FDA Tissue Panels
FDA guidance on the testing of monoclonal antibody or peptide therapeutic products for human use highlights the risk potential when the same or related antigenic determinant as targeted by the therapeutic antibody or peptide is expressed on human cells or tissues other than the intended target tissue.
Cross-reactivity studies with human tissues should be conducted to search for cross-reactions or non-target tissue binding to screen for polymorphisms on:
- A panel of normal, non-diseased Human cells or tissues with quick-frozen adult tissues and
- Tissues from at least three unrelated human donors.
Cambridge Bioscience can provide all 32 of the snap frozen human tissues required to undertake a cross reactivity study of this kind. Samples are ethically sourced and are tested for appropriate morphology in frozen and fixed tissue formats.
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