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
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Life Technologies Attune™ flow cytometer