Obtaining of the Stable Formulation of Reference Sample for Human IgG Antibodies to Tick-Borne Encephalitis

Abstract

To ensure a long-term stability of the reference IgG antibodies to tick-borne encephalitis is an urgent task. The shelf life of immunoglobulin isolated from human immune blood plasma can be increased by freeze-drying an antibody solution stabilized with L-proline and glycine at a concentration of 12.5 g/L each and adjusting the pH value to 5.0± 0.5. The proposed method was used to obtain 3 batches of a reference sample with a shelf life from 30 to 48 months. During this time, the tested samples retained constant potency, fragmentation, absobance (400 nm) and dissolution time, which allows predicting its further stability during storage. The proposed method can also be helpful for obtaining stable antibody lyophilisates for use as standards in the analysis of the specific activity of human immunoglobulins against tick-borne encephalitis. reference standard, human tick-borne encephalitis immunoglobulin, L-proline, glycine, lyophilization, specific activity, production technology The work was carried out in accordance with the state assignment "Improvement of Quality Control Methods for Human Immunoglobulins".