Interview with Dmitry Zemskov, Executive Director of JSC Biochemist, Rossiyskaya Gazeta

Biochemist JSC: 60 years of guarding the country's drug safety

Dmitry Nikolaevich, the Biochemist plant celebrated its anniversary in November. Congratulations to the factory staff on the round date! What achievements did the company celebrate on its 60th anniversary?

Dmitry Zemskov: Of course, this is an important milestone in the development of the company, which entered the history of the Russian pharmaceutical industry with the release of the first Soviet penicillin. 

Our company, which joined the plant in 2015, has made the preservation of traditions a priority of its development, laying an innovative method in their foundation. We have set a course for the creation and production of Russian antibiotics, both original and foreign analogues. The task is not an easy one, requiring an integrated approach, large financial, intellectual and labor resources. 

In four years, we have managed to revive an enterprise that had lost its former glory for a while. We have built new workshops, equipped them with state-of-the-art equipment, modernized production, and invited qualified specialists to the plant.
To date, the company's nomenclature portfolio has been updated by 60%. There are 100 modern and highly profitable drugs from various pharmaceutical groups at various stages of development and development, most of them are antibiotics. In 2019, more than 20 new medicines, including those that had never been produced in our country, received registration certificates. We plan to register another 40 in 2020. 

A gift for the anniversary date was a building with a new workshop for the production of active pharmaceutical substances, ready-made sterile preparations in liquid form and lyophilizate. Now they produce a popular broad-spectrum antibiotic in the form of lyophilizate. I would like to emphasize that our factory is the only manufacturer of this product in the country. In the near future, it is planned to launch the production of at least 11 types of medicines and three types of substances on the basis of new sites. Some of the drugs have already been registered with the Russian Ministry of Health. In the future, we will have one of the largest portfolios of modern medicines of various forms of release. 

Another of our pride is the hardware and software package for product serialization developed by the plant's specialists. As you know, starting from January 2020, the mandatory labeling system for medicines will start in the Russian Federation. We have independently created a system that issues an individual passport for each drug: information is sewn into the QR code about by whom, from what substance, when this product was released, at what time it entered the warehouse, and at what time it entered the trade. I would like to emphasize that the software for this digital system is Russian. The invention makes it possible to track all stages of the passage of medicines from the manufacturer to the end user, which protects Russians from counterfeiting and allows them to verify the authenticity of the manufactured drug. Any customer will be able to read all the information about the products using their mobile phone. 

Drug safety has been and remains one of our priorities.
When Biochemist launched the production of the first new generation of domestic antibiotics a year and a half ago, it was a real breakthrough. Has it been possible to fulfill the task of import substitution of a number of drugs previously purchased only abroad?
Dmitry Zemskov: After the crisis of the 90s, which hurt the domestic pharmaceutical industry, Russian drug manufacturers lost their positions. Until now, Russia buys substances for most antibacterial drugs from China, India, South Korea, Europe and the USA. Realizing the importance of the task set by the country's leadership to ensure drug safety, Biochemist was the first company in the Russian Federation to produce strategic drugs not from imported raw materials, but from its own, developed by the company's specialists. 

Today, we have mastered the industrial production of a full–cycle reserve antibiotic, vancomycin: it is used when other drugs are already powerless. By 2021, our scientists and technologists will prepare for the production of several more modern substances of glycopeptide antibiotics. Meanwhile, the technology of synthesis of antibacterial agents of the latest generations is being developed: oxazolidinones, lipopeptides, cephalosporins. 

New projects implemented by the company have aroused interest abroad. Tell us about the prospects of Biochemistry's international cooperation. 

Dmitry Zemskov: Today Biochemik is not only one of the leading players in the domestic pharmaceutical market, but also the largest exporters of medicines to the CIS countries and abroad.
In 2018, we opened a sales office in Vietnam, and this year we registered three antibacterial drugs there. Deliveries to this country will begin in 2020. 

The plant is currently undergoing a rather lengthy audit procedure with Latin America - there are preliminary agreements with Mexico and Chile. Among the promising areas, of course, is Southeast Asia. It is planned to supply about 20 medicines there, including antibiotics, cardiopreparations and drugs for neurology.
We pay special attention to these issues, because the development of the plant will largely depend on the competitiveness of our products in the global market. 

Today, the Russian pharmaceutical industry needs to restore not only production, but also human resources and scientific base. To solve these problems, "Biochemist" he established cooperation with the Moscow State University. Ogareva. Simultaneously with the launch of a new line of antibiotics, the Department of Chemistry and Technology of Physiologically active Substances was opened at the plant. The first graduates have already joined the company in the summer. How do you assess their level? Did the experiment pay off? 

Dmitry Zemskov: Training personnel for a new production is a very important task, and we are successfully coping with it. The students who came to the plant completed their studies under the professional retraining program at the Moscow State University, which we opened jointly with them. Ogareva department, organically joined our friendly team. The guys work as technologists, chemists, and chromatography engineers. We have high hopes for them in the synthesis of new domestic antibiotics. For this, Biochemistry has created all the conditions in accordance with modern international standards. About 40 more boys and girls continue their undergraduate studies at the university, and 20 of them are paid for by the company. 

By the way, this year, as part of the national project "Science", with the active participation of "Biochemist", the newest educational and scientific laboratory of chemical and pharmaceutical technologies was opened at the Institute of Physics and Chemistry of the Mordovian State University. Our factory has financed the purchase of the most modern equipment for it. Thanks to this, students can now reproduce and thoroughly investigate almost all stages of drug production - from the synthesis of the active substance to the production of the finished product. We are interested in highly qualified employees, so work in this direction will actively continue.
Today, our plant is rightfully one of the leaders in the Russian drug market, and we do not intend to stop there. The company is steadily developing and confidently looks to the future.