At the end of 2023, Pharmstandard-UfaVITA JSC (Ufa) reached full production of the Plasma-Derived Coagulation Factor VIII under trademark Eightoplasm. The company will be able to manufacture up to 370 million IU per year. 

Pharmstandard-UfaVITA is the first Russian large-scale manufacturer of the Plasma-Derived medicinal product for haemophilia A treatment. The manufacture was launched at the end of 2022. Currently, the pharmaceutical complex gears up to supply the product under the programme 14 high-cost nosologies. Up to now, the need was 100% covered by imported medications.

Eightoplasm is produced at the plant in Ufa with full-cycle technology using highly purified cryoprecipitate, with control as per international standards at each stage. The drug is available in the form of a lyophilizate for solution for intravenous administration, 500 or 1,000 IU in vials. It is indicated for bleeding treatment and prevention in patients over 12 years old with congenital haemophilia A or acquired coagulation factor VIII deficiency.

Eightoplasm is manufactured using chromatographic purification methods, which allow to obtain a high purity blood coagulation factor VIII drug, as well as modern methods of virus inactivation, completely eliminating the risk of viral infections transmission through the drug product. In this case, a number of purification steps are performed several times to obtain a pure product.

Special attention is paid to the viral safety of the drug during the manufacturing process. For this purpose, the starting raw materials are tested at different production stages: the raw material producers, Italian and Dutch companies, control the plasma pooling and the resulting cryoprecipitate. Then, each batch of cryoprecipitate and the finished drug product undergo multi-sample inspection at the enterprise in Ufa.

Eightoplasm efficacy and safety were studied as part of the international multicentre clinical trial, which proved the possibility of using the drug both for spontaneous and post-traumatic bleeding prevention, as well as for blood loss reduction during surgeries of varying degrees of complexity in patients with severe haemophilia A. According to expert opinion, the obtained research results are not inferior to foreign counterparts [1] [2] [3], including for surgical interventions [4] [5].

International study completion as per the requirements of the European Medicines Agency (EMA) allows Pharmstandard to subsequently initiate registration of the drug “Eightoplasm” abroad.

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[1] I. L. Davydkin, T. A. Andreeva, V. Yu. Zorenko, V. N. Konstantinova et al. Efficacy and safety of the Octofactor for the preventive treatment of patients with severe and moderate haemophilia A (data of the 1st part of a phase II–III clinical trial). Clinical pharmacology and pharmacotherapy. 2013. 2013; 12 (2): 29-37.

[2] V. V. Voytsekhovsky, T. V. Yesenina, E. A. Filatova, K. M. Mishkurova et al. Use of the Octofactor for the preventive treatment of patients with haemophilia A. Issues of haematology/oncology and immunopathology in paediatrics, 2020; 19 (2): 122‒128. DOI: 10.24287/1726-1708-2020-19-2-122-128.

[3] S. A. Volkova, D. A. Kudlay, M. D. Bogomolova, E. A. Sirotkin et al. Locally produced recombinant blood coagulation factors: technological prerequisites for creation and clinical studies results. Haematology/oncology and immunopathology issues in paediatrics. 2021; 20 (4): 209–213. DOI: 10.24287/1726-1708-2021-20-4-209-213.

[4] V. E. Soldatenkov, O. V. Soldatenkova, K. A. Komissarov, V. V. Burakov et al. Experience of minor surgical interventions in patients with haemophilia A administered with Efmoroctocog alfa. Materials of the All-Russian scientific and practical conference with international participation “Current issues of haematology and transfusiology”, dedicated to the 90th anniversary of the Russian Research Institute of Haematology and Transfusiology. Bulletin of Haematology. 2022; 18 (2): 87.

[5] V. Zorenko, T. Polyanskaya, E. Karpov et al. Clinical case of sequential major joints arthroplasty followed by removal of the elbow joint pseudotumor in a patient with severe haemophilia A. The Physician. 2019; 30 (6): 80–84. DOI: 10.29296/25877305-2019-06-19.