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![PASSPORT OF CELL SUSPENSION
Sample ID: (_ _._ _._ _/_)(_)(_ _ _)(_ _ _ _ _ _)
Type of testing Marker Result Marker Result
Screening Donors
(ELISA)
HIV 1 [ ] CMV [ ]
HIV 2 [ ] HTLV [ ]
HBV [ ] VDRL [ ]
HCV [ ]
Cell test-control
(PCR)
Pathogen Result Pathogen Result
HBV [ ] HCV [ ]
CMV [ ] EBV [ ]
HSV 1 & 2 [ ] HIV 1 & 2 [ ]
Treponema pallidum [ ] Mycoplasma hominis [ ]
Ureaplasma sp. [ ] Chlamydia (all species) [ ]
Toxoplasma gondii [ ] X-Y chromosome detection [ ]
Microbiology control
Sterility testing
Pathogen Result Pathogen Result
Aerobic m/o [ ] Fungus [ ]
Anaerobic m/o [ ]](https://image.slidesharecdn.com/cryobank-151121144916-lva1-app6891/85/Sunil-Saldanha-14-320.jpg)
![PASSPORT OF CELL SUSPENSION
Gestation period of the
human fetus
(mark as [√])
Weeks Result Weeks Result Weeks Result
6-7 weeks [ ] 13 weeks [ ] 17 weeks [ ]
8-9 weeks [ ] 14 weeks [ ] 18 weeks [ ]
10-11 weeks [ ] 15 weeks [ ] 19 weeks [ ]
12 weeks [ ] 16 weeks [ ] 20 weeks [ ]
Cell type
(mark as [√])
Hematopoietic fetal liver stem cells [ ]
Fetal liver hepatoblasts and hepatocytes [ ]
Neural progenitor fetal brain cells [ ]
Quantity & Quality Total Cell Amount per 1 ml
Vible-Cell Amount per 1 ml
Amount of CFU per 1 ml
Amount of mononuclear cells
Karyotyping (FISH)
Transplantation unit: amount of CFU/amount of viable cells
Cryo-protector (mark as
[√])
DMSO [ ]
PVG [ ]
Any other (Name)](https://image.slidesharecdn.com/cryobank-151121144916-lva1-app6891/85/Sunil-Saldanha-15-320.jpg)
![PASSPORT OF CELL SUSPENSION
Phenotype of fetal liver hematopoietic stem cells
HLA typing (Type)
CD Marker
(mark as [√])
CD Marker Result CD Marker Result CD Marker Result
CD4 [ ] CD56 [ ] CD133 [ ]
CD8 [ ] CD62E [ ] CD135 [ ]
CD12w [ ] CD62P [ ] CD141 [ ]
CD19 [ ] CD69 [ ] CD144 [ ]
CD24 [ ] CD74 [ ] CD158 [ ]
CD27 [ ] CD83 [ ] CD163 [ ]
CD31 [ ] CD90 [ ] CD184 [ ]
CD34 [ ] CD100 [ ] CD202a [ ]
CD42 [ ] CD105 [ ] CD326 [ ]
CD45 [ ] CD117 [ ] CD133 [ ]
Marker Phenotype of fetal liver hepatoblasts and hepatocytes
Result Marker Result Marker Result
AFP [ ] HLA-A [ ] CD74 [ ]
CD326 [ ] HLA-B [ ] CD135 [ ]
Albumin [ ] HLA-DR [ ] CD326 [ ]
C017-1A antigen [ ] CD68 [ ]](https://image.slidesharecdn.com/cryobank-151121144916-lva1-app6891/85/Sunil-Saldanha-16-320.jpg)
![PASSPORT OF CELL SUSPENSION
Phenotype of neural fetal brain progenitor cells
Marker Result Marker Result Marker Result
Nestin [ ] HLA-A [ ] CD133 [ ]
β-tubulin III [ ] HLA-B [ ] CD271 [ ]
Vimentin [ ] HLA-DR [ ] CD304 [ ]
GFAP [ ] CD24 [ ] CD326 [ ]
NCAM [ ] CD25 [ ] CD69 [ ]
GalC [ ] CD74 [ ]
Genetic abnormality in cells if any detected by karyotyping:
Please enlist _____________________________________________________________________
_______________________________________________________________________________
_________________________________________________________________________________________________________________
_____________________________________________](https://image.slidesharecdn.com/cryobank-151121144916-lva1-app6891/85/Sunil-Saldanha-17-320.jpg)
Sunil Saldanha
1. The document describes the facilities and procedures of Cryobank at EmProCell Clinical Research Pvt. Ltd. in Mumbai for processing and storing fetal tissue extracts and organ-specific progenitor cells. 2. EmProCell has laboratories for biotechnology, biosafety, research and development, sample processing, manufacturing, cryobanking, ELISA testing, cell culture, pathogen detection, karyotyping and hybridization, and sterilization. 3. Donor screening involves ELISA testing of pregnant women's blood for HBV, HCV, CMV, HTLV, and VDRL. Samples then undergo pathogen detection by PCR and sterility testing before being processed and cryop
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Sunil Saldanha
- 1. CRYOBANK EMPROCELL CLINICAL RESEARCHPVT. LTD., MUMBAI
- 2. FETAL TISSUE EXTRACT 834 490 287 422 150 827 377 409 82 431 523× 10 104 × 10 442 71 231 138 30 36 162 12 261 225 439 266 36 62 448 171 127 Amount (vials - 1.8 ml): 14444 vials ~ 26 l
- 3. FETAL ORGANSPECIFIC PROGENITORCELLS 337 × 10 423 × 10 262 702 204 466 720 335 187 178 523 104 442 41 77 6 61 24 135 49 12 64 47 17 Amount (vials - 1.8 ml): 11276 vials ~ 20 l
- 4. EmProCell Laboratory Structure EmProCell BiotechnologyLab Bio-Safety Lab R&D Lab Sample Processing Manufacturing Cryobank ELISA Cell Culture Pathogen Detection Karyotyping & Hybridization Sterilization lab Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 5. Donor Screening Bio-Safety Dept-EmProCell Clinical Research Pvt. Ltd 14/10/2012 Pregnant women blood ELISA test for: HBV HCV CMV HTLV VDRL
- 6. Chromogenic End-Point Assay (QCL1000, Lonza). Kit Sensitivity: 0.01 EU/ml ELISA Lab Endotoxin Detection Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 7. Pathogen Detection Lab Standardkits used for : • DNA Isolation • RNA Isolation Nucleic Acid Isolation Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd 14/10/2012
- 8. HBV HCV CMV EBV HSV1 &2 HIV 1& 2 Treponema pallidum Mycoplasma hominis Ureaplasma sp. Chlamydia all species Toxoplasma gondii Pathogen Detected Pathogen Detection Lab Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd.
