How It's Done: Russian Journalists Were Shown The Production Of Pharmaceutical Substances In France

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How It's Done: Russian Journalists Were Shown The Production Of Pharmaceutical Substances In France
How It's Done: Russian Journalists Were Shown The Production Of Pharmaceutical Substances In France

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How it's done: Russian journalists were shown the production of pharmaceutical substances in France

The Russian pharmaceutical industry is 90% dependent on the import of substances, and their own production is a matter of national security. But setting up such production is a very difficult task. Russian journalists were convinced of this with their own eyes, having visited the Oril Industry plant, which is part of Servier Group, which for the first time in its long history opened its doors to foreign media.

How it's done: Russian journalists were shown the production of pharmaceutical substances in France
How it's done: Russian journalists were shown the production of pharmaceutical substances in France

Photo: Servier Group /

The state program for the development of the pharmaceutical industry assumes the creation by 2024 of a completely Russian production of drugs from the list of vital and essential drugs, including the synthesis of molecules of active pharmaceutical ingredients. So far, the domestic pharmaceutical industry is 90% dependent on the import of substances, and their own production is a matter of national security. However, setting up such production is a very difficult task. Russian journalists were convinced of this personally by visiting the Oril Industry plant, which is part of Servier Group, which for the first time in its long history opened its doors to foreign media.

The production of active pharmaceutical ingredients (APIs) is the first and foremost step in drug development, requiring incredible purity, precision and precision in every process. There are few such industries in the world: for high-tech chemical synthesis of molecules, production capacities and production sites with a sufficient amount of energy resources and infrastructure are needed that meet GMP requirements.

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Servier is a good example of a combination of production of finished forms, substances and R&D (research and development, an analogue of the Russian abbreviation R&D). The Oril Industry fine chemical synthesis plant located in Normandy produces 98% of the pharmaceutical substances for the company's original drugs, which are produced in France and eight other countries, including Russia.

Oril Industry is a chemical plant that supports 45 R&D projects and produces 1,800 tons of pharmaceutical substances annually. The plant has been operating since 1960 and employs more than 800 employees at two production sites - in the cities of Bolbeck and Buckler.

From unripe orange to venotonic

Before the excursion to the workshops where API is produced for Detralex (this well-known drug in Russia received the Platinum Ounce in 2018 in the OTC Drug of the Year nomination and the SmartPharma® Awards 2019 in the Venotonic of the Year nomination), journalists were given overalls and footwear, helmets and goggles. The safety requirements in the chemical industry must be strictly observed.

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The strategic site works around the clock, stopping only once a year for ten-day preventive maintenance. The raw material for the API is the plant extract hesperidin contained in the peel of dried unripe oranges. An enterprise producing 1.3 tons of substances for Detralex requires 1.5 tons of hesperidin powder obtained from 25 tons of unripe oranges per year.

All operations, parameters and problems are reflected on monitors in the process control center. After careful analysis, the raw materials are loaded into the first reactor, where they are mixed with solvents supplied through separate pipelines. Then the solution enters the next reactor, where, as a result of a change in the double bond in the chemical formula, the hesperidin molecule is converted into a drug molecule. The process consists of three transformations. The purpose of the first is to protect the molecule before the second transformation, during which the molecule is oxidized and a double bond is created, during the third, temporary protection is removed from the molecule.

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The following stages after chemical synthesis: separation, crystallization of the substance (purification from impurities), washing, filtration and drying, taking place in different reactors. The process is completed by micronization (crushing of crystals with compressed air from 42 to 2 microns). Finally, the resulting substance is packed in large bags or drums. All stages of production of one batch take 48 hours. For each batch, laboratory tests are carried out, pending the results of which the product is stored in the warehouse.

R&D

The production process is preceded by extensive research and development work, in which 25% of the company's turnover is reinvested annually. Russian journalists were shown the plant's holy of holies - an R&D center in which 20% of the company's employees work. As explained by the director of Oril Industry, Karol Roban, the research center works in two directions: it develops processes and analytical tests for the production of new complex molecules required for preclinical and clinical research, and also accompanies all stages of main production.

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Each active ingredient is unique, she says, and each must have individual analytical characteristics and operating instructions. The R&D department supports 45 research projects in several therapeutic areas: cardiovascular diseases, diabetes mellitus, oncology, autoimmune diseases, chronic venous insufficiency, neurology and psychiatry.

The new molecules themselves, in the amount of several milligrams, are initially obtained by scientists using techniques that are difficult to reproduce on an industrial scale (for example, you cannot pour something into a reactor, like into a test tube - you need a pump). And already at Oril Industry, they develop cost-effective technologies for the safe production of new molecules, select reagents, achieve the stability of the production process and the stability of the substance itself (depending on temperature, humidity, etc.). Based on the results of studying the bioavailability of a substance, the optimal size of crystals is determined.

Today, 33 original Servier medicines are at various stages of development. However, the question of the Mednews correspondent about the API remained unanswered for them: the process of creating a substance is one of the most guarded secrets in the world.

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The journalists were shown the work of pilot models of industrial installations, as well as how the quality of the substance is checked in practice. The presence or absence of impurities in it is determined by two methods. This is liquid chromatography (separation of mixture components using high pressure and fine-grained sorbents). And Raman spectroscopy, which allows you to identify the constituent substances by the reflected spectrum, without contacting them and without destroying the packaging.

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Green chemistry

The synthesis of pharmaceutical substances is a complex chemical production, and it is very important to monitor its impact on the environment. Equipping pharmaceutical production facilities with reliable treatment facilities requires huge investments.In Servier, based on the principles of green chemistry, 10% of investment in production development is devoted to environmental protection and safety measures, for example, modern wastewater treatment plants and other important projects. The Oril Industry plant uses a large amount of biodegradable solvents, and more than 70% of production waste is recycled. The water at the inlet and outlet of the enterprise is analyzed daily according to 15 parameters. An innovative purification plant operates at the production site, the volume of which corresponds to the station required for a city with a population of 40 thousand inhabitants.

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“The quality standard is important to us. The production of our own substances gives us independence from suppliers and allows us to fully control the entire process in order to be confident in the quality of our medicines. Such control is part of the company's global policy,”said Antoine Beiver, Director for Central and Eastern Europe and Canada, answering Mednews's question about why the company works only with its own APIs.

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