According to statistics, approximately 10 million Russian residents are diagnosed with diabetes. It has been established that such an ailment is primarily associated with a violation of the process by which pancreatic cells produce their own insulin. In this case, the patient is completely disturbed by the normal metabolism. The solution is daily self-administration of insulin into the body. The current course of the state program is aimed at ensuring that all vital medicines are created at domestic enterprises. Insulin production is also developing in this vector.
Actual situation in Russia
At one time, a recommendation was issued by the World Health Organization, which literally says that each country with a population of more than 50 million people should open its own factories for the manufacture of this drug. Otherwise, diabetics may experience periodic difficulties in acquiring the medication they need that is not acceptable. In Russia, only one pharmaceutical company managed to fully establish its own insulin production facilities - Geropharm.
Today, two types of domestic products are sold on the market. Insulin is supplied either as a substance or as a medicine. Recent political changes and the introduction 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, on the territory of the city of Pushchino, it is planned to create a whole complex that will produce any types of hormones.
Import Substitution Options
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, for 15 years, Russian-made insulin is quite capable of occupying a share of 30 to 40 percent of all hormones sold in the country. The first attempts at such reforms began in Soviet times, but the drug produced in those years was of animal origin, and its degree of purification left much to be desired.
The reorganization partially failed in 1990 for the simple reason that serious financial problems arose in the country. Today, small industries are gradually starting to gain momentum. Many companies in Russia attempted to deliver the product stably to pharmacies, but at the same time used a foreign substance. In the current realities, it is too early to hope for a complete substitution of imported insulin.
Recent changes and progress
One of the new production was planned to open in 2017. The cost of the final product was supposed to be lower than that of foreign analogues. Thus, the company planned to achieve healthy competition. The program was designed to solve many difficulties associated with diabetes in the country, as well as improve the financial situation.
In addition, they plan 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 substance every year.
The state plans to debug the production of hormones of both ultrashort and long-term action. In total, there are four positions that will soon have to fill the pharmacy counters. Various forms of the product will be offered to the end user, including vials, syringes, disposable and reusable pens, as well as special cartridges.
Quality control of products
Scientists have found that the most optimal and non-side-effect hormone is genetically engineered insulin. Its physiological properties and qualities almost completely repeat those of the natural variant. Of course, first of all, tests and tests were carried out, because in the production of insulin quality control is put above all. Scientific research has proven a good positive effect from the use of the drug, a sufficient level of lowering glucose in the blood and the complete absence of any allergic manifestations with prolonged exposure.
Experts concluded that the transition of patients to new domestic drugs should not cause any discomfort or ailment. Also, before the production of insulin, additional tests of the Rinsulin R and Rinsulin NPH preparations were carried out. In this case, the researchers did not notice any significant differences from foreign analogues. For end consumers, the most convenient was called the fact that they would not have, however be it, to change the usual routine of taking and dosing the hormone, as well as the method of the procedure itself.
Description of production technology
The process includes all the basic stages of manufacturing any biotechnological product. The final insulin is crystalline. Then it is used to develop injection solutions that are intended as a diabetic of the first and second type. In total, seven main stages can be distinguished in the technology of insulin production, listed in the list below.
- Preliminary. The preparation and purification of water, air and industrial premises are carried out, equipment is sterilized. Then the primary chain of molecules is created through chemical synthesis.
- Preparation of nutrient solutions and cell culture. The necessary genes are introduced into living matter to produce the desired compound.
- The suspension cultivation process. Cells are grown in special bioreactors.
- Isolation of culture. Water is separated, and the cells are sedimented and filtered to maintain maximum integrity.
- Chromatographic purification of the substance. A variety of methods are used, including frontal, gel permeation and anion exchange.
- Getting protein culture. An unprepared insulin molecule is being synthesized.
- Freeze-drying from the oven. Also at this stage, the product is checked for compliance with the standard, packaging, labeling and shipping.
The benefits of domestic insulin
Scientists plan to use a special technique in the manufacture of the drug. While technology is being prepared for large-scale production of a genetically engineered product, at the same time, construction of new insulin production plants in Russia is underway. Thus, the infrastructure is currently undergoing a stage of active growth and development.
Domestic insulin will be manufactured according to the scheme with a full cycle, which is an innovation in world practice. The substances will either have to be imported from foreign partners, or produced on their own. Most likely, both options will be combined as necessary. Current research is being conducted at the Moscow Institute of Bioorganic Chemistry, 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 advanced technologies. For example, for the production of insulin in Russia, methods of separation, gel filtration, enzymatic treatment, renaturation and chromatographic purification are tested. Modern equipment at the already operating Biotechnology plant allows packaging of 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. At the same time, all personnel are carefully selected and pass the appropriate test of practical skills and theoretical knowledge of the subject.
Classification of the Russian drug
Despite the special emphasis on the genetic engineering option in manufacturing, the domestic technique allows you to move in other directions. For example, it is allowed in the production of insulin to use its human or biosynthetic genesis. Scientists are also exploring the prospect 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 patient intake. The frequency of daily use will vary from two to six times. Thanks to such insulin therapy, a complete imitation of the physiological process of the release of this hormone in the human body will occur.
The future of domestic production
Experts in the industry said that in the near future, replace the method of using the drug with diabetics. If today almost always the injection of a substance occurs through an injection, then in the future this option will be changed to special plasters or an artificial pancreas. Developments, of course, are still only on paper, but now insulin production is actively developing.