Russia (bbabo.net), - The developers of the Sputnik V vaccine have announced that they are working on an anti-COVID drug based on artificially synthesized monoclonal antibodies. At the same time, a medicine based on antibodies from the plasma of recovered patients has been registered and is already being used - it was called "COVID-globulin".

What are the possibilities in the use of such drugs? Why did work on the drug continue, although at some point the WHO announced the futility of such drugs? Tatyana Smolyanova, one of the authors of the drug development and production project, an expert of the Nacimbio holding of the Rostec State Corporation, told about this.

Why did you decide to develop a traditional immunoglobulin obtained from the plasma of recovered donors, and not to synthesize monoclonal antibodies, as foreign developers do?

Tatiana Smolyanova: With the beginning of the active spread of the infection, manufacturers have thrown all their resources and competencies into the fight against coronavirus. Companies that specialized in monoclonal antibodies began developing anti-COVID drugs on existing platforms.

Global manufacturers of blood products, in turn, began to develop specific immunoglobulins against COVID-19. Such work has been going on in Israel and Italy since April 2020. Several of the world's largest manufacturers have created an international alliance for the same purpose.

It is logical that Rostec, which includes a key manufacturer of blood products in Russia, including specific immunoglobulins, also set the task of developing its own immunoglobulin. Even before the pandemic, Nacimbio had a technological platform ready, we devoted a lot of time to developing criteria for selecting raw materials.

The plasma drug will "automatically" "adjust" to the changing virus

We also made a full scope of preclinical studies and started clinical studies. When the coronavirus epidemic began, the task was to create an immunoglobulin specifically against this infection.

How does the drug work?

Tatiana Smolyanova: The use of highly purified immunoglobulin is based on the principle of passive immunization. The active principle of the drug is immunoglobulins (antibodies) of class G isolated from the plasma of donors, which have specific activity against the SARS-CoV-2 virus.

The antibodies bind to a protein on the surface of the virus, preventing it from entering cells and blocking its spread in the body. The introduction of the drug, thus, helps the body prevent the transition of the disease into a more severe form and overcome the infection.

But the raw material - donor plasma - is heterogeneous: someone has a higher level of antibodies, someone has a lower one. How does this affect efficiency?

Tatiana Smolyanova: Efficiency depends on how the process of selecting raw materials - blood plasma - is organized. All the biomaterial that we use undergoes a strict selection for the level of virus neutralizing activity - this is our unique technology. Based on this criterion, only part of the plasma containing high titers of immunoglobulin G reaches production. This allows the drug to be produced with a certain standardized concentration of virus-neutralizing antibodies in each vial.

It turns out that some of the raw materials have to be rejected? How is the issue of raw materials being solved in general - this is not a chemical synthesis, but donated blood? In Moscow, for example, they offer those who have recovered from COVID-19 to become plasma donors for a tangible fee.

Tatiana Smolyanova: Yes, only plasma with a high titer of virus-neutralizing antibodies is used for production. We have quite a few partners in plasma preparation. The Moscow government supported the project at the start and provided us with raw materials for clinical trials. Now, after the successful completion of the tests, we continue to cooperate with the Moscow Department of Health and with blood transfusion stations in the regions of Russia.

Where is the drug produced and what will happen to production when the epidemic ends and there are simply no donors with a high antibody titer?

Tatiana Smolyanova: A new production site has been launched at the Microgen site in Perm for the serial production of COVID-globulin. When the epidemic is over, it will switch to the production of other highly purified blood products.

The use of donor blood or plasma implies risks that the raw materials may be contaminated with other viruses. How is this problem solved?

Tatiana Smolyanova: One of the most important stages in production is cleaning. The production technology of "COVID-globulin" complies with modern international standards of purity and virus safety. It includes chromatographic purification and four steps of virus inactivation and removal. This allows the production of a highly purified virus-safe drug.Nevertheless, WHO recently stated that it does not recommend transfusion of plasma with antibodies as a treatment for COVID-19, because this method is not effective. Why does "COVID-globulin" work?

