Импортозамещение в фармакологии: подтверждено качество первого отечественного бета-пропиолактона для вакцин

The 99.6% purity drug will meet the needs of pharmaceutical companies for the reagent

The Engineering Chemical-Technological Center (ECTC), in collaboration with Tomsk State University, has confirmed the quality of the first domestic beta-propiolactone (BPL), an important reagent for vaccine production. Tests have shown a record purity of the substance at 99.6%.

Beta-propiolactone is used as a virus inactivator — it makes viral particles safe while preserving their structure for the formation of an immune response. Vaccines against influenza, hepatitis A, rabies, coronavirus, and a number of animal infections are based on it.

The need for a Russian analogue arose after 2022, when supplies of imported BPL ceased. As a result, pharmaceutical companies faced shortages and a sharp increase in prices. Chemists at TSU developed a synthesis technology and transferred it to the ECTC, where a pilot plant was launched at the small-tonnage chemistry site in Tomsk. The full cycle of domestic production started in 2024.

In October, specialists from the ECTC and TSU certified the sample using a specially developed method. In addition to purity analysis, tests are ongoing to determine the stability of the substance at various temperatures, which will guarantee its reliability in long-term storage. The production capacity of the center allows the production of up to 1000 liters of reagent per year — this volume is sufficient to fully meet the needs of the Russian pharmaceutical market.

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Sources
TASS

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