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品質管理
組織再生に入る以前の生物学的安全性菅理
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以下のものの不在の確認：
| - 1型、2型HIV （ヒト免疫不全ウイルス）、B型、C型肝炎ウイルス、サイトメガロウイルス
- 梅毒
- 細菌
- 真菌
- マイコプラスマ
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技術データシート
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| | RHE
再生ヒト表皮 | HCE
再生ヒト角膜上皮 | | 説明 | スキネティック RHE/S/17
0.5 cm² の正常ヒトケラチノサイトからなる再生表皮。細胞は、化学的構成成分の明らかなケミカリー・ディファインド培地を用い、不活性ポリカーボネート・フィルター上、空気－液体界面にて17日間培養されます。 | スキネティック RHC/S/5
0.5 cm² の再生上皮。トランスホームしたヒト角膜上皮細胞をケミカリー・ディファインド培地を用い、不活性ポリカーボネート・フィルター上、空気－液体界面にて5日間培養して再生します。 | | 適用 | 科学的用途に限る－ヒト由来製品 | 科学的用途に限る－ヒト由来製品 | | 保存 | この製品は、無菌的に、準備、梱包されています。 | この製品は、無菌的に、準備、梱包されています。 | 継代数
または
バッチ番号 | 第二継代 (細胞株 n° PK2 HRS 18 ) | 07 022D 0907 | | 由来 | 包皮、年齢：4歳 | 遺伝子組み換えされた不朽化ヒト角膜上皮細胞 (HCE) | | 組織学 | | | | 品質管理 | 第7日目、同時進行の液面下培養:
詳細：細胞増殖と無菌性
第17日目、組織学
(HE染色、パラフィン垂直切片)
詳細：基底細胞層, 有棘細胞層, 顆粒細胞層と角質層から成る良く分化した表皮。少なくとも4層の細胞層が存在。
第17日目、細胞生存性（MTT試験 n= 2):
特性：OD> 0.7
結果 : OD = 1.338 ± 0.064 | 第5日目、同時進行の液面下培養:
詳細：細胞増殖と無菌性
第5日目、組織学
(HE染色、パラフィン垂直切片)
詳細：少なくとも4層の細胞層が存在。
第5日目、細胞生存性（MTT試験 n= 2):
特性：OD> 0.7
結果: OD = 1.085 ± 0.054 | | 生物学的安全性 | 同株細胞の細胞ペレットを用いて、以下の事項を確認：
PCR (Amplicor)法によるHIV組込みプロウイルスDNAの不在
PCR (Amplicor)法によるC型肝炎ウイルスDNAの不在
培養の上澄み液を用いて、以下の事項を確認：
B型肝炎HBs抗原の不在
細菌と真菌の不在
マイコプラスマの不在 | 同株細胞の細胞ペレットを用いて、以下の事項を確認：
PCR (Amplicor)法によるHIV組込みプロウイルスDNAの不在
PCR (Amplicor)法によるC型肝炎ウイルスDNAの不在
培養の上澄み液を用いて、以下の事項を確認：
B型肝炎HBs抗原の不在
細菌と真菌の不在
マイコプラスマの不在 |
New technical data sheets (update)
| | Reconstructed Human Epidermis (RHE) | | 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. | | Usage | FOR SCIENTIFIC USE ONLY - PRODUCT OF HUMAN ORIGIN | | Storage | This product was prepared and packaged using aseptic techniques.
Store in an incubator at 37° C, 5% CO2 with saturated humidity. | | Passage | Second (strain n° PK2 KRS17)
| | Batch number | 11 022A 0604 | | Origin | foreskin: 3 years | | Histology | | | Quality controls | Test | Acceptance criteria | Result | | Immersed parallel culture at 5 days: | cell growth and sterility | Conform | Histological observation
at day17
(HES stained vertical paraffin
sections) | Well differenciated epidermis consisting of basal, spinous, granular layers and a stratum corneum. At least 4 viable cell layers are present.
Absence of significative histological abnormalities. | Conform
Indicative value :
6 cell layers | Cell viability at day17
(MTT test, n= 2) | O.D. > 0.7
| O.D. = 1,399± 0,054
| | Biological safety | On blood of the same donor, we have verified :
. Absence of HIV-1 and HIV-2
. Absence of hepatitis C
. Absence of hepatitis B
On epidermal cell supernatant of the same donor, we have verified :
. Absence of mycoplasma | | Expiration date | July 4, 2011 : day 24 of airlifted culture |
Lyon, June 27, 2011
Certified and released by Benoît Dewilde
Data validation Anne-Sophie Rigaudeau
Manufactured in accordance to the ISO9001 quality system of Skinethic. |
| | Episkin Small Model | | Description | 0.38 cm² reconstructed epidermis of normal human keratinocytes.
Cells are grown on a collagen matrix, for 13 days. | | Usage | FOR SCIENTIFIC USE ONLY - PRODUCT OF HUMAN ORIGIN | | Storage | This product was prepared and packaged using aseptic techniques.
Store in an incubator at 37° C, 5% CO2 with saturated humidity. | | Passage | Second (Strains n° : 01-KERA-007, 01-KERA-013, 02-KERAMR-005, 08-KERA-003) | | Batch number | 11-EKIN-026 | | Origin | Adult donors | | Histology | | | Quality controls | Test | Specification | Result | Histologyscoring
(HES stained vertical paraffin sections, n = 6) | ≥ 19.5 | 22.0 ± 0.0 (CV = 0.0 %) | | Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum | IC 50 determination
(SDS concentration,
MTT test, n = 14) | ≥ 1.5 mg/ml | 2.3 mg/ml | Statistical Analysis :
→ Histology : probability 0.95 that 100 % of the batch > 20
→ IC 50 : probability 0.95 that IC 50 ≥ 2.2 mg/ml (threshold value) | | Biological safety | On blood of the same donors, we have verified:
. the absence of HIV1 and 2 antibodies (Architect Abbott)
. the absence of hepatitis C antibodies (Architect Abbott)
. the absence of hepatitis B antigen HBs (Architect Abbott)
On epidermal cells of the same donors, we have verified:
. the absence of bacteria, fungus and mycoplasma | | Expiration date | July 4, 2011 |
Lyon, June 28, 2011.
Certified and released by Isabelle GOULET, Quality Control Manager
Manufactured in accordance to the ISO9001 quality system of Episkin. |
| | Human Corneal Epithelium (HCE) | | Description | 0.33 or 0.5 cm² epithelium reconstituted by airlifted culture of transformed human corneal keratinocytes for 5 days in chemically defined medium on inert polycarbonate filters. | | Usage | FOR SCIENTIFIC USE ONLY - PRODUCT OF HUMAN ORIGIN | | Storage | This product was prepared and packaged using aseptic techniques.
Store in an incubator at 37° C, 5% CO2 with saturated humidity. | | Batch number | 11-HCE-030 | | Origin | Immortalized Human Corneal Epithelium cells (HCE) | | Histology | | | Quality controls | Test | Specification | Result | Histology at day 5
(HES stained vertical paraffin sections, n = 9) | Number of cell layers ≥ 4
Absence of significant histological abnormalities | 6
Absence of significant histological abnormalities | Cell viability at day 5
(570 nm optical density,
MTT test, n = 6) | O.D ≥ 0.7 | O.D = 1.0
(CV = 12.1 %) | | Handling: | Human Corneal Epithelium is reconstructed using transformed human cells of Class 2. Its handling requires the user to conform with local regulations applicable to transformed human cells - Class 2. | | Biological safety | On this cell strain, we have verified :
. the absence of HIV integrated pro-viral DNA, by PCR (Amplicor)
. the absence of hepatitis C viral RNA, by rt-PCR (Amplicor)
. the absence of hepatitis B viral DNA, by PCR
. the absence of viral contamination of the virus used for the cell line immortalization
On culture supernatant, we have verified :
. the absence of mycoplasma | | Expiration date | June 13, 2011. |
Lyon, June 6, 2011.
Certified and released by Isabelle GOULET, Quality Control Manager
Manufactured in accordance to the ISO9001 quality system of Episkin. |
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