The Moscow-based R-Opra plant (part of the R-Pharm Group) has transitioned to the industrial production of sterile dosage forms. The facility has mastered the aseptic production technology required to create complex anti-tumor drugs. The first product to come off the new line is a targeted drug based on eribulin.
Technological Barrier Cleared
The transition to aseptic production is a landmark event for the manufacturing site. Unlike terminal sterilization, aseptic processing requires maintaining absolute sterility at all stages of the technological process: from component preparation and solution filtration to the filling of ampoules or vials.
“The Moscow plant ‘R-Opra’ has started the production of drugs for which special strict aseptic requirements are provided. They are used for severe and chronic diseases, for example, oncopathologies. The conditions created at the enterprise provide for multi-level quality control.”
— Anatoly Garbuzov,
Minister of the Government of Moscow, Head of the Department of Investment and Industrial Policy
The plant’s management emphasized the importance of launching the new line for strengthening the independence of the Russian pharmaceutical industry.
“Mastering sterile production represents an important step in strengthening the site’s production competencies. This innovation not only expands the possibilities for localization of drugs critical for clinical practice but also contributes to reducing dependence on external supplies in various therapeutic areas.”
— Elena Lyutina,
Production Director at R-Opra Plant
First in Series: Eribulin
The launch product of the new line is a drug based on eribulin. This is a complex microtubule dynamics inhibitor that is part of the “gold standard” therapy for several malignancies.
Key indications:
- Breast Cancer: Locally advanced or metastatic (in patients who have previously received at least one chemotherapy regimen).
- Liposarcoma: Unresectable soft tissue sarcoma (after anthracycline therapy).
In the near future, the portfolio of sterile oncology drugs produced at the site will be expanded by two more items, which will strengthen the capital’s drug security.
Offset Economy
Production is deployed at the Alabushevo site (Technopolis Moscow SEZ) as part of an offset contract. This public-private partnership mechanism guarantees the investor (R-Pharm) long-term sales of products for the needs of Moscow healthcare in exchange for creating high-tech production within the region.
Source: Press Service of the Department of Investment and Industrial Policy of Moscow
