Recombinant and analogue human insulins API production

Production capacity: up to 200 kg of the API per year enables to satisfy up to 100 % Russia’s necessities of insulin drugs. 

The «Import-Substituting Production of Recombinant and Analogue Insulin from Proprietary Substance project» has been under way since 2014 and supported by the Industry Development Fund of the Russian Federation.

The Medsintez Plant plans to manufacture API of recombinant and analogue insulin for subsequent use in its own production of finished dosage forms.

Own insulin APIs were registered: In September 2017 – «Rosinsulin» (RHI), in December 2018 – the analogue insulin «Rosinsulin aspart» and in December 2020 the analogue insulin – «Rosinsulin glargine» (100 IU/ml).

Finished dosage forms were registered: in December 2020 – «Rosinsulin Medsintez» and «Rosinsulin aspart R», in December 2021 - «Rosinsulin glargin 300 Medsintez» (300 IU/ml), in March 2023 – «Rosinsulin glargine» (100 IU/ml).

Today, the Medsintez Plant is implementing the full-cycle production of the entire line of products of genetically engineered human insulin Rosinsulin and its analogue forms — Rosinsulin Aspart R and Rosinsulin Glargine from its own APIs.

Thus, the enterprise has passed the full cycle from the beginning of developing the molecule to the production and registration of finished insulin medicinal products.

The production of insulin from its own substance allows us to completely abandon purchases from foreign companies, gain independence from currency fluctuations, and therefore offer a stable price for the finished preparation in comparison with imported analogues. 

For the project, the following have been created at the «Medsintez» plant:

• A modern R&D lab for genetics and biotechnology (2014)
• A pilot zone (for developing a technology for the production of recombinant drugs, including the API of analogue insulin forms) (2015)
• RHI API industrial production with capacity up to 200 kg/year (2017-2024)

Recombinant human follicle-stimulating hormone API production

Production capacity: 150 grams of API per year (CHO cells), which is eight times higher Russia's domestic market demand.

Since 2018, Medsintez has implemented another biotechnological project for the production of the latest development in the field of reproductive technologies in cooperation with iVPharma: the enterprise has produced the substance of recombinant follicle-stimulating hormone and produced the first Russian drug for the treatment of human infertility – Primapur. It is used in the in vitro fertilization (IVF) procedure to induce the growth of follicles in the ovaries. The preparation is successfully used in clinics throughout Russia.

A fully Russian drug; it went through all stages, from the development and creation of a pharmaceutical substance to the release of a finished dosage form, exclusively in the Russian Federation. Primapur® is included in the list of vital drugs.

The Russian-made FSH preparation is necessary for modern medicine in the Russian Federation on the way to overcoming the reproductive problems of the population. Within the framework of the Federal Law of November 21, 2011 No. 323-FZ "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation", citizens are widely provided with affordable infertility treatment using the IVF procedure.

High-tech Russian production at the Medsintez plant ensures the world-class quality and safety of manufactured medicines. At the same time, the domestic production of FSH does not depend on fluctuations in exchange rates, which means it offers a stable price for the finished drug in comparison with imported analogues.

Solving the issues of import substitution, the enterprise is developing other hormonal drugs, used in a complex of assisted reproductive technologies, such as recombinant human chorionic gonadotropin and human gonadotropin-releasing hormone antagonists Cetrorelix and Ganirelix. At the moment, the production of such drugs in the Russian Federation is especially important in order to ensure the availability of IVF treatment methods and the uninterrupted supply of drugs to the medical centers of our country.

Recombinant human albumin production

Production capacity: enables to satisfy up to 100 % Russia’s necessities of these product.

In 2024 the full-cycle production of the world's first registered recombinant human albumin for widespread use in medicine was launched.

The active pharmaceutical ingredient is made from a recombinant engineering strain of Pichia Pastoris with high expression of human albumin and obtained through fermentation, preparative separation, coarse and fine purification, including affinity chromatography, ultrafiltration, and concentration. The quality of the active pharmaceutical ingredient and finished dosage form is determined in accordance with international requirements.

If necessary, this production area is capable of producing any import-substituting preparations based on monoclonal antibodies.