Tissue Cross-Reactivity Studies

We hold a full range of tissues from various animal species. As outlined in FDA guidelines, we store an array of human tissues from multiple donors sourced from ethically approved tissue banks with full patient consent. Our commitment to new and improved pathology techniques has led to the generation of highly specific mechanistic drug action/tissue response data critical to worldwide regulatory filings.

For immunohistochemistry-based tissue cross-reactivity (TCR) studies, we provide efficiency of scale in full compliance with Good Laboratory Practice (GLP) regulations and interpretation of findings, and can represent you in presenting to the applicable regulatory agencies.

TCR Services

  • Preliminary studies
  • Definitive study
    • Three antibody concentrations
    • 37 tissues
    • Three different human subjects
  • Extensive controls
  • Slide evaluation and interpretation
  • Internal peer review
  • In vitro cross-reactivity
  • In vivo binding of test articles
  • Analysis of potential treatment-related effects
  • Potential immune complex deposition in kidneys
  • Immunophenotyping
  • Monoclonal preclinical safety
    • Human
    • Humanized
    • Chimeric
    • Murine
  • Clinical trial support
    • Entry criteria
    • Biomarker
    • Proof-of-principle
  • Final Report