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Efficacy & Safety Assessment

AcceGen offers comprehensive in vivo efficacy assessment services, utilizing xenograft tumor models established on their proprietary C-NKG mouse with depleted T, B, and NK cells. This model is ideal for evaluating the therapeutic activity of drugs, including cell therapy products, as well as for constructing human immune system models. In addition, we possess expertise in constructing syngeneic mouse tumor models and maintain an extensive tumor model database, providing customers with a wide range of options for in vivo efficacy assessment.

Service case

Three days after tumor modeling using Nalm-6 cells, mice were intravenously injected with PBS, T cells (1×107 cells), and CAR-T cells (1×107 cells) for observation and recording. The results demonstrated a significant prolongation of the survival period in mice injected with CAR-T cells, accompanied by a delayed tumor growth.

Figure 1. The process of antibody production.

AcceGen possesses vast experience in vitro drug efficacy evaluation, particularly in assessing the efficacy of cell therapy drugs such as CAR-T and CAR-NK. Our evaluation includes key indicators such as cell killing activity, killing specificity, cell proliferation ability, and cytokine secretion capacity. Drawing upon our proficiency in cell drug efficacy evaluation, AcceGen is well-equipped to meet diverse testing requirements in this field.

Application

  • Evaluate the potential safety and efficacy of a therapy in a single study, providing valuable information about its effects on both aspects.
  • Increase efficiency and cost-effectiveness by assessing safety and efficacy together, reducing the time and resources required for therapy development.
  • Provide a comprehensive view of the therapy’s benefits and risks, identifying potential trade-offs and offering a more complete understanding.
  • Support regulatory agencies in evaluating the therapy’s safety and efficacy, helping to obtain regulatory approval.
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