Tatiana Smolyanova: In order for a specific immunoglobulin preparation to be effective, it must contain a sufficient amount of working antibodies. Usually this indicator is the titer in the live virus suppression reaction. Also with the use of covid plasma and the drug "COVID-globulin" - we need to be sure that in each dose we have a sufficient amount of active antibodies. Therefore, the key point in ensuring efficiency is the selection of raw materials, which I have already mentioned.

There is another important point: our drug will "automatically" "adjust" to the changing virus - due to the fact that it is based on the plasma of those who have recovered, the specificity of the antibodies in the drug will change depending on which version of the virus is relevant. Therefore, our drug will remain effective regardless of changes in the variants of the virus.

The fact that the drug works is confirmed by clinical studies. In 70% of cases, its use prevented the development of a cytokine storm, acute respiratory distress syndrome and other complications in covid patients.

The drug is also promising for patients with primary immunodeficiencies and blood diseases. There are patients in whom the immune system after infection cannot cope with the production of the necessary antibodies on its own. We presented the successful experience of using "COVID-globulin" in such patients at a recent conference "Current issues in the diagnosis and treatment of COVID-19 in patients with diseases of the blood system."

Publications are also being prepared in authoritative Russian and foreign medical journals.

When the epidemic ends, production will be switched to the production of other highly purified blood products

Is the drug being treated already? Where is it used?

Tatiana Smolyanova: Therapy with specific immunoglobulin is included in the current temporary guidelines for the treatment of COVID-19 of the Ministry of Health of Russia and is carried out only in a hospital setting. Regions in different volumes buy the drug on their own. The Moscow Department of Health has extensive experience in using the drug, as they supported the project from the start and clinical trials were conducted on the basis of Moscow centers. On our part, the release of the drug is going according to plan, the series are released into civilian circulation every month. Since the start of production, we have already processed more than 26 tons of plasma.

How to deal with weakness

"52 percent of the survey participants believe that they did not suffer from coronavirus, 26 percent are convinced that they had the disease, and tests confirmed this. And 13 percent said that they did not pay attention to the symptoms and saved on tests," Kirill Rodin, director for work with state authorities, cited the data of the new study. According to the sociologist, 79 percent of those who were ill experienced the consequences of the coronavirus: about half had a violation of taste and smell, and 17 had a deterioration in mood, anxiety and other psychological problems. A very revealing figure, experts say, concerns the attitude of Russians to their own rehabilitation: 80 percent of the respondents did not try to do anything. Scientists were also interested in those who taught the sick how to be treated. In the first place - doctors. They were approached by 64 percent of respondents who fell ill with covid. And the second, unfortunately, is confidently occupied by the Internet and "word of mouth" of neighbors and relatives: 21 percent of Russians resorted to them for answers to sore questions. A tenth of our citizens decided that "this is how everything will pass."

Do people know how to deal with post-COVID weakness? 58 percent answered that they did not know. Seven - suggested vitamins, two - the drug "Mildronate", popular among the people. "Okay, not plantain and garlic," commented Rodin.

Meanwhile, according to Veronika Shishkova, Head of the Department for the Prevention of Cognitive and Psychoemotional Disorders at the National Medical Research Center for Therapy and Preventive Medicine of the Russian Ministry of Health, asthenia is the hallmark of post-COVID. 75 percent of those who have been ill complain about it, and the post-covid syndrome can last more than a year. “Patients say: I sat down to eat, by the end of dinner I was so tired, as if I were loading something. I don’t want anything, I lie with my eyes closed.” This condition cannot be overcome without treatment. In addition to walking, breathing exercises, physiotherapy exercises, psychotherapy, doctors prescribe medications for severe asthenia. "They will enable the patient to become more active (get up off the couch)," Shishkova explained.

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