Method for creating reserve of blood plasma for production of standard samples of human tetanus immunoglobulin

Abstract

FIELD: medicine; production transfusiology.SUBSTANCE: method is used to create a reserve of blood plasma for the production of standard samples of human tetanus immunoglobulin. Preliminary, taking into account information on the presence of vaccination against tetanus in blood and blood component donors in accordance with the national calendar of preventive vaccinations, forming a contingent of individuals. Then, in individuals vaccinated against tetanus no more than 5 years ago, assessing the strength of immunity. Wherein, determining the content of IgG antibodies to tetanus toxin by enzyme immunoassay. Then, for the production of standard samples of human tetanus immunoglobulin, selecting blood plasma with a concentration of specific antibodies in the blood serum of at least 3 IU / ml.EFFECT: donor reserve for harvesting blood plasma containing antibodies to the tetanus pathogen.1 cl

Description

[0001] The invention relates to the field of industrial transfusiology, namely to a method for creating a donor reserve for the preparation of blood plasma containing antibodies to the tetanus pathogen.

[0002] Specific immunoglobulins, including human tetanus immunoglobulin, are in demand for the prevention and treatment of many infectious diseases. It is obtained from immunospecific blood plasma enriched with antibodies to the tetanus pathogen. This substance is also necessary for obtaining a standard sample of human tetanus immunoglobulin, against which the primary quality indicator of this medicinal product—specific activity—is assessed. Such blood plasma can be collected from immunized individuals. The availability of donor reserves determines the efficiency and completeness of raw material supply for pharmaceutical production in this specialty.

[0003] Currently, the Russian Ministry of Health's Order No. 750n dated November 21, 2022, regulates the procedure for immunizing donors for the collection of immune-specific blood plasma, including plasma containing antibodies to the tetanus pathogen. In this case, individuals with a serum specific antibody concentration of at least 7 IU / ml are permitted to donate [https: / / www.consultant.ru / document / cons_doc_LAW_146049 / ]. The approved method has several drawbacks:

[0004] includes the stages of forming a special group of donors and carrying out their vaccination,

[0005] does not define the requirements for the content of antibodies to the causative agent of tetanus in immunospecific blood plasma for the production of a standard sample of human tetanus immunoglobulin.

[0006] The objective of the invention is to improve the method for obtaining raw materials for the production of medicinal products and a standard sample of human antitetanus immunoglobulin.

[0007] The technical result is to increase the availability of a substance for the production of medicinal products and a standard sample of human anti-tetanus immunoglobulin due to the possibility of preparing blood plasma containing antibodies to the tetanus pathogen without additional recruitment and preliminary immunization of donors.

[0008] The technical result is achieved by forming a contingent of persons immunized against tetanus by collecting and analyzing information on the presence of tetanus vaccination in donors of blood and its components in accordance with the national calendar of preventive vaccinations, taking into account the timing of its implementation, assessing the intensity of immunity to the tetanus pathogen by taking blood samples from a vein in a volume of at least 3 ml in a vacuum tube with a coagulation activator, isolating blood serum by centrifugation at room temperature for 10 minutes at a rotation speed of 3000 rpm and determining the content of IgG antibodies to tetanus toxin by enzyme immunoassay, selecting potential donors of blood plasma containing antibodies to the tetanus pathogen, and systematizing information about potential donors.

[0009] At the stage of assessing immunity to the tetanus pathogen, individuals vaccinated in accordance with the national immunization schedule, but no more than five years ago, are screened. This allows for the identification of potential donors of immune-specific blood plasma among immunized individuals already involved in this type of donation. Continuous screening of vaccinated individuals allows for the continued expansion of the donor pool.

[0010] Requirements for the specific antibody content of raw materials for the production of a standard sample of human tetanus immunoglobulin have also been established: at least 3 IU / ml, expanding the potential use of blood plasma containing antibodies to the tetanus pathogen. The availability of immune raw materials will facilitate the expansion of the production of human tetanus immunoglobulin medicinal products and their standardization.

[0011] The claimed invention is explained by an example.

