Copyright
©The Author(s) 2015.
World J Med Genet. Feb 27, 2015; 5(1): 1-13
Published online Feb 27, 2015. doi: 10.5496/wjmg.v5.i1.1
Published online Feb 27, 2015. doi: 10.5496/wjmg.v5.i1.1
Table 4 TG-C release test
| Test | Method | Specification |
| Release tests and specifications for hChonJ cell | ||
| Identification | ||
| Cell growth and morphology | Visual (test code 30117) | Fibroblast-like: spindle shaped/bipolar or multipolar cells |
| Viability | Trypan blue dye exclusion | > 70% |
| (test code 30458) | ||
| Mycoplasma | 1993 Points to consider (test code 30055) | Negative |
| RAP test | In vivo and ELISA (test code 30163) | Negative |
| Sterility (direct inoculation method) | 21 CFR 610.12 (test code 30744) | Negative |
| Endotoxin | LAL (test code 37653) | < 5 EU/mL |
| Release tests and specifications for hChonJb#7 Cell | ||
| Identity | Epithelial-like: fried egg or polygonal-shaped appearance | |
| Cell growth and morphology | Visual (test code 30117) | |
| Type II collagen assay | RT-PCR (test code 30412) | Type II collagen present |
| TGF-β1 presence | PCR (test code 30959) | TGF-β1 present |
| Potency (TGF-β1 assay) | ELISA (test code 30444) | 1-50 ng/105 cells/24 h |
| Viability | Trypan blue dye exclusion (test code 30458) | > 70% |
| RCR | Co-culture of end of production cells (test codes 30628) | Negative |
| Supernatant amplification (test code 30633) | Negative | |
| Mycoplasma | 1993 points to consider (test code 30055) | Negative |
| Rat antibody production | In vivo and ELISA (test code 30163) | Negative |
| Endotoxin | LAL (test code 37653) | < 5 EU/mL |
| Sterility | 21 CFR 610.12 (test code 30744) | Negative |
- Citation: Noh MJ, Copeland O, O’Mara M, Lee KH. Cell mediated gene therapy: A guide for doctors in the clinic. World J Med Genet 2015; 5(1): 1-13
- URL: https://www.wjgnet.com/2220-3184/full/v5/i1/1.htm
- DOI: https://dx.doi.org/10.5496/wjmg.v5.i1.1