CDMO
Introduction:

Pracgen has a variety of GMP grade cell production platforms to provide customers with CAR-T, CAR-NK, CAR-M and other cell production services, which are widely applied in cell therapy.

T cell, also known as T lymphocyte, is a kind of human white blood cells. Derived from bone marrow hematopoietic stem cells, it grows mature in the thymus, and then migrates to the human blood, lymph and surrounding tissues and organs to achieve immune function. Scientists have activated T cells through genetic engineering technology and fitted them with CAR (Tumor chimeric antigen receptor) to transform T cells into CAR-T. CAR-T uses CAR to identify tumor cells in vivo and releases a large number of effector factors through immune action to effectively kill tumor cells and further treat malignant tumors.

NK cell is natural killer cell, which has cytotoxic and immunomodulatory functions. NK cells modified with CAR structure are able to efficiently identify and kill tumor cells by releasing killing mediators and inducing apoptosis of target cells. However, compared with CAR-T, CAR-NK does not produce severe cytokine storm during treatment,thanks to the natural characteristics of NK cells. Therefore, CAR-NK is safer than CAR-T in clinical use. Second, CAR-NK has a shorter survival time in vivo than CAR-T, conducive to protection against many unknown risks associated with the long-term presence of genetically modified immune cells in the body. However, many challenges exist in the preparation of CAR-NK. Compared with T cells, the introduction of the target gene into NK cells is more challenging, and the in vitro amplification technology of primary NK is still immature.

Macrophage is “huge” phagocyte. Phagocyte refers to some cells with phagocytosis function in human body, such as monocytes and granulocyte. Macrophage is vital in the elimination of foreign antigens by immune system. CAR modified M cells can be used to treat cancers.

Procedure:

GMP gradecell process development and production (with CART cells as an example)

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Advantages:
  • Advantages

    C+A class production environment

     No cross contamination, close production and disposable production consumables

     Cell process development, optimization and validation

     Three batches of continuous production with GMP grade process

     Functional analysis of CAR-T in vivo and in vitro

     Validation and stability study of analytical methodology

     Quality standard formulation and release

     IND complete data support

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