Human hepatitis B immunoglobulins: Standardisation issues

INTRODUCTION. Human hepatitis B immunoglobulins (HBIGs) are produced from the plasma of vaccinated donors and are used to prevent hepatitis B virus infection. The main challenge associated with the quality control and efficacy evaluation of HBIGs is the lack of reference standards certified for the content of antibodies to hepatitis B virus surface antigen (HBsAg). Systematisation and analysis of the relevant experience in HBIG testing and manufacturing will contribute to the development of new approaches to HBIG standardisation.

AIM. This study aimed to characterise HBIGs and consider approaches to their standardisation.

DISCUSSION. Most HBIGs are developed in Germany (27%), Italy (17%), and the USA (17%) and are formulated for intramuscular (67%), intravenous (30%), and subcutaneous (3%) administration. The potency of HBIGs varies from 50 to 500 IU/mL. There are 3 HBIGs approved in Russia, but the available HBIGs do not fully cover the needs of prevention and treatment providers. The effectiveness of hepatitis B prevention directly depends on the HBIG dose, which is calculated using the potency of the HBIG. Ensuring the accuracy of HBIG potency determination requires a reference standard for anti-HBsAg antibodies certified in international units. The existing international standard for HBIGs has limited commercial availability in the Russian Federation, and the national (pharmacopoeial) reference standard for HBIGs is lacking.

CONCLUSIONS. The analysis of information on the currently manufactured HBIGs has identified recent development trends in this pharmaceutical industry sector. The future development and implementation of the national (pharmacopoeial) reference standard for anti-HBsAg antibodies will contribute to improving the quality of HBIGs and, therefore, the effectiveness of preventive immunisation against hepatitis B.

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