CDME Services yeMota - T Masero - Kiriniki giredhi
Masevhisi
| CDME Services yeMota - T Masero (Hicellx®Chikuva) | ||||
| Mhando | Masevhisi | |||
| Kiriniki giredhi | 1 | GMP Kugadzira Mota - T Masero |
● Kugadzira chiyero: 200 ml ~ 20 l (pasi pekuchinja kwakagadziriswa) ● Dhiza nzira: inochinja-chinja maitiro uye pasi pekuchinja kwakagadziriswa |
● Full - GMP compleanpelant musangano weB + giredhi ine unidirectional mweya kuyerera ● GPM YEMAHARA Management System ● Inosanganisira muzvidzidzo zvekiriniki zvinoenderera mberi |
| 2 | Tekinoroji kuendesa |
● Kuendesa tekinoroji ● Kugamuchira tekinoroji kuendesa |
● Zvakanaka - Yakasimbiswa Chirongwa cheTekinoroji Kuendesa ● Zvakanaka - Yakasimbiswa chirongwa yekugamuchira tekinoroji kuendesa ● Ronga kuendesa tekinoroji akasiyana pamatanho akasiyana |
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Zvakanakira
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Zvakanakira kushandisa yedu Hicellx®Technology Puratifomu: • Uchishandisa yakazvimirira yakagadzirwa cell yeCell Cell gadziriro • Uchishandisa yakavharwa uye otomatiki cell midziyo, yakafanana nemakambani epasi rose epasirese • Mashandiro emusangano anoenderana nekiriniki uye anotengeserana zvinodiwa: mamakisi b + a, Unidirectional Mhepo kuyerera, yakazara - GPM • cell proliferation ine yakakwira chiyero, yakagadzirisa nyaya dzekudzikama dzakaderera huwandu uye huwandu hwekuwedzera • inochinjika yakakodzera yekugadzira uye kuyedzwa kweyakasiyana-siyana cellular kurapa zvigadzirwa • Chiitiko chakawandisa mukushandisa iyo yakavharwa uye otomatiki cell yeMidziyo • Zvakaitika mukugadzira 200+ iit clinical samples • Kuziva mukutumira kweMotokari - T Cell chigadzirwa, iyo yakabudirira kubvumidzwa naNmpa • Zvakaitika mukutsigira tekinoroji kuendesa kiriniki batch yemotokari - tero zvigadzirwa uye mukugadzira sampuli yekushandisa kwekiriniki |
Kugadzira maitiro
Mhando yekudzora
| Mhando | Bvunzo chinhu | Nzira yekuyedza |
| Maitiro ekuedzwa | Chitarisiko | Kuongorora kwekuona |
| pH | Nzira 0631 yeChp 2020 | |
| Osmollality | Nzira 0632 of Chp 2020 | |
| Cellular hunhu / mabasa | Cell Count | Fluorescence Staining |
| Cell viability | Fluorescence Staining | |
| Mota yakanaka | Kuyerera Cytometry | |
| Immpos Celler | Kuyerera Cytometry | |
| Cytokine sevhmonion | Elisa | |
| Cytotoxity | Seper protocol | |
| Kusachena | Yakasara Tsika Yekuwedzera | Zvichienderana nemhando yekuwedzera |
| Reserial Churchic Bead Kuverenga | Microscopy | |
| Kuchengetedzwa | Nhamba yemako emako makopi makopi | q - PCR |
| Endotoxin kuyedzwa | Nzira 1143 ye Chp 2020 | |
| Kutsvedza kwekuedzwa |
Kukurumidza Kuedzwa |
|
| Nzira 1101 yeChp 2020 | ||
| Mycoplasma kuongorora | q - PCR | |
| Nzira 3301 yeChp 2020 | ||
| Rcl | q - PCR |
Purojekiti nguva
Chirongwa cheProjekiti Manage
Hillgene Project Provesment timