Tissue cross-reactivity (TCR) studies are key in the development of monoclonal antibodies and other related biologics to ensure that the experimental antibody or biologic does not bind to epitopes other than the target site as this could lead to treatment-related toxicity. TCR studies are also useful in identifying target species for toxicology studies as well as target organs.
We provide complete and comprehensive TCR studies to support both research efforts and IND-enabling studies for FDA submission in accordance with the FDA’s recommendation.
Research Tissues Applications
- Complete tissue bank of a variety of species including transgenic/knockout models, diseased tissue and tumors; frozen and fixed tissues for human tissue cross-reactivity studies; and in vivo studies
- Comprehensive, high-quality audited reports
- Digital photomicroscopy
- Digital image analysis and histomorphometry
- Quality assurance with critical phase audits
- Rapid scheduling and reporting
- Reasonable cost-effective pricing
- Strong expertise in immunohistochemistry, histology and immunopathology with both animal and human tissues
- Study-specific protocols prepared to reflect your exact requirements
- Tissue evaluation by experienced ACVP board-certified veterinary pathologist
- Tumor bank contains a wide variety of common, rare and unusual human tumors
Our studies are conducted in three phases:
Phase 1: Initial Characterization and Optimization
For the initial characterization and optimization, the optimal specificity and staining conditions for the experimental antibody is determined.
Phase 2: Preliminary Tissue Cross-Reactivity Screening
Using the optimal specificity and staining conditions, a preliminary study with the standard 37 tissues is conducted and evaluated, including:
- Adrenal gland
- Bladder
- Blood cells
- Bone marrow
- Breast
- Cerebellum
- Cerebral cortex
- Colon
- Endothelium
- Eye
- Fallopian tube
- Gastrointestinal tract – colon, esophagus, small intestine, stomach
- Heart
- Kidney
- Liver
- Lung
- Lymph node
- Ovary
- Pancreas
- Parathyroid
- Peripheral nerve
- Pituitary
- Placenta
- Prostate
- Salivary gland
- Skeletal muscle
- Skin
- Spinal cord
- Spleen
- Testes
- Thymus
- Thyroid
- Tonsil
- Ureter
- Uterus
Phase 3: Full Cross-Reactivity Study
Following optimization in Phase 1 and 2, a full cross-reactivity study can be performed in accordance with the FDA’s recommendation.
In these studies:
- Tissues used from three unrelated adults
- Experimental antibody at two dose levels
- Isotype control antibody
- β2 microglobulin on each tissue for staining control
- Evaluation by ACVP board-certified veterinary pathologist
- Staining intensity scored 0-4
- Conducted under GLP conditions with audits of critical phases
- Final report suitable for FDA submission
- Archiving
