Apheresis-Based Leukapheresis as a Key Step in CAR-T Cell Manufacturing: First Experience in Kazakhstan

Introduction: CAR-T cell therapy is the newest and most effective treatment method for resistant forms of B-cell hematological malignancies; however, it has until now remained unavailable in Kazakhstan. The first and critically important step in the manufacturing of CAR-T products is apheresis-based leukapheresis — a procedure that determines the quality of the starting cellular material for genetic modification of T lymphocytes. In the Republic of Kazakhstan, this procedure was performed within the framework of a national scientific and technical program for the implementation of CAR-T therapy.
Objective: To study the parameters of apheresis-based leukapheresis and to characterize the cellular composition of the obtained mononuclear cell concentrate in order to assess its suitability as starting material for the manufacturing of CAR-T products.
Materials and Methods:  At the Department of Cell Technologies of the Scientific and Production Center of Transfusiology (Astana), 12 leukapheresis procedures were performed in 7 healthy donors and 5 patients with oncohematological diseases. An automated separator Spectra Optia (Terumo BCT, USA) was used with the Mononuclear Cell Collection program. The volume of processed blood, procedure duration, product cellularity, CD3⁺ T-cell content, and sterility were assessed.
Results: All 12 procedures were completed without complications. The mean volume of processed blood was 9549.5 mL (1.0–2.6 blood volumes), and the mean duration was 230.8 min. Cell yield varied: total leukocyte count ranged from 6.5×10⁹ to 32.1×10⁹ (mean 14.4±8.0×10⁹), and CD3⁺ T-lymphocyte content ranged from 129.1×10⁷ to 1629.7×10⁷ cells per dose. Products from all participants were sterile and deemed suitable for CAR-T cell manufacturing. Differences were noted between the donor and patient groups; however, due to the small sample size, statistical analysis was not performed.
Conclusions: Apheresis-based leukapheresis yields a cellular concentrate that fully meets the requirements for initiating the manufacturing of CAR-T products. This work represents the first standardized protocol in Kazakhstan for obtaining clinically significant cellular material for CAR-T cell manufacturing and lays the foundation for the development of national quality criteria.
Funding: Program-Targeted Funding of the Ministry of Health of the Republic of Kazakhstan BR25293293 "Implementation of chimeric antigen receptor (CAR)-T cell therapy technology for hematological tumors into practical healthcare."

CAR-T Cell Therapy Apheresis-Based Leukapheresis Mononuclear Cells CD3⁺ Lymphocytes Onomatology

Bekmakhanova B, Abdrakhmanova S, Ospanova M, Baltabayeva T, Zhangaziyeva K, Turabayeva B, et al. Apheresis-Based Leukapheresis as a Key Step in CAR-T Cell Manufacturing: First Experience in Kazakhstan. Oncology, Nuclear Medicine and Transplantology. 2026;2(3, Suppl. 1):onmt_A39. https://doi.org/10.63946/onmt/19299