Pharmaceutical Technologies and Packaging, No. 3 (324) 2025

Last year, at the IX All-Russian GMP Conference with international participation, the Pharmstandard Group of Companies announced an investment plan totalling 25 billion rubles. These funds are slated for manufacturing development and R&D through 2027. 

THE COUNTRY’S FIRST LARGE-SCALE PRODUCTION OF COAGULATION FACTOR VIII 

One of the group’s strategic priorities is the production of human plasma-derived products. Pharmstandard is the first and, so far, the only manufacturer that has succeeded in establishing large-scale production of Coagulation Factor VIII in the form of a lyophilisate in our country. The plant of JSC Pharmstandard-UfaVITA manufactures the Russian product Eitoplasm using highly purified human blood plasma cryoprecipitate. The lyophilisate for solution for intravenous administration is available in 500 IU and 1,000 IU vials. Before the appearance of the Russian product, 100% of the demand was met exclusively by foreign analogues.

To produce plasma-derived products, a new workshop covering over 1,500 square metres has been built at JSC Pharmstandard-UfaVITA in accordance with modern international standards. Additionally, another production line is scheduled to be commissioned in the near future.

In the production of final plasma-derived medicinal products, the Ufa enterprise uses four different purification mechanisms, including chromatographic purification. A number of purification steps are performed several times to obtain a pure product. During production, a strong attention is paid to the viral safety of the products, which includes rigorous testing of all raw materials for viral contaminants.

Among its numerous control stages, JSC Pharmstandard-UfaVITA implements two main stages focused solely on ensuring viral safety: solvent/detergent treatment aims to inactivate enveloped viruses by disrupting their lipid membrane, while the thermal inactivation method achieves viral degradation under thermal exposure. In the manufacturing process, conditions are created to ensure that temperature does not affect the target protein, Factor VIII.

The quality control stages, production processes, technological and laboratory equipment used, as well as the engineering infrastructure of JSC Pharmstandard‑UfaVITA are fully qualified and validated. This provides ongoing assurance of the quality of the biological products manufactured by the company.

PHARMSTANDARD INCREASES PRODUCTION OF HUMAN NORMAL IMMUNOGLOBULIN AND ALBUMIN

Pharmstandard Group of Companies has another important project underway in the Republic of Belarus, focused on the production and supply of human blood plasma-derived medicinal products. Since 2022, Pharmstandard has owned a 70 percent share in the authorised capital of LLC Daliompharma. The company, based in Nesvizh, specialises in the production of medicinal products and drug substances derived from human plasma. Specifically, this site handles the entire production process for highly demanded medicinal products in our country, such as human normal immunoglobulin (in dosages of 50 mg/mL and 100 mg/mL) and human albumin (in all required dosages registered by the Ministries of Health in the Republic of Belarus and the Russian Federation). The plant is certified according to Good Manufacturing Practice (GMP) of the Eurasian Economic Union.

At LLC Daliompharma, when manufacturing human plasma-derived medicinal products in accordance with the recommendations set out in Decision No. 110 of the Eurasian Economic Commission Council dated 15 July 2022, chromatographic purification methods are also used. Furthermore, two main antiviral stages are implemented to ensure the viral safety of the released products, thereby eliminating the risk of patient infection with HIV, viral hepatitis B and C, and parvovirus.

The Russian Government approved the concept of increasing the blood plasma procurement for medicinal products manufacture in our country by Decree No. 291‑r in 2023. According to the concept, and based on the assessment by the Expert Council of the Ministry of Health of the Russian Federation, as well as average European consumption values for plasma-derived medicinal products, the estimated annual need of the Russian healthcare system for albumin is 31.3 tons, and for immunoglobulin, it is 8.1 tons.

FUTURE GOALS

Pharmstandard, a reliable partner to the government in implementing strategic healthcare initiatives, announced its readiness to expand the production and supply of the essential and vital medicinal products it manufactures. Pharmstandard stated that since 2023, the Daliompharma facility has been undergoing continuous modernisation of its production capabilities and laboratory unit. This initiative involves further automating manufacturing processes and equipping both the plant and laboratories with state-of-the art equipment that has proven itself in the world’s largest pharmaceutical companies. The modernisation project specifically includes the upgrading of the analytical laboratory and the PCR laboratory, and the construction of a new microbiological laboratory. The work that has been completed will enable the company to significantly increase its raw material processing volume per production cycle in the short term, and by 2026, reach a capacity of processing up to 300 tons of blood plasma annually.

However, the company also points to objective factors that are hindering the rapid development of human plasma-derived product manufacturing. The development and implementation of plasma-derived medicinal products is a capital-intensive process. At one point, the economic sanctions imposed on our country resulted in limited or entirely halted supplies of certain standard samples and reagents from unfriendly countries. At present, this issue can be resolved.

The raw materials issue will remain relevant for the time being. For example, cryoprecipitate is used as a raw material for Coagulation Factor VIII in our country. In Russia, it is produced by blood transfusion centres, but this amount is not enough for industrial output.

According to a concept approved by the Russian Government aimed at increasing blood plasma collection for the production of pharmaceuticals, Russia plans to produce up to 1.8 million litres of plasma annually by 2030. From 2026, a single market of the EAEU will effectively be established. In this regard, Pharmstandard proposes lifting restrictions on the export of human blood plasma for processing within the Union State — specifically, in the Republic of Belarus — on the condition that the finished medicinal products derived from human blood plasma are subsequently imported into the Russian Federation.

Currently, Federal Law No. 125-FZ dated 20 July 2012, “On Blood Donation and Its Components” (as amended on 25 December 2023) (hereinafter referred to as the “Law of the Russian Federation on Donation”), restricts the use of blood and its components for the manufacturing of medicinal products and medical devices. In accordance with the Law of the Russian Federation on Donation, specifically concerning domestic supply, the possibility of providing manufacturers of medicines and medical devices with donor blood and its components is defined (Article 17.1). Additionally, the key terms for entering into agreements regarding the collaborative development of infrastructure for entities involved in the circulation of donor blood and/or its components have been outlined (Article 26.1 of Law of the Russian Federation on Donation). The provisions of Federal Law No. 204-FZ dated 28 June 2022, amended Article 18 of the Law of the Russian Federation on Donation. These amendments, on the one hand, established provisions on the possibility of importing plasma into the territory of the Russian Federation for the purpose of manufacturing medicines and/or medical devices. However, they simultaneously imposed a ban on the export of plasma produced in the Russian Federation for fractionation to other countries.

Lifting the legislative ban on the export of blood plasma to the Republic of Belarus would expand opportunities to provide patients with medicinal products manufactured in the Union State from blood plasma collected in the Russian Federation, according to the Pharmstandard Group of Companies.