2024 Author: Howard Calhoun | [email protected]. Last modified: 2023-12-17 10:16
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 producing 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. The current course of the state program is aimed at ensuring that all vital drugs are created at domestic enterprises. Insulin production is also developing in this vector.
Current situation in Russia
At one time, the World He alth 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 intermittentdifficulties in acquiring the medicine they need, which is not acceptable. In Russia, only one pharmaceutical company managed to fully establish its own insulin production capacities - Geropharm.
Today, two types of domestically produced product are sold on the market. 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 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, butused a foreign substance. In the current realities, it is too early to hope for a full replacement of imported insulin.
Latest 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 he althy competition. The program was designed to address many of the country's diabetes-related issues, as well as improve the financial situation.
In addition, in the Moscow region are going to build their own plant for the production of insulin, where the product will not be inferior to imported samples in terms of quality. At present, this factory successfully produces about 650 kg of the substance every year.
The state 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 user will be offered various forms of the product, including vials, syringes, disposable and reusable pens, as well as special cartridges.
Checking the quality of manufactured 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 were carried out andtesting, because quality control is paramount in the production of insulin. A scientific study has proven a good positive effect of the drug, a sufficient level of lowering blood glucose and the complete absence of any allergic manifestations with prolonged exposure.
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 schedule for 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 product. 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.
- Preliminary. Preparation and purification of water, air and industrial premises are carried out, equipment is sterilized. The primary chain of molecules is then created through chemical synthesis.
- Preparation of nutrient solutions and cell culture. ATliving matter, the right genes are introduced to produce the required compound.
- Suspension cultivation process. Cells are grown in special bioreactors.
- Isolation of culture. Water is separated and 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.
- Obtaining a protein culture. An unfinished insulin molecule is being synthesized.
- Freeze drying oven. Also at this stage, product compliance 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 factories 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 their 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 should be noted that this organization does not organize massproduction, 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 Biotechnology plant allows packaging finished products in special multi-dose disposable containers, which are commonly called cartridges.
Specialists assure that they follow all international standards in the production of medicines. All personnel are carefully selected and undergo appropriate testing of practical skills and theoretical knowledge of the subject.
Classification of the Russian drug
Despite the special emphasis on the genetically engineered option in manufacturing, 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.
Insulin received will differ, for example, in the duration of exposure, which can be directly related to the required frequency of intake by the patient. The frequency of daily application will vary from two to six times. This insulin therapy willa full-fledged imitation of the physiological process of secretion of this hormone in the human body.
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.
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