THE MEDSINTEZ PLANT: 20 years of work for the benefit of patients
This year marks 20 years since the nationally renowned Medsintez Plant in the Urals began manufacturing its first preparations. Today it is a modern full-cycle biotechnological enterprise that develops and manufactures pharmaceutical substances and drugs that meet international GMP and ISO standards. There are few pharmaceutical companies in the country that manufacture products meeting such high requirements. Thus, according to the Ministry of Industry and Trade of the Russian Federation, as of January 1, 2021, there were only 271 enterprises in Russia with a certificate of compliance with GMP standards.
Furthermore, the Medsintez Plant became the first pharmaceutical company in Russia to be awarded the Russian Government Quality Award by President Vladimir Putin. The Sverdlovsk enterprise achieved this within just four years of operation.
By that time, the Medsintez Plant was only producing infusion solutions and had not yet started production of insulin. The following year, the Plant's team managed to launch Russia’s first production of genetically engineered human insulin according to international GMP standards. Now there are several Russian companies producing infusion solutions and insulins, but the Medsintez team was able to go well ahead in its developments. Today, the highly qualified employees of the company are engaged in reproductive technologies and developing antiviral direction. But first things first.
STEPS INTO THE FUTURE
Until 2008, our country was completely dependent on imported supplies of insulin. Most patients with type 1 diabetes received a preparation whose ingredients were derived from pigs or cows and which had a number of disadvantages, such as allergic reactions, decreased sensitivity of the body to the action of the hormone itself (that is responsible for regulating blood sugar levels). Besides, imported insulin was expensive, and some patients with diabetes simply could not afford it.
The launch of production of genetically engineered human insulin at the Medsintez Plant was a turning point. This not only made it possible to return the country's market to domestic insulin producers, but also led to serious reduction in prices for foreign analogs of the preparation. Since then, Russian insulin is not inferior in quality and efficiency to foreign analogs, and in some cases even surpasses them. The Medsintez Plant took care to make it convenient for patients to administer insulin on their own. For example, the Urals plant has developed and patented the design of disposable and reusable injection pens, which allow dosing the preparation with high accuracy.
Since 2014, with the support of the Industrial Development Fund of the Russian Federation, the Medsintez Plant began to implement a project for import substitution of genetically engineered insulin substance and its analogues.
The project included establishing modern research laboratories for genetics and biotechnology and a pilot site for developing the substance production technology. The Plant began to actively develop biotechnologies. Thus, in September 2017, the Plant registered its own substance of Rosinsulin (genetically engineered human insulin); in December 2018 – the substance of Rosinsulin Aspart (analogue insulin); and in December 2020 – the substance of Rosinsulin Glargine (analogue insulin). Three years ago, the genetically engineered insuline Rosinsulin and analogue insulins – Rosinsulin Aspart R and Rosinsulin Glargine were included in the State Register of Medicines, and in 2021, Rosinsulin Glargine 300 was registered. An important event in 2023 for the Medsintez Plant was the registration of its own analogue drug Rosinsulin Glargine. Thus, the Plant has passed the full cycle from the beginning of developing the molecule to the production and registration of finished insulin medicinal products.
The production of insulin from own substance allows our country to completely abandon purchases from foreign companies, gaining independence from currency fluctuations, and therefore offering a stable price for the finished preparation in comparison with imported analogues.
The capacity of the insulin finished dosage forms production area is up to 10 billion international units per year, the Plant’s press service informed. As for insulin substance, the Plant is able to produce up to 200 kg/year. This can satisfy up to 100% of the Russian market demand. Today Rosinsulin is supplied all over the country. Therefore, one can definitely say that the Medsintez Plant provides reliable drug safety for Russian patients with diabetes. And for their pets as well.
In 2023, the Plant plans to produce the first Russian insulins for animals. The Medsintez team has consistently sought to achieve this for the last three years. In 2020, the Plant received a license for the production of drugs for veterinary use and, in 2022, despite geopolitical instability, a GMP compliance certificate for the site for the production of veterinary biotechnological preparations.