- 9. Pathogen detection Lab Bio-SafetyDept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 10. Cell Culture lab Bio-SafetyDept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 11. Sterility testing ofsamples Outsourced to : Super Religare Laboratories Test performed : Culturing of Aerobic bacteria Anaerobic bacteria Yeast/ molds Method Used : Chemi-luminoscent Assay Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 12. Sterility testing ofsamples at EmProCell Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 13. Karyotyping Lab Traditional karyotyping Tocheck on any genetic abnormalities in samples Only Sample with normal karyotype selected Bio-Safety Dept- EmProCell Clinical Research Pvt. Ltd. 14/10/2012
- 14. PASSPORT OF CELLSUSPENSION Sample ID: (_ _._ _._ _/_)(_)(_ _ _)(_ _ _ _ _ _) Type of testing Marker Result Marker Result Screening Donors (ELISA) HIV 1 [ ] CMV [ ] HIV 2 [ ] HTLV [ ] HBV [ ] VDRL [ ] HCV [ ] Cell test-control (PCR) Pathogen Result Pathogen Result HBV [ ] HCV [ ] CMV [ ] EBV [ ] HSV 1 & 2 [ ] HIV 1 & 2 [ ] Treponema pallidum [ ] Mycoplasma hominis [ ] Ureaplasma sp. [ ] Chlamydia (all species) [ ] Toxoplasma gondii [ ] X-Y chromosome detection [ ] Microbiology control Sterility testing Pathogen Result Pathogen Result Aerobic m/o [ ] Fungus [ ] Anaerobic m/o [ ]
- 15. PASSPORT OF CELLSUSPENSION Gestation period of the human fetus (mark as [√]) Weeks Result Weeks Result Weeks Result 6-7 weeks [ ] 13 weeks [ ] 17 weeks [ ] 8-9 weeks [ ] 14 weeks [ ] 18 weeks [ ] 10-11 weeks [ ] 15 weeks [ ] 19 weeks [ ] 12 weeks [ ] 16 weeks [ ] 20 weeks [ ] Cell type (mark as [√]) Hematopoietic fetal liver stem cells [ ] Fetal liver hepatoblasts and hepatocytes [ ] Neural progenitor fetal brain cells [ ] Quantity & Quality Total Cell Amount per 1 ml Vible-Cell Amount per 1 ml Amount of CFU per 1 ml Amount of mononuclear cells Karyotyping (FISH) Transplantation unit: amount of CFU/amount of viable cells Cryo-protector (mark as [√]) DMSO [ ] PVG [ ] Any other (Name)
- 16. PASSPORT OF CELLSUSPENSION Phenotype of fetal liver hematopoietic stem cells HLA typing (Type) CD Marker (mark as [√]) CD Marker Result CD Marker Result CD Marker Result CD4 [ ] CD56 [ ] CD133 [ ] CD8 [ ] CD62E [ ] CD135 [ ] CD12w [ ] CD62P [ ] CD141 [ ] CD19 [ ] CD69 [ ] CD144 [ ] CD24 [ ] CD74 [ ] CD158 [ ] CD27 [ ] CD83 [ ] CD163 [ ] CD31 [ ] CD90 [ ] CD184 [ ] CD34 [ ] CD100 [ ] CD202a [ ] CD42 [ ] CD105 [ ] CD326 [ ] CD45 [ ] CD117 [ ] CD133 [ ] Marker Phenotype of fetal liver hepatoblasts and hepatocytes Result Marker Result Marker Result AFP [ ] HLA-A [ ] CD74 [ ] CD326 [ ] HLA-B [ ] CD135 [ ] Albumin [ ] HLA-DR [ ] CD326 [ ] C017-1A antigen [ ] CD68 [ ]
- 17. PASSPORT OF CELLSUSPENSION Phenotype of neural fetal brain progenitor cells Marker Result Marker Result Marker Result Nestin [ ] HLA-A [ ] CD133 [ ] β-tubulin III [ ] HLA-B [ ] CD271 [ ] Vimentin [ ] HLA-DR [ ] CD304 [ ] GFAP [ ] CD24 [ ] CD326 [ ] NCAM [ ] CD25 [ ] CD69 [ ] GalC [ ] CD74 [ ] Genetic abnormality in cells if any detected by karyotyping: Please enlist _____________________________________________________________________ _______________________________________________________________________________ _________________________________________________________________________________________________________________ _____________________________________________
- 18. THANK YOU Bio-Safety Dept-EmProCell Clinical Research Pvt. Ltd. 14/10/2012