Antibody Affinity Extraction™ And Mass Spectrometry Services

Empower your host cell protein identification with advanced orthogonal methods

Host cell proteins (HCPs) constitute a major group of impurities for biological drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability. A broadly-reactive HCP ELISA should be used during purification to ensure HCP removal and to demonstrate process consistency and final DS purity. Even a well-qualified generic or process-specific ELISA, however, does not provide information about the identities of the HCPs present in a DS.

Building on more than 20 years’ experience in HCP analysis, Cygnus advanced orthogonal Antibody Affinity Extraction™ (AAE™) and AAE-MS services are designed to detect and identify HCP impurities to help optimize your downstream purification processes and identify any potential HCP impurities in your DS. In addition, AAE-MS represents a more objective and direct method to qualify the ELISA as fit for purpose of detecting those HCP that co-purify with your drug substance.