FDA policy

In 1997, the Center for Biologics Evaluation and Research (a division of the Food and Drug Administration and the Department of Health and Human Services) published recommendations for the approval of monoclonal antibody products for medical use. Non-target specific binding to human tissue may have serious consequences when pharmacologically active antibodies (Ab) are used for treatment of disease. Thus, cross-reactivity studies of therapeutic Ab candidates are conducted prior to Phase I clinical trials to search for cross-reactivity or non-target tissue binding.

Testing for Cross-Reactivity

Antibody cross-reactivity is tested immunohistochemically using a set of snap-frozen normal adult human tissues. High-quality post-mortem specimens (3 - 12 hours post-mortem interval) are available from Cureline for these studies (table below). Some other tissue types can obtained per customer request

Specimen Format and Sets
Normal Human Tumor Tissues Human Brain Map
Normal Human Tissues

To inquire about the current availability of normal specimens in our human tissue bank or to investigate your request feasibility, contact our office or send us an inquiry via email.

Standard Specimen Format and Sets
  • Snap-frozen tissues (1 x 1 cm)
  • OCT-embedded tissues
  • FFPE blocks
  • Normal Human Tumor Tissues Human Brain Regions Set
  • Normal Human Tissue Set
Normal Human Tumor Tissues Human Brain Map
  • Nucleus Substantia nigra
  • Nucleus Raphe
  • Ventral pole
  • Orbital gyrus
  • Cingulum bundle
  • Accumbens
  • Amygdala
  • Putamen
  • Nucleus caudate
  • Hippocampus
  • Thalamus
  • Parietal cortex
  • Cerebellar vermis
  • Cerebellar hemisphere
  • Dorsolateral prefrontal cortex
  • Pituitary gland
  • Hypothalamus
  • Spinal cord (cross-section)
  • Peripheral Ganglia
Normal Human Tissues Panel
  • Endocrine system -Pituitary (Category II)
  • Endocrine system-Adrenal (Category II)
  • Endocrine system -Thyroid (Category II)
  • Endocrine system -Parathyroid
  • Peripheral Blood cells (blood smear slides)
  • Bone marrow
  • CVS-Endothelium (artery, vein)
  • CVS-Heart (myocardium)
  • CVS -Lymph node (central)
  • Spleen
  • CNS -Cerebellum (Category II)
  • CNS- Cerebral cortex (Category II)
  • PNS- Spinal cord (cross-sections)
  • Upper GI tract (Esophagus, stomach)
  • Lower GI tract –Intestines( Duodenum, Ileum, Cecum, Colon, Rectum)
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  • Pancreas (Category II)
  • Liver
  • Urinary tract –Kidney
  • Urinary tract - Ureter
  • Urinary tract – Bladder
  • Respiratory tract- Lung
  • Female reproductive organs-Ovary
  • Female reproductive organs-Fallopian tube
  • Female reproductive organs -Uterus
  • Breast
  • Placenta (different donor)
  • Male reproductive organs -Testis
  • Male reproductive organs-Prostate
  • Skin
  • Adipose tissue( Fat)
  • Striated and Smooth muscle