Immunogenicity of biotechnological preparations

Study of immunogenicity parameters of biotechnological medicinal products in preclinical studies.

The study is conducted by identifying and confirming the presence of binding antibodies to the medication in samples using enzyme immunoassay methods, as well as identifying samples with antibodies that have neutralizing activity using enzyme immunoassay methods or cellular techniques validated in accordance with the current regulatory requirements of the EAEU.

To implement immunogenicity studies, it is possible to develop our own test systems or use commercially available reagent kits.

As part of pharmacokinetic studies, biosamples are stored at a temperature not exceeding -65 °C for two months after completion of the study, followed by disposal.