The Medsintez plant is an innovative pharmaceutical enterprise that manufactures vital and major medicines. Today, the plant's developments are focused on the area, which is among the most demanded ones by the Russian healthcare system, namely creating drugs for diabetes. Read on to find out how the company operates on the modern biotech market.

 

20 years ago, the Russian market of insulin was divided by three major international pharmaceutical corporations. They dictated prices for insulin drugs. Between 1993 and 2003, the prices tripled. So did the Russian budget expenditures on this kind of drugs. In 2008, the Medsintez plant launched Russia's first production of genetically engineered human insulin in full compliance with international Good Manufacturing Practice standards. This not only allowed domestic insulin manufacturers to come back to the market but also caused a serious decline in prices for exported analogues of the drug.

 

Why was it so important? The number of patients with diabetes mellitus grows rapidly all over the world. In Russia alone, the figure has surpassed 4.3 million. More than one million of these people are insulin dependent. Providing the diabetics with drugs is one of the most socially responsible and budget-consuming sectors of Russian healthcare. Today, however, the problem of import substitution of genetically engineered human insulin on the domestic market has been 100% resolved due to such enterprises as the Medsintez plant.

 

 

“Before Medsintez launched its insulin production, the Russian budget had been spending huge extra funds on buying drugs of foreign origin. In 2008, the plant produced Rossinsulin, and prices for its foreign analogues dropped by 30%. We pressed foreigners on our market. Since then, foreign insulins have almost the same price levels as the Russian ones,” said Alexander Petrov, Chairman of Medsintez Board of Directors.

In 2003, a similar price drop occurred as Medsintez was just starting its business. The plant's first product was infusion solutions that Russia had to buy from foreign companies before. As soon as domestic infusion solutions appeared, prices for imported drugs dropped.

 

“Our import substitution policy is implemented like this: we search the market to find out what is in demand now and then launch Russian production of these products,” said the head of the enterprise. For example, the plant has developed a project of disposable and reusable syringe pens, which allow high-precision dosage of the drug. “Since the main problem with diabetes patients is abnormal blood sugar levels, dosing accuracy is the key factor to achieve the norm securely. No “residual droplet” remains in the Medsintez syringe pen, while no overdose is possible too,” said Alexander Petrov.

 

 

In 2018, the Ural plant marketed all types of finished dosage forms of insulin used in modern antidiabetic therapy: in cartridges and vials, in pre-filled disposable and reusable syringe pens. Along with standard preparations of genetically engineered insulin of short-term and longer-term action, Medsintez ensured full import substitution of two-phase insulins. Unable to compete, international manufacturers had to abandon the Russian pharmaceutical market. On the other hand, the plant managed to achieve high product quality comparable to that of foreign analogues.

 

In 2007, the Medsintez plant became the first pharmaceutical company in Russia to be awarded the Russian Government Prize in the field of quality by President Vladimir Putin. At every drug manufacturing stage, the plant has a multi-level quality control in place. It includes the entrance inspection of raw materials, in-process inspection of semi-finished products, release control of drugs and continuous monitoring of production facilities. All research is carried out in three licensed labs of the plant: microbiological, chromatographic as well as check and analytical ones.

 

All of them are equipped with modern tools and equipment. The Medsintez staff has excellent expertise and is trained by accredited educational institutions on a regular basis to improve their skills. The pharmacists improve their practical skills not only in Russia but also abroad, at partner production enterprises, such as Bayer in Germany. Along with the laboratory quality control, the plant monitors all drug manufacturing and storage processes for compliance.

“No batch of drugs can reach patients unless approved by an authorized person who is personally responsible for the quality and safety of marketed drugs. The plant has some boards of authorized persons in place. These specialists possess all the necessary competencies and obligatory state certification. This helps us maintain an extremely high product quality level. Over more than a decade, we have been proving that the drugs we produce are not inferior to those of foreign companies. Our quality control system just will not allow a poor-quality drug to enter the market,” explained Aleksandr Petrov.

 

 

Supported by the Industry Development Fund of the Russian Federation, Medsintez creates insulin substance from its proprietary producer bacteria. The project started in 2014, when a modern research lab of genetics and biotechnology was established at the plant. Only few pharmaceutical enterprises in Moscow and St. Petersburg can boast of such labs. In 2015, a pilot site to develop an insulin substance manufacturing technology was opened. In 2016, the Industry Development Fund supported the production and granted the plant a low-interest loan issuing 183 million roubles at only 5% per annum.

 

Medsintez was the first full-cycle biotechnology company in the Ural region. It not only produces but also develops medicines. This looks like this: initially, a new producer organism is designed on a computer using special-purpose software and only then is reproduced in a real lab. The technology is scaled in the pilot production workshop, and it is only then that the main production is launched.

 

“We have established a site for the commercial production of the substance, purchased technological equipment, mounted it and adjusted for serial production. As for now, the Rosinsulin and analogue Rosinsulin-Aspart pharmaceutical substances are on the drug directory of the Russian Ministry of Health. Some finished medicines based on the substances have already passed clinical trials. Currently, another analogue insulin substance, Glargin, is undergoing the registration too,” said Alexander Petrov.

 

By the end of 2020, Medsintez will use these substances in its production of finished medicines. This will enable us to stop purchasing from foreign companies and to become independent from exchange rate fluctuations and sanctions. As a result, finished insulins in Russia will be 15-20% cheaper than imported ones. Also, hospitals and pharmacies will have uninterrupted supplies of Russian insulins. Even in 2014, when sanctions were imposed, the company grew steadily creating new products and technologies., Therefore, today, it is able to provide patients with high-quality domestic drugs, irrespective of any international economic risks. Medsintez will keep manufacturing drugs in the most convenient and familiar finished dosage forms for patients: in cartridges and syringe pens. The plant plans to produce up to 400 kg of the substance of genetically engineered human insulin and insulin analogues annually, which means high drug safety for Russian diabetics.