NCL-05: In Vitro Assessment of Nanoparticles for Their Potential to Cause Infusion Reactions

The Nanotechnology Characterization Laboratory (NCL) will analyze nanoparticles using a set of in vitro assays designed to identify possible infusion reactions. The three assays, complement activation, platelet aggregation, and inflammatory cytokine expression, combined will highlight the potential for a nanoparticle formulation to cause infusion reactions when administered to patients. Identification of this risk early in the development process can help mitigate potential safety concerns once the product reaches clinical trials. 

The three tests to be conducted for a nanoparticle sample include the following: 

  1. In vitro analysis of a nanoparticle’s ability to induce platelet aggregation and its effect on collagen-induced platelet aggregation. 
  2. In vitro analysis of a nanoparticle’s ability to induce the classical, alternative, and common pathways of the complement activation, formation of the terminal complex, and levels of the complement factors H and I. 
  3. In vitro analysis of a nanoparticle’s ability to induce secretion of pro-inflammatory cytokines in human peripheral blood mononuclear cells.

All tests will utilize freshly drawn human blood from three individual donors, collected in accordance with all appropriate laws and regulations. Nanoparticle samples will be prepared according to the manufacturer’s instructions and as appropriate to the assay services requested. Results will be analyzed and provided in the form of a report. Sufficient basic consultation with a subject matter expert is included with the service.