In an interview with Regions of Russia, Alexander Petrov, Chairman of the Board of Directors of Medsintez Plant LLC, explained that it took a long time to expand its products to veterinary drugs.
“We have been carrying out this project for a long time, it took three years of research: all this time we have tested the effect of human insulin on animals, calculated the concentration of the preparation, and worked out methods depending on an animal. And now we are ready to launch two insulins on the market – for cats and for dogs. The first batches will hit the market in the second half of 2023,” Mr. Petrov, Head of the Plant, said.
FIRST AMONG EQUALS
Since 2010, Alexander Petrov has headed the Medsintez Plant, that is, for about 13 years, the Ural plant has been exploring more and more new segments, gradually winning shares of the Russian market from imported manufacturers. Today, when foreign companies leave the Russian market, thanks in part to the Medsintez Plant, this process is painless.
“We make unique things,” the Head of the Plant Alexander Petrov says.
And one can well believe him: since 2018, the Medsintez Plant, in cooperation with iVFarma, has been engaged in the latest developments in the field of reproductive technologies. These developments help people cope with infertility. Such preparations are necessary to solve the demographic problem and increase the birth rate. In Russia, these projects are relevant and in demand, since the number of couples in need of assisted reproductive technologies (ART) is constantly growing. According to the Russian Ministry of Health, about 138,000 ART cycles were performed in 2020.
“We are the only plant in the Russian Federation that manufactures the recombinant human follicle-stimulating hormone (FSH) preparation Primapur, which is used in IVF procedures for female patients. We launched it in 2019 and we know that already over 10,000 children have been born in Russia to women who were treated with our preparation. By the way, for our Plant, this development gave boost to advancing a large area of drugs for women’s reproductive health. I can report that two more new drugs will soon appear on the market — Cetrorelix and recombinant human chorionic gonadotropin (HCG), which are also used in the IVF procedure. No one currently makes them in Russia, but we will soon fix this,” the Head of Medsintez Plant LLC said.
The substance and finished dosage form of Primapur, the first Russian recombinant follicle-stimulating hormone for the treatment of infertility, is included in the List of Vital and Essential Drugs. The Medsintez Plant developed and was the first in Russia to begin manufacturing the most convenient release form of FSH – disposable injection pens. The medicine is used in over 80% of medical centers specialized in the treatment of human infertility throughout Russia. The Medsintez Plant is ready to meet the annual demand for FSH preparations in Russia by 200%.
As for the production of other hormonal preparations necessary for IVF procedures, they are currently at the stage of preliminary work prior to submitting for registration to the Russian Ministry of Health. But Alexander Petrov, Chairman of the Board of Directors of Medsintez Plant LLC, notes with pride that these preparations are not a repetition of previous analogues that were made from human urine, but a unique Russian development of a hormone completely designed by Ural scientists.
During the pandemic, Ural scientists managed to gain worldwide fame when the preparation they developed turned out to be effective in treating COVID-19. In China, under the leadership of Yang Baofeng, Member of the Academy and President of Harbin Medical University, clinical studies were conducted, as a result of which the preparation Triazavirin, produced by the Medsintez Plant, was included in Chinese Guidelines for Using the Pharmacological Agents in the Treatment of Coronavirus Infection. As a result of cooperation, an international group of specialists was formed to promptly solve the tasks of developing programs and organizing studies of antiviral drugs in China and Russia.
Baffling as it may sound, due to the pandemic, numerous studies of the effect of Triazavirin were conducted and its high efficiency and safety in treating a new coronavirus infection have been established by large medical institutions in Russia. As a result of this research, Triazavirin was included in the recommendations of the Moscow Department of Health as an effective treatment for Covid, in the Standard for the Treatment of COVID-19 of the Russian Ministry of Defense, in the clinical protocol for treatment of patients with COVID-19 in healthcare organizations of the Moscow state health care system and other regulatory documents.
