Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin
Introduction. Using of immunoglobulins containing SARS-CoV-2 neutralizing antibodies may be an effective and safe tool for COVID-19 treatment. An intravenous immunoglobulin COVID-globulin from donor blood plasma containing SARS-CoV-2 neutralizing antibodies was developed at Joint-Stock Company Nacim...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2023-02-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/1446 |
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| author | A. M. Nikolaeva A. V. Ivanov T. I. Smolyanova M. V. Razumikhin O. V. Belyakova E. G. Shilova N. R. Selezneva T. V. Vyaznikova A. I. Semicheva E. I. Sakanyan |
| author_facet | A. M. Nikolaeva A. V. Ivanov T. I. Smolyanova M. V. Razumikhin O. V. Belyakova E. G. Shilova N. R. Selezneva T. V. Vyaznikova A. I. Semicheva E. I. Sakanyan |
| author_sort | A. M. Nikolaeva |
| collection | DOAJ |
| description | Introduction. Using of immunoglobulins containing SARS-CoV-2 neutralizing antibodies may be an effective and safe tool for COVID-19 treatment. An intravenous immunoglobulin COVID-globulin from donor blood plasma containing SARS-CoV-2 neutralizing antibodies was developed at Joint-Stock Company Nacimbio.Aim. A pilot study of the safety of the "COVID-globulin".Materials and methods. When studying the safety of the preparation in animals the following parameters were evaluated: general toxicity, thrombogenic potential, influence on hematological and biochemical parameters, blood clotting and hemolytic activity, determination of local irritant action, pyrogenic properties, bacterial endotoxins, allergic effect of the drug preparation and its physicochemical characteristics.Results and discussion. Safety studies of "COVID-globulin" in animals showed no signs of intoxication, local irritant action and thrombogenic properties. Macroscopic and histological examination of the organs of rats treated with COVID-globulin showed no signs of necrosis, inflammation, atypia, or any significant pathological changes. Hematological and biochemical parameters of the blood of laboratory animals after the administration of "COVID-globulin" corresponded to the reference values. Administration of COVID-globulin to rabbits did not activate blood clot formation. The IgG subclasses distribution in the preparation corresponded to that in human plasma. The activity of the Fc-function of the immunoglobulin molecule was more than 130 % compared to the reference standard preparation, the concentration of the prekallikrein activator in the COVID-globulin ranged from 4.2 to 4.8 IU/ml, anticomplementary activity was less than 1 unit complement per 1 mg of protein.Conclusion. The results of all studies have demonstrated a high level of safety of the developed COVID-globulin preparation, which meets the safety requirements for human immunoglobulins for intravenous administration by national regulatory documents and the European Pharmacopoeia. |
| format | Article |
| id | doaj-art-4e46298347bc4800a66eece1ea63ebf5 |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2023-02-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-4e46298347bc4800a66eece1ea63ebf52025-08-20T03:59:04ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492023-02-0112115516010.33380/2305-2066-2023-12-1-155-1601083Preclinical Evaluation of a New Anti-COVID-19 Intravenous ImmunoglobulinA. M. Nikolaeva0A. V. Ivanov1T. I. Smolyanova2M. V. Razumikhin3O. V. Belyakova4E. G. Shilova5N. R. Selezneva6T. V. Vyaznikova7A. I. Semicheva8E. I. Sakanyan9JSC "NPO "Microgen"JSC "NPO "Microgen"JSC "Nacimbio"JSC "Nacimbio"JSC "NPO "Microgen"JSC "NPO "Microgen"JSC "NPO "Microgen"JSC "NPO "Microgen"JSC "NPO "Microgen"JSC "NPO "Microgen"Introduction. Using of immunoglobulins containing SARS-CoV-2 neutralizing antibodies may be an effective and safe tool for COVID-19 treatment. An intravenous immunoglobulin COVID-globulin from donor blood plasma containing SARS-CoV-2 neutralizing antibodies was developed at Joint-Stock Company Nacimbio.Aim. A pilot study of the safety of the "COVID-globulin".Materials and methods. When studying the safety of the preparation in animals the following parameters were evaluated: general toxicity, thrombogenic potential, influence on hematological and biochemical parameters, blood clotting and hemolytic activity, determination of local irritant action, pyrogenic properties, bacterial endotoxins, allergic effect of the drug preparation and its physicochemical characteristics.Results and discussion. Safety studies of "COVID-globulin" in animals showed no signs of intoxication, local irritant action and thrombogenic properties. Macroscopic and histological examination of the organs of rats treated with COVID-globulin showed no signs of necrosis, inflammation, atypia, or any significant pathological changes. Hematological and biochemical parameters of the blood of laboratory animals after the administration of "COVID-globulin" corresponded to the reference values. Administration of COVID-globulin to rabbits did not activate blood clot formation. The IgG subclasses distribution in the preparation corresponded to that in human plasma. The activity of the Fc-function of the immunoglobulin molecule was more than 130 % compared to the reference standard preparation, the concentration of the prekallikrein activator in the COVID-globulin ranged from 4.2 to 4.8 IU/ml, anticomplementary activity was less than 1 unit complement per 1 mg of protein.Conclusion. The results of all studies have demonstrated a high level of safety of the developed COVID-globulin preparation, which meets the safety requirements for human immunoglobulins for intravenous administration by national regulatory documents and the European Pharmacopoeia.https://www.pharmjournal.ru/jour/article/view/1446intravenous immunoglobulinpreclinical studiestoxicitysafetycoronavirus infectioncovid-19 |
| spellingShingle | A. M. Nikolaeva A. V. Ivanov T. I. Smolyanova M. V. Razumikhin O. V. Belyakova E. G. Shilova N. R. Selezneva T. V. Vyaznikova A. I. Semicheva E. I. Sakanyan Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin Разработка и регистрация лекарственных средств intravenous immunoglobulin preclinical studies toxicity safety coronavirus infection covid-19 |
| title | Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin |
| title_full | Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin |
| title_fullStr | Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin |
| title_full_unstemmed | Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin |
| title_short | Preclinical Evaluation of a New Anti-COVID-19 Intravenous Immunoglobulin |
| title_sort | preclinical evaluation of a new anti covid 19 intravenous immunoglobulin |
| topic | intravenous immunoglobulin preclinical studies toxicity safety coronavirus infection covid-19 |
| url | https://www.pharmjournal.ru/jour/article/view/1446 |
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