Host Cell Proteins (HCP) and process related contaminants are biological impurities that may remain in recombinant drug products even after extensive purification. Such impurities pose potential safety risks to patients resulting from their known immunogenicity effects. Thus, the proper identification and quantitation of these impurities is critical in producing a safe therapeutic. At BioReliance, our Immunoassay and Cell Based Services team is experienced in performing routine HCP assays as well as developing and validating custom HCP assays. We offer a full spectrum of HCP and bioprocess contaminant ELISA assays including:
Bioprocess Contaminant testing:
BioReliance has the committed scientists, regulatory expertise, and industry experience to support you fully throughout the testing process. Contact us for more information.
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