Аңдатпа
Introduction. Automated leukapheresis is the initial step in the production of CAR-T cell products and provides a concentrated fraction of mononuclear cells used for subsequent isolation, genetic modification, and expansion of T-lymphocytes. Despite the widespread introduction of CAR-T therapy into clinical practice, the questions of standardization of the leukapheresis procedure and assessment of the quality of the initial cellular material are still insufficiently investigated, especially in the organization of academic CAR-T cell production. Objective. To evaluate the quality of the mononuclear cell concentrate obtained by automated leukapheresis and determine the possibility of its use as the initial material for CAR-T cell production within the implementation of the national scientific and technical program of the Republic of Kazakhstan. Materials and methods. A pilot study was conducted at the Scientific and Production Center for Transfusiology. The study included 12 participants: 7 healthy donors and 5 patients with oncohematological diseases. Automated leukapheresis was performed using the Spectra Optia® system (Terumo BCT, USA) with the Mononuclear Cell Collection program. The technical success of the procedure, main technological parameters, cellular composition of the obtained product, number of viable CD45⁺/CD3⁺ T lymphocytes, and results of microbiological control were evaluated. Results. All automated leukapheresis procedures were completed in full without technical complications. The obtained mononuclear cell concentrates were suitable for subsequent CAR-T cell production. The mean volume of processed whole blood was 9549.5 mL, and the mean duration of the procedure was 230.8 min. The number of leukocytes in the obtained products ranged from 6.5×10⁹ to 32.1×10⁹ cells per dose, with a mean of 14.4±8.0×10⁹. The CD3⁺ T-lymphocyte content ranged from 129.1×10⁷ to 1629.7×10⁷ cells per dose, with a mean of 607.2±526.6×10⁷. Sterility of the cellular product was confirmed in all cases. Conclusion. The obtained results confirm the possibility of obtaining a mononuclear cell concentrate by automated leukapheresis that meets the requirements for subsequent CAR-T cell production. The developed algorithm for performing the procedure, laboratory quality assessment, and transfer of the cellular product can be used for further standardization of the collection of initial cellular material and development of a national platform for academic CAR-T cell production. Keywords: CAR-T cell therapy, automated leukapheresis, mononuclear cell concentrate, CD3⁺ T lymphocytes, cell therapy.