DEVELOPMENT AND VALIDATION OF IMMUNOASSAY FOR IMMUNOGENICITY OF INTERFERON-ALPHA 2A DRUGS

Abstract

Interferons were one of the first groups of cytokines to be cloned and produced in bacteria. Interferon-based drugs are widely used for treatment of various infections, inflammatory and autoimmune diseases and malignant tumors. Clinical use of interferons can result in wide range of side effects, including unwanted influence on immune system of patients. Therefore it is important to study immunogenicity of interferones. The method of indirect ELISA was adopted and validated for analysis of antibodies to human recombinant interferon in mice blood plasma. The specificity was confirmed for mice antibodies. The linearity was 3.75-60.00 ng/ml, the detection limit was 2.19 ng/ml. Accuracy, interday and intraday precision did not exceed 15% at all concentration levels, that satisfies all validation requirements.

Keywords

• immunoglobulins
• antibody
• alpha-interferon
• blood plasma
• elisa
• validation