Tissue Cross-Reactivity Studies
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Normal tissue analysis
Following the development of an immunostaining protocol, options for normal tissue analyses include the following:
Limited analyses of a few (29) selected frozen tissues (non-GLP):
- Cerebellum
- Cerebrum
- Pituitary, anterior lobe
- Eye, retina
- Uterus cervix, stroma with endothelium
- Small intestine, mucosa
- Stomach, mucosa
- Colon, stroma with endothelium
- Blood vessel
- Pancreas
- Adrenal gland
- Parathyroid
- Placenta
- Thymus
- Fallopian tube, mucosa
- Uterus, endocervix
- Ovary
- Thyroid
- Testis
- Liver
- Prostate
- Kidney, cortex
- Heart, muscle
- Skeletal muscle
- Uterus, myometrium
- Colon muscle
- Spleen
- Lymph node
- Skin
32 FDA required normal tissues under non-GLP conditions (1-3 donors)
32 FDA required normal tissues from 3 donors under GLP conditions (formal cross reactivity study on large sections)
Tissue panel includes all samples according to relevant guidelines (FDA/CBER points to consider in the Manufacture and testing of Monoclonal Antibodies, 1997. CPMP Guideline 75/318/EEC Production and Quality Control of Monoclonal Antibodies).
| Adrenal | Lung | Spinal Cord |
|---|---|---|
| Blood Cells | Lymph Node | Spleen |
| Blood vessels (endothelium) | Ovary | Striated (skeletal) Muscle |
| Bone Marrow | Fallopian Tube (oviduct) | Testis |
| Brain - cerebrum (cortex) | Pancreas | Thymus |
| Brain - cerebellum | Parathyroid | Thyroid |
| Breast (mammary gland) | Peripheral Nerve | Tonsil |
| Eye | Pituitary | Ureter |
| Gastrointestinal Tract | Placenta | Urinary Bladder |
| Heart | Prostate | Uterus- body (endometrium) |
| Kidney (glomerulus, tubule) | Salivary Gland | Uterus - cervix |
| Liver | Skin | |
|
1 Blood cells include granulocytes, lymphocytes, monocytes and platelets. 2 Gastrointestinal Tract includes the colon (large intestine), esophagus, small intestine, and stomach. |
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