“We now see prospects for the Plant’s development in the antiviral area. We are currently working on reducing the dosage of Triazavirin without loss of effectiveness to make it more accessible to consumers. We have already conducted tests for ARVI, which showed that the amount of the preparation taken can be reduced to 100 mg. Moreover, we are working on new antiviral drugs. This is a big area, and we plan to move further in it,” Mr. Petrov explained.
Triazavirin is included in the federal clinical recommendations Influenza in Adults and ARVI in Adults of the Ministry of Health of Russia as a direct antiviral preparation. Work is also underway to bring to the market a pediatric form of Triazavirin. Multicenter clinical trials of Triazavirin in a dose of 100 mg for the treatment of ARVI in children aged 12–17 have been successfully completed. Now approval is pending for studies of the effects of the preparation in children aged 6 to 11.
PRIDE OF THE REGION
This year, from April 11 to April 14, the fourth International specialized exhibition-forum Healthcare of the Urals – 2023 was held in Ekaterinburg; 160 manufacturers and suppliers of medical products from 30 cities/towns of Russia participated. As part of the business program, Medsintez Plant LLC was named a leader and pride of the medical and pharmaceutical industry of the Sverdlovsk region. As Andrey Karlov, Minister of Health of the region, explained to Regions of Russia, this title generally reflects the attitude of both other pharmaceutical manufacturers and the regional authorities towards the Plant.
“Today, the products of the Medsintez Plant are in demand throughout the country; the production capacity of the enterprise is capable of meeting 100% of the region’s and the country’s demand for high-quality and affordable medicines. High standards of manufactured products, the creation and implementation of new technologies, constant scientific research and production focus on import substitution ensure the medicinal safety of Russia,” Andrey Karlov, Minister of Health of the Sverdlovsk Region, said.
It is fair to say that, to some extent, Medsintez Plant LLC has become a driver of development for the entire pharmaceutical cluster of the Urals. As the Ministry of Health informed Regions of Russia, the Medsintez Plant became the base organization for forming the Ural Biomedical Cluster and the Association of Medical and Pharmaceutical Manufacturers of the Sverdlovsk Region. To a great extent, the Plant contributed to uniting regional scientific, innovative, production, commercial and personnel potential within these organizations.
Today, most residents of the Sverdlovsk region know that the medicines they buy at the pharmacy are produced here.
“You see, we created Russian production from scratch in many areas – before us, the country did not have its own infusion solutions or insulin. We were the first and we are proud of it. We are proud that a production facility like ours, whose products are in demand throughout the country, exists in the Urals. We now have a team that wants to continue to create effective drugs for Russia and other countries, for all patients. And this is the most important thing,” Alexander Petrov, Chairman of the Board of Directors of Medsintez Plant LLC, shared in a conversation with Regions of Russia.
The Press Center of the Plant explains that the Plant has a very well-coordinated team; people have been working here for many years. Over 20 years of production, Medsintez has developed clear work rules that are strictly observed by all employees. If new staff fail to comply with these rules, they leave. Therefore, we can say that Medsintez, as a successful pharmaceutical manufacturer, has also turned into a leading scientific powerhouse.
“The quality of theoretical training at a university plays a big role, but every company operates according to established rules, and equipment and technologies have their own specifics, so you can only get the necessary practical skills by working at a company. For new personnel, the Medsintez Plant has implemented training programs on standard operating procedures and GMP and ISO requirements. New employees are assigned mentors who subsequently provide training for three months,” Mr. Petrov explained.
The Urals-based Medsintez Plant, which employs over 500 highly qualified specialists, is approaching its 20th anniversary with such achievements. It is obvious from the list of new preparations that are advanced for the whole country, the development of new areas of the pharmaceutical industry and plans for the future that 20 years is only the beginning for the Medsintez Plant. There is so much more to come. But, as Alexander Petrov, Head of Medsintez Plant LLC, has repeatedly said, “everything is being done for a Russian patient so that he or she is sure that tomorrow the medicines he or she needs will be available.”
Source: Regions of Russia magazine