[0012] To implement the method, information is collected and analyzed on the tetanus vaccination status of blood and blood component donors in accordance with the national immunization schedule, taking into account the timing of vaccination. For example, of the 507 respondents, 385 reported the date of vaccination. Of these, 176 were vaccinated no more than five years ago.

[0013] To assess the level of immunity to tetanus in 176 donors vaccinated no more than five years ago, blood samples of at least 3 ml are collected from a vein in a vacuum tube containing Acti-Fine clot activator. Serum is isolated from the collected blood samples by centrifugation at room temperature for 10 minutes at 3000 rpm. Aliquots of at least 250 µl are prepared from the resulting serum samples and, if necessary, stored at -20°C for no more than 1 month.

[0014] Prepared serum samples are thawed at room temperature if necessary and their IgG antibody content to tetanus toxoid is determined by enzyme-linked immunosorbent assay using the Anti-Tetanus Toxoid ELISA (IgG) reagent kit. For example, in 122 samples, the indicated value does not exceed 3 IU / ml, in 50 samples it ranges from 3 IU / ml to 7 IU / ml, and in 4 samples it is above 7 IU / ml.

[0015] Potential donors of immune-specific blood plasma are being selected for the production of human anti-tetanus immunoglobulin (with a serum specific antibody concentration of at least 7 IU / ml). In this example, four individuals with the required immune strength were identified.

[0016] Potential donors of immune-specific blood plasma are selected for the production of a standard sample of human antitetanus immunoglobulin (with a serum specific antibody concentration of at least 3 IU / ml). In this example, 54 individuals were selected.

[0017] Systematize information on potential donors of blood plasma containing antibodies to the tetanus pathogen. In this example, according to the information obtained, immunospecific blood plasma for the production of human tetanus immunoglobulin medications can be prepared from 4 donors (2% of those tested), and for the corresponding standard sample, from 54 donors (31% of those tested).

[0018] To expand the pool of potential donors of blood plasma containing antibodies to the tetanus pathogen, it is advisable to continue screening vaccinated individuals. For example, to form a pool of 100 potential donors of immune-specific blood plasma for the production of human tetanus immunoglobulin, it is necessary to assess the immunity of approximately 5,000 donors of blood and blood components vaccinated no more than five years ago.

[0019] The presented example does not limit the scope of the present invention and serves only to illustrate and disclose the claimed method.

[0020] Industrial applicability

[0021] The technical task, namely, improving the method for obtaining raw materials for the production of medicinal products and a standard sample of human anti-tetanus immunoglobulin, has been achieved, which is confirmed by an example of using the proposed method.

[0022] The practical application of the claimed invention will make it possible to create a donor reserve for the procurement of blood plasma containing antibodies to the tetanus pathogen, without additional involvement of donors and their immunization.

[0023] The use of the proposed method will contribute to increasing the effectiveness of tetanus therapy due to the availability of raw materials for the production of human anti-tetanus immunoglobulin, increasing the production volumes of these drugs and their standardization.

Claims

1. A method for creating a donor reserve for the procurement of blood plasma containing antibodies to the causative agent of tetanus, which consists of forming a contingent of persons immunized against tetanus by collecting and analyzing information on the presence of tetanus vaccination in donors of blood and its components in accordance with the national calendar of preventive vaccinations, taking into account the timing of its implementation, assessing the intensity of immunity to the causative agent of tetanus by taking blood samples from a vein in a volume of at least 3 ml in a vacuum tube with a coagulation activator, isolating blood serum by centrifugation at room temperature for 10 minutes at a rotation speed of 3000 rpm and determining the content of IgG antibodies to tetanus toxin by enzyme immunoassay, selecting potential donors of blood plasma containing antibodies to the causative agent of tetanus, and systematizing information on potential donors.

2. The method according to paragraph 1, characterized in that at the stage of assessing the intensity of immunity to the tetanus pathogen, persons vaccinated in accordance with the national calendar of preventive vaccinations, but not more than 5 years ago, are examined.

3. The method according to paragraph 1, characterized in that potential donors of blood plasma are identified and registered for the production of medicinal products of human antitetanus immunoglobulin with a concentration of specific antibodies in the blood serum of at least 7 IU / ml and a corresponding standard sample with a concentration of specific antibodies in the blood serum of at least 3 IU / ml.