Clinical Trial Therapeutic Monitoring

Clinical Trial Therapeutic Monitoring

Customized Programs Tailored to the Product and Clinical Indication

 

At KBI Biopharma, we are at the forefront of the rapidly-evolving field of cell therapy, providing a wide range of cutting-edge services to support the development and commercialization of next-generation cell-based treatments.

At KBI our therapeutic monitoring programs are custom-tailored to the product & clinical indication leveraging multiple methods.

Aims of a program:

Safety, Acute Affects

• Product engraftment, persistence
• Product-related immunological response (cellular, soluble factors)

Longitudinal

• To identify marker(s) that predict a patient’s response to therapy
• To identify cell type(s) that are responsible for therapeutic success

For example, methods may include:

• In vitro cellular bioassays (anti-tumor cytotoxicity, product differentiation, expansion, tumor site accumulation)
• Multi-color Flow cytometric analysis (surface, intracellular, cell signaling)
• Cytokine analysis via ELISA, ELISPOT, or Bead-Based Multi-cytokine array
• Cell activation, Cell cycle monitoring, Proliferation, Apoptosis

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