Aim of the study: Biopharmaceutical products may contain host cell derived protein impurities at low levels. A method for the detection of antibodies to HCP in human serum of patients treated with recombinant drug protein was validated for immunogenicity assessment.
Analyte: Anti-host cell antibodies.
Methodology: The ELISA method consists in a direct ELISA using antigen-coated microwell plates, while the detection system is a mixture of commercial HRP conjugated antibodies. Positive samples are confirmed by titration and specificity tests. The ELISA method was tested for sensitivity, specificity, intra- and inter-run accuracy and precision, and for inter-operator variability using spiked quality control samples.
System Human serum.
Therapeutic area: Reproductive Medicine.
Development stage: Preclinical.
Customer: Large pharmaceutical company.
Results: The ELISA method for detection in human serum of antibodies against host cell proteins of a recombinant protein produced in serum free medium was demonstrated to be accurate, precise, capable to confirm positive samples and sensitive and selective for the antigen.
Advantage of the methodology: Anti-host cell antibodies can activate immunogenic reactions in treated patients. Here, an accurate, precise and selective ELISA method was validated to detect the presence of these antibodies in patient serum.