Clinical Trial Therapeutic Monitoring

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, persistance
• 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

By 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