Currently, there are about 10 million people diagnosed with diabetes in Russia. This disease, as you know, is associated with a violation of the production of insulin by pancreatic cells, which are responsible for the metabolism in the body.

In order for the patient to live a full life, he needs to regularly inject insulin every day.

Today, the situation is such that more than 90 percent of the medical products market is made up of foreign-made drugs - this also applies to insulin.

Meanwhile, today the country faces the task of localizing the production of vital drugs. For this reason, today all efforts are directed to ensure that domestic insulin becomes a worthy analogue of world-famous manufactured hormones.

Release of Russian insulin

Behind last years Geropharm is the leader in the development of genetically engineered drugs in the country.

It is she, the only one in Russia, who produces domestic insulins in the form of substances and medicines. At the moment, short-acting insulin Rinsulin R and intermediate-acting insulin Rinsulin NPH are produced here.

However, most likely, production will not stop there. In connection with the political situation in the country and the imposition of sanctions against foreign manufacturers, the President Russian Federation Vladimir Putin instructed to fully engage in the development of insulin production and to inspect existing organizations.

It is also planned to build a whole complex on the territory of the city of Pushchino, where all types of hormones will be produced.

Will Russian insulin replace foreign-made drugs?

As experts say, at the moment Russia is not a competitor in the global market for the production of insulin. There are three main producers large companies- Eli-Lilly, Sanofi and Novo Nordisk. However, over the course of 15 years, domestic insulin will be able to replace about 30-40 percent of the total amount of the hormone sold in the country.

The fact is that the Russian side has long set the task of providing the country with its own insulin, gradually replacing foreign-made drugs.

The production of the hormone was launched back in the days of the USSR, but then insulin of animal origin was produced, which did not have high-quality purification.

In the 1990s, an attempt was made to organize the production of domestically engineered insulin, but the country ran into financial problems and the idea was put on hold.

All these years Russian companies tried to produce different kinds insulin, but foreign products were used as a substance. Today, organizations began to appear that are ready to release a completely domestic product. One of them is the above-described company Geropharm.

• It is planned that after the construction of the plant in the Moscow region, the country will produce modern views drugs for diabetics, which in quality can compete with Western technologies. The modern capacities of the new and already operating plant will make it possible to produce up to 650 kg of the substance in one year.
• The new production will start in 2017. At the same time, the cost of insulin will be lower than foreign analogues. Such a program will solve numerous problems in the field of diabetology in the country, including financial ones.
• First of all, manufacturers will be engaged in the production of an ultrashort and long-acting hormone. Over the course of four years, a complete line of all four positions will be released. Insulin will be produced in vials, cartridges, disposable and reusable syringe pens.

Whether this is true will be known after the process is launched and the first reviews of new drugs appear.

However, this is a very lengthy process, so the inhabitants of Russia should not hope for an early import substitution.

What is the quality of the hormone of domestic production

The most suitable and non-causing side effect for diabetics is genetically engineered insulin, which corresponds in physiological qualities to the original hormone.

To test the effectiveness and quality of short-acting insulin Rinsulin R and intermediate-acting insulin Rinsulin NPH, a scientific study was conducted, which made it possible to demonstrate a good effect of lowering blood glucose in patients and the absence of an allergic reaction during long-term treatment with drugs Russian production.

In addition, it can be noted that it will be useful for patients to know that this information is extremely important today.

The study involved 25 diabetics aged 25-58 years who were diagnosed with type 1 diabetes mellitus. 21 patients had a severe form of the disease. Each of them daily received the required dosage of Russian and foreign insulin.

1. The indicator of glycemia and glycated hemoglobin in the blood of patients with the use of a domestic analogue remained approximately at the same level as with the use of a hormone of foreign production.
2. The concentration of antibodies also did not change.
3. Including ketoacidosis, an allergic reaction, an attack of hypoglycemia were not observed.
4. The daily dosage of the hormone during the observation period was administered in the same volume as at the usual time.

In addition, a study was conducted to evaluate the effectiveness of lowering blood glucose levels using Rinsulin R and Rinsulin NPH preparations. There were no significant differences in the use of insulin of domestic and foreign production.

Thus, scientists came to the conclusion that diabetics can be transferred to new types of insulin without any consequences. At the same time, the dosage and mode of administration of the hormone are preserved.

In the future, it is possible to adjust the dosage based on self-observation of the state of the body.

Use of Rinsulin NPH

This hormone has an average duration of action. It is rapidly absorbed into the blood, while the rate depends on the dosage, method and area of ​​​​administration of the hormone. After the drug is administered, it begins its action in an hour and a half.

The greatest effect is observed between 4 and 12 hours after it enters the body. The duration of exposure to the body is 24 hours. The suspension is white, the liquid itself is colorless.

The drug is prescribed for type 1 and type 2 diabetes mellitus, it is also recommended for the disease in women during pregnancy.

Contraindications include:

• Individual intolerance to the drug to any component that is part of insulin;
• The presence of hypoglycemia.

Since the hormone cannot cross the placental barrier, there are no restrictions on the use of the drug during pregnancy.

During breastfeeding, it is also allowed to use the hormone, however, after childbirth, it is necessary to monitor the level of glucose in the blood and, if necessary, lower the dosage.

Insulin is administered subcutaneously. The dosage is prescribed by the doctor, depending on the specific case of the disease. The average daily dose is 0.5-1 IU per kilogram of body weight.

The drug can be used both independently and in conjunction with the short-acting hormone Rinsulin R.

Before injecting insulin, it is necessary to roll the cartridge at least ten times between the palms so that the mass becomes homogeneous. If foam has formed, it is temporarily impossible to use the drug, as this may lead to an incorrect dosage. Also, you can not use the hormone if it contains foreign particles and flakes adhering to the walls.

An open drug can be stored at a temperature of 15-25 degrees for 28 days from the date of opening. It is important that insulin be stored away from sunlight and extraneous heat.

In case of overdose, hypoglycemia may develop. If the decrease in blood glucose is mild, the undesirable phenomenon can be eliminated by ingesting sugary foods containing in large numbers carbohydrates. If the case of hypoglycemia is severe, a 40% glucose solution is administered to the patient.

To avoid this situation, after that you need to eat high-carb foods.

Use of Rinsulin R

This drug is a short-acting insulin. By appearance it is similar to Rinsulin NPH. It can be administered subcutaneously, as well as intramuscularly and intravenously under the strict supervision of the attending physician. The dosage should also be agreed with the doctor.

After the hormone enters the body, its action begins in half an hour. The maximum efficiency is observed in the period of 1-3 hours. The duration of exposure to the body is 8 hours.

Insulin is administered half an hour before a meal or a light afternoon snack containing a certain amount carbohydrates. If only one drug is used in diabetes mellitus, Rinsulin R is administered three times a day, if necessary, the dosage can be increased up to six times a day.

According to statistics, approximately 10 million Russian residents have been diagnosed with diabetes. It has been established that such an ailment is primarily associated with a violation of the process of production of its own insulin by the cells of the pancreas. In this case, the patient's normal metabolism is completely disrupted. The solution is to manually inject insulin daily into the body. Current exchange rate state program aims to ensure that all vital drugs are created at domestic enterprises. The production of insulin also develops in this vector.

Current situation in Russia

At one time, the World Health Organization issued a recommendation that literally says that every country with a population of more than 50 million people should open their own factories for the manufacture of this drug. Otherwise, diabetics may experience periodic difficulties in acquiring the medicine they need, which is not acceptable. In Russia, only one pharmaceutical company managed to fully establish its own insulin production capacity - Geropharm.

Today, the market sells two types of domestic products. Insulins are supplied either in the form of substances or as medicines. Recent political developments and the imposition of sanctions on the import of foreign products have obliged the government to order that higher production capacities be deployed as soon as possible. In addition, it is planned to create a whole complex on the territory of the city of Pushchino, which will produce any kind of hormones.

