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Genetic research

Breakthrough in Cancer Gene Therapy: Establishing Clinical-Scale CAR-T Production in Kazakhstan

Strategic Insights

— 1 min read

In a groundbreaking study published in Biomolecules, researchers at the National Center for Biotechnology in Kazakhstan have successfully established a clinical-scale production of CAR-T cell therapy, a revolutionary treatment for cancer. The innovative approach, which involves the in-house production of lentiviral vectors and automated CAR-T cell processing, has overcome significant technical and infrastructural barriers in developing countries. This achievement paves the way for widespread access to advanced immunotherapies in regions like Central Eurasia.

Key Takeaways:

  • The study aimed to establish clinical-scale CAR-T production in Kazakhstan, a country with no prior experience in advanced cell and gene therapies.
  • Researchers implemented a complete CAR-T manufacturing pipeline, including in-house lentiviral vector (LV) production and automated CAR-T cell processing using the CliniMACS Prodigy system.
  • Two anti-CD19 CAR LVs were used, one modeled after FDA-approved Kymriah (4-1BB costimulation) and another replicating Yescarta (CD28 costimulation).
  • The vector produced locally achieved functional titers of 1.5 x 10[superscript]10 TU/mL after concentration.
  • Twelve clinical-scale CAR-T products were manufactured, exhibiting a memory-skewed T-cell phenotype.
  • Functional assessments revealed that CD28-based CAR-T cells produced significantly higher Th1 cytokines (IFN-g, TNF-a, IL-2; * * p* *
  • The study concluded that this work provides a scalable model of CAR-T therapy production in developing regions, suitable for clinical implementation using the hospital exemption framework.
  • The research aims to address critical gaps in access to advanced immunotherapies, including CAR-T, in the Central Eurasia region.

Statistics:

  • The study produced 12 clinical-scale CAR-T products, exhibiting a memory-skewed T-cell phenotype.
  • The vector achieved functional titers of 1.5 x 10[superscript]10 TU/mL after concentration.
  • CD28-based CAR-T cells produced significantly higher Th1 cytokines (IFN-g, TNF-a, IL-2; * * p* *

Sources:

  • Biomolecules, 2025,15(8):1166. (Biomolecules - http://www.mdpi.com/journal/biomolecules)
  • National Center for Biotechnology, Kazakhstan, Astana, Kazakhstan
  • National Center for Biotechnology Researchers Release New Study Findings on Cancer Gene Therapy (Introducing CAR-T Therapy in Kazakhstan: Establishing Academic-Scale Lentiviral Vector and CAR-T Cell Production). Immunotherapy Weekly. September 10, 2025; p 45.

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