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Quality controls
Biological safety controls before tissue engineering
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Absence of:
| - viruses HIV 1 & 2, hepatitis B & C, cytomegalovirus
- siphylis
- bacteria
- fungi
- mycoplasma
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| | RHE | HCE | | Description | SkinEthic RHE/S/17
0.5 cm² reconstructed epidermis of normal human keratinocytes. Cells are grown on inert polycarbonate filter on chemically defined medium,
airlifted for 17 days. | SkinEthic RHC/S/5
0.5 cm² epithelium reconstituted by airlifted culture of transformed human keratinocytes for 5 days in chemically defined medium on inert polycarbonate filters. | | Usage | FOR SCIENTIFIC USE ONLY - PRODUCT OF HUMAN ORIGIN | FOR SCIENTIFIC USE ONLY - PRODUCT OF HUMAN ORIGIN | | Storage | This product was prepared and packaged using aseptic techniques. | This product was prepared and packaged using aseptic techniques. | | Passage or batch number | Second (strain n° PK2 HRS 18 ) | 07 022D 0907 | | Origin | Foreskin . Age: 4 years. | Immortalized Human Corneal Epithelial cells (HCE) genetically modified. | | Histology | | | | Quality controls | Immersed parallel culture at 7 days:
Specification: cell growth and sterility.
Histology at day 17 (HE stained vertical paraffin sections)
Specification: Well differenciated epidermis consisting of basal, spinous, granular layers and a stratum corneum.
At least 4 viable cell layers are present.
Cell viability at day 17 (MTT test, n= 2):
Specification : OD> 0.7
Result : OD = 1.338 ± 0.064 | Immersed parallel culture at 5 days:
Specification: cell growth and sterility.
Histology at day 5 (HE stained vertical paraffin sections)
Specification: At least 4 viable cell layers are present.
Cell viability at day 5 (MTT test, n= 2):
Specification : OD> 0.7
Result : OD = 1.085 ± 0.054 | | Biological safety | On a cell-pellet of the same cell strain, we have verified:
. the absence of HIV integrated pro-viral DNA, by PCR (Amplicor)
. the absence of hepatitis C viral DNA, by PCR (Amplicor)
On culture supernatant, we have verified:
. the absence of hepatitis B antigen HBs
. the absence of bacteria and fungus
. the absence of mycoplasma | On a cell-pellet of the same cell strain, we have verified:
. the absence of HIV integrated pro-viral DNA, by PCR (Amplicor)
. the absence of hepatitis C viral DNA, by PCR (Amplicor)
On culture supernatant, we have verified:
. the absence of hepatitis B antigen HBs
. the absence of bacteria and fungus
. the absence of mycoplasma |
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