Clinical Trial Therapeutic Monitoring

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, 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

State-of-the-Art

ISO7 cGMP Manufacturing Suites


Proven

Logistics & Warehousing Operations


Extensive

Flow Cytometry & Analytical Infrastructure

Life Technologies Attune™ flow cytometer

Life Technologies Attune™ flow cytometer