Blood preparations of humans and animals in terms of their quality, efficacy and safety

• Published in: Biopreparaty no. 3; pp. 33 - 48
• Main Authors: M. V. Supotnitsky, A. A. Elapov, I. V. Borisevich, E. Yu. Kudasheva, V. I. Klimov, E. V. Lebedinskaya, L. V. Korsun, E. V. Gorbunova, V. G. Slobodayn, V. A. Merkulov, Yu. V. Olefir
• Format: Magazine Article
• Language: Russian
• Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products 01.02.2018
• Subjects: cryoprecipitate; fc-fragment; fc-фрагмент; hbsag; hepatitis a, b and c; hiv-1; hiv-2; igg; immunoglobulins for intramuscular administration; intravenous immunoglobulin; isoagglutinins to antigens a, b, d; measles; monomeric igg; parvovirus b19; polyclonal antibody; prion; sepsis; who; вирусы гепатитов а, в и с; вич 1; вич 2; воз; изоагглютинины к антигенам а, в, d; иммуноглобулины для внутривенного введения; иммуноглобулины для внутримышечного применения; корь; криопреципитат; мономерные igg; парвовирус в19; поликлональное антитело; прион; сепсис
• ISSN: 2221-996X; 2619-1156

The problems of quality and safety products derived from human blood plasma and hyperimmune animal sera as well as recombinant blood products resolved strict government regulation of their production processes. The risk of implications is minimized by plasma fractionation and purification of a specific drugs from various impurities (immunoglobulin aggregates, protease, plasmin, plasminogen, prekallikrein activator, IgA and IgM etc.). Viral safety is achieved by multi-step manufacturing process that includes at least two independent methods (treatment with solvent/detergent + incubation at low pH or pasteurization, combined with polyethylene glycol processing). It was justified that for today the technological process of the development of plasma preparations and hyperimmune animal sera has reached its limit. Their further development is the most likely to refer to specific improvements. The improvements will relate to increasing the efficiency of manufacturing technologies and methods of clinical use (preparations for subcutaneous administration, combinations of different immunoglobulin preparations, etc.), viral safety, ways to eliminate component, that were previously not considered to be able to influence the outcome of clinical use (soluble molecules CD4, CD8, HLA, thrombin, trace amounts of blood clotting factors VIII, IX, X, XI, XII etc.). At the same time new genetic engineered preparations with well-characterized molecular composition and a high selectivity for target impact are expected to appear on the market because of these unsolved issues. These are recombinant blood factors with altered properties; cocktails of recombinant antibodies and Fab-fragments of IgG, highly affine for toxin epitopes, etc. Therefore, in the upcoming years it is necessary to create in Russia a new system for assessing the quality, efficacy and safety of blood products, taking into account the future course of their development.