The quality of materials and reagents used in Cell and Gene Therapy (CGT) production processes plays avital role in determining both the product quality as well as therapeutic safety, and external contaminantsmust be strictly controlled.
Host Cell Proteins (HCPs) are impurities that are acquired during biotherapeutic production, Sino Biological has a huge range of methods and reagents to aid in detection and quantification.
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2D gel analytics and LC-MS are the most common methods for HCP reagent characterization, and should ideally both be used to maximize information about HCP antibody suitability for impurity detectionBioGenes and Alphalyse have shown how their different methodological approaches to reagent characterization.