quality, safety and efficacy of drug products. The stepwise Downstream Processing (DSP) aims to purify the drug substance and requires the reliable monitoring of potential HCP impurities. This is usually carried out by an HCP ELISA as the method of choice, enabling an HCP measurement down to low ppm level. This method is based on antibodies that specifically detect HCP species in user-defined DSP samples which contain the drug substance. During ELISA development at BioGenes, a list of critical aspects is used to generate a powerful HCP assay. This includes the correct choice of a suitable mock antigen, a sophisticated immunization strategy, comprehensive reagent characterization and a targeted ELISA set-up.
Join featured speakers from BioGenes, Stefan Sommerschuh, Head of Assay Development; Pia Paarmann, PhD, Head of 2D Analytics; and Martin Föge, PhD, Business Development Manager, in a live webinar on Thursday, November 19, 2020 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Challenges and Solutions in Host Cell Protein ELISA Development.
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