Tissue Cross Reactivity Studies are essential studies in the development of monoclonal antibodies and other related biologics and are required by the FDA as part of regulatory submissions for biologics. The purpose of the Tissue Cross Reactivity Study is to assure that the experimental or test antibody does not bind to epitopes other than the target site as this could lead to treatment-related toxicity in human subjects.
- Tissue Cross Reactivity Studies identify epitopes that will bind monoclonal antibodies
- Tissues from humans, primates, and other species available for assessment
- Complete human, primate, and animal frozen tissue bank
- Identification of tissues treated with monoclonal antibodies and tissues that cross react with antibodies
- GLP and NonGLP
- State-of-the-art reports suitable for regulatory submission.