Import substitution opportunities

At the moment, it is definitely too early to talk about the full-fledged withdrawal of the domestic product and its competition with large Western companies. However, within 15 years, Russian-made insulin is quite capable of taking a share of 30 to 40 percent of all hormones sold in the country. The first attempts at such reforms began back in the days of the USSR, but the drug produced in those years was of animal origin, and the degree of its purification left much to be desired.

The reorganization partly failed in 1990 for the simple reason that the country was in serious financial trouble. Today, small-scale production is gradually beginning to gain momentum. Many companies in Russia have attempted to supply a stable product to pharmacies, but at the same time they used a foreign substance. In the current realities, it is too early to hope for a full replacement of imported insulin.

Recent changes and progress

One of the new productions was planned to open in 2017. The cost of the final product was supposed to be lower than that of foreign counterparts. Thus, the company planned to achieve healthy competition. The program was designed to address many of the country's diabetes-related issues, as well as improve the financial situation.

In addition, they are going to build their own insulin production plant in the Moscow region, where the product will not be inferior to imported samples in terms of quality. Currently, this factory successfully produces about 650 kg of the substance every year.

The government plans to debug the manufacture of hormones, both ultrashort and long-acting. In total, there are four positions that will soon have to fill the pharmacy counters. The end consumer will be offered various forms of the product, including vials, syringes, disposable and reusable pens, as well as special cartridges.

Checking the quality of products

Scientists have found that the most optimal and side-effect-free hormone is genetically engineered insulin. Its physiological properties and qualities almost completely repeat those of the natural version. Of course, first of all, tests and tests were carried out, because in the production of insulin, quality control is put above all else. Scientific research proved a good positive effect from the use of the drug, a sufficient level of lowering blood glucose and the complete absence of any allergic manifestations during prolonged exposure.

The experts concluded that the transition of patients to new drugs of domestic production should not cause any discomfort and ailments. Also, before the production of insulin, additional tests of Rinsulin R and Rinsulin NPH preparations were carried out. In this case, the researchers did not note any significant differences from foreign analogues. For end users, the most convenient thing was that they would not have to, however, change the usual routine of taking and dosage of the hormone, as well as the method of carrying out the procedure.

Description of production technology

The process includes all the main stages of manufacturing any biotechnological products. The final insulin is crystalline. It is then used to develop injectable solutions that are intended for type 1 and type 2 diabetics. In total, seven main stages can be distinguished in the insulin production technology, as listed below.

1. Preliminary. Preparation and purification of water, air and industrial premises equipment is sterilized. The primary chain of molecules is then created through chemical synthesis.
2. Preparation of nutrient solutions and cell culture. The necessary genes are introduced into living matter to produce the required compound.
3. Suspension cultivation process. The cells are grown in special bioreactors.
4. Identification of culture. Water is separated and the cells are sedimented and filtered to maintain maximum integrity.
5. Chromatographic purification of the substance. A variety of methods are used, including frontal, gel permeation and anion exchange.
6. Obtaining a protein culture. An unfinished insulin molecule is synthesized.
7. Freeze drying oven. Also at this stage, the compliance of the product with the standard, packaging, labeling and shipment are checked.

Advantages of domestic insulin

Scientists plan to use a special technique in the manufacture of the drug. While the technology for large-scale production of a genetically engineered product is being prepared, at the same time, the construction of new plants for the production of insulin in Russia is underway. Thus, the infrastructure is currently undergoing a stage of active growth and development.

Domestic insulin will be produced according to a full-cycle scheme, which is an innovation in world practice. Substances will either have to be imported from foreign partners, or produced on your own. Most likely, both options will be combined as needed. Current research is carried out on the basis of the Moscow Institute of Bioorganic Chemistry of the Russian Academy of Sciences in Obolensk. It is worth noting that this organization does not establish mass production, but only studies the issue for the subsequent increase in capacity in the industry.

Features of manufacturing in Russia

It is also planned to introduce some progressive technologies. For example, for the production of insulin in Russia, methods of separation, gel filtration, enzymatic treatment, renaturation and chromatographic purification are being tested. Modern equipment at the already functioning plant "Biotechnologies" allows you to pack finished products in special multi-dose disposable containers, which are commonly called cartridges.

Experts assure that they follow all international standards in the production of medicines. All personnel are carefully selected and subject to appropriate testing of practical skills and theoretical knowledge of the subject.

Russian drug classification

Despite the special emphasis on the genetic engineering option in the manufacture, the domestic technique allows moving in other directions. For example, it is allowed to use its human or biosynthetic genesis in the production of insulin. Scientists are also exploring the prospects of extracting the right substances from pigs, whales and cattle.

The resulting insulin will differ, for example, in the duration of exposure, which can be directly related to the required frequency of administration by the patient. The frequency of daily application will vary from two to six times. Thanks to such insulin therapy, a full-fledged imitation of the physiological process of secretion of this hormone in the human body will occur.

The future of domestic production

Experts in the industry said that in the near future plans to replace the way the drug is used by diabetics. If today almost always the administration of a substance occurs through an injection, then in the future this option will be changed to special patches or an artificial pancreas. Developments, of course, are still only on paper, but insulin production is already actively developing.

On May 20, 2016, at the Sanofi-Aventis Vostok plant (Orel), in the presence of the Governor of the Oryol Region V. Potomsky, the production of insulin validation series was launched latest generation.

A new life-saving drug for the treatment of diabetes mellitus (DM), the latest generation basal insulin developed by Sanofi, was registered in the US and EU in 2015. Approved in more than 30 countries around the world. It has a smoother and more stable action profile and therefore fewer side effects, as well as flexibility in use, which can help patients achieve better disease control.

latest generation insulin

The effectiveness and safety of the drug has been proven in clinical studies involving more than 3500 patients:

Triple units of insulin glargine per ml
More flexible schedule administration (within 3 hours before or 3 hours after the usual administration)
Stable and long-term control of blood glucose levels over 24 hours allows you to use the drug once a day
Cardiovascular and general security proven on insulin glargine in long-term studies.

Strategic production site

Sanofi-Aventis Vostok is the first and currently the only full-cycle pharmaceutical plant in Russia* for the production of modern insulins, Sanofi's contribution to the modernization program pharmaceutical industry RF "Pharma-2020" and increasing the availability of innovative drugs for Russian citizens.

* Except for the production of the pharmaceutical substance.

In 2015, the Sanofi-Aventis Vostok plant successfully passed the European inspection and received the GMP certificate of the European Agency for medicines. This will allow the export of insulins to the EU countries to begin in the second half of 2016. All drugs manufactured at the Sanofi-Aventis Vostok plant are identical in terms of quality, efficacy and safety to those manufactured at the Frankfurt plant.

High-tech production

The Sanofi-Aventis Vostok plant was built in full compliance with international standards GMP:

The total area of ​​the territory is 5.8 hectares
The total area of ​​the building is 12700 m2
Warehouse area - 5224 m²
Quality management systems - more than 20 physical, chemical and microbiological tests
Staff - 197 highly qualified employees, certified in the Sanofi insulin production center in Frankfurt.

Investment in production

Growth in production volume in 2014-2015 - 24%
Production capacity Sanofi-Aventis Vostok plant – 7.5 billion units of insulin per year
Market share of insulin - 30%

Diabetes is a socially significant disease

In 2013–2014 the largest epidemiological study of the prevalence of diabetes mellitus in Russia has been conducted to date:

26,000 people aged 20-79 from 63 regions of Russia
20% of the population are at risk
5.44% of the population have DM
54% of subjects diagnosed with type 2 diabetes were unaware of their disease
20% of people with newly diagnosed type 2 diabetes need immediate treatment

WITH anofi in Russia

largest pharmaceutical company in Russia
Presence - over 45 years (since 1970)
Staff - more than 2000 employees
More than 10 large social programs
Clinical studies - 128 clinical centers, 2215 patients.

Social projects in the Oryol region

2011 - stage of the international bike ride for people with diabetes
2012–2014 – charitable program "Chance for Life" in support of women with breast cancer
Since 2015 - personal support program for patients with diabetes

Insulin-dependent diabetes is a disease that requires lifelong therapy. From the presence or absence insulin literally the life of the patient depends.

Diabetes It is officially recognized as a non-infectious epidemic and, according to the WHO, occupies the third place in terms of spread after cardiovascular and oncological diseases. There are 200 million people with diabetes in the world, which is already 6% of the adult population of the world. More than 2.7 million of them live in our country. Much of their life depends on what is produced within these walls.

The Medsintez plant has been operating in Novouralsk, Sverdlovsk, since 2003. Today it satisfies 70% of the needs of everything Russian market insulin. So I took the opportunity to take a short tour of this enterprise with pleasure and interest.

And the first thing that surprised me was the "matryoshka" buildings. Inside the production "non-cleaning" shop there is another one - "clean". Of course, in the common corridors everywhere there are mirrored floors and cleanliness. But the main action takes place there, behind the glass windows. Zavod Medsintez LLC, established in 2003, is part of the NP Ural Pharmaceutical Cluster. Today, the cluster unites 29 firms of various profiles with a total staff of more than 1,000 people. The plant currently employs over 300 people.

Guests inside the entrance ordered, even though we were packed in overalls. I had to look through the windows. Feminine dominates inside manual labor. Something is laid out and packed.

In a nutshell, or rather in one picture, then here:

INSULIN PRODUCTION SCHEME

And now to the point. In 2008 at the Medsintez plant with the participation of the governor Sverdlovsk region E.E. Rossel, the opening of the first in Russia industrial production finished dosage forms of genetically engineered human insulin in accordance with the requirements of GMP EC (certificate TUV NORD No. 04100 050254/01).

The capacity of the production site is up to 10 billion IU per year, which makes it possible to satisfy up to 70% of the needs of the Russian insulin market.

The production is located in a new building with an area of ​​more than 4000 m². Includes a complex clean rooms with an area of ​​386 m², including premises of cleanliness classes A, B, C and D.

Technological equipment from leading world manufacturers has been installed at the production facility: BOSCH (Germany), SUDMO (Germany), GF (Italy), EISAI (Japan).

However, the substance that is necessary for the production of the drug, previously had to be purchased in France. In order to produce the substance ourselves, it was necessary to develop our own bacterium. It took Ural scientists four years to do this - they patented their strain in May 2012. Now it's time to start production.

In the meantime, we were shown the holy of holies - it is with this substance that the production chain begins.

On the other side of the glass are bioreactors. Everything is automated and people are only on this side.

“Live” employees can only be seen further down the technological chain. Water preparation shop.

The drugs themselves are moved from shop to shop exclusively on conveyors.

Here the girls collect packages and put them on a conveyor belt. The conveyor approaches the border of the "sterile" zone and drops the packages into a special tray. Together with the packages, a powerful stream of air is knocked out of the tray. Bacteria and other filth "against wool" do not get through.

Then he will have to run a few meters along the "non-sterile" zone to the next "sterilizer". There they are laid out on pallets and sent to this hefty cleaner. Also deserted, or rather, only one operator works. The trolleys roll automatically on rails.

Now the last section -. Insulin is ready to go to the consumer. There are not many people either, even the boxes are laid out by a terrible machine on servos.

Construction is underway in Novouralsk new building, which should fully cover the need for insulin substance for the whole country. Moreover, part of the products will be delivered abroad - agreements on this have already been signed.

The new building will be operational in a few months. Medsintez expects to receive the first batch of completely Russian insulin in the first half of 2013.

The cost of the project for the construction of a new building is 2.6 billion rubles. The workshop area is 15 thousand square meters. m, of which 2 thousand are laboratories. Most of the equipment will be purchased in Germany. The capacity of the plant should be 400 kg of substance per year. This, according to experts, is 75 kg more than the demand of the Russian Federation.

Today, about 2 million Russians need daily insulin intake. A package of a foreign drug costs about 600 rubles, a domestic one costs about 450-500 rubles. After the implementation of the project, the cost should be reduced to 300 rubles. In this case, the Russian budget could save about 4 billion rubles.