Development, screening and quality specifications of hybridomas synthesizing anti-polypeptide hormone antibodies to be used for diagnostic tests and in-process control.

Hybridomas were developed for the production of monoclonal antibodies against human chorionic gonadotrophin (hCG) and against bovine and porcine (pro)insulins. Screening tests were devised to select those hybridomas synthesizing antibodies with predefined antigen-specificity. Cell lines, which produce anti-hCG antibodies with a low cross-reactivity against luteinizing hormone (hLH) and which are suitable for agglutination tests, were isolated. In addition hybridomas were obtained with various specifications for porcine and bovine (pro)insulins. Their monoclonal antibodies can be used for quantitative enzyme immunoassays of insulin and proinsulin mixtures. Specifications of hybridomas for production purposes have been defined with regard to growth requirements, antibody production capacity and absence of mycoplasma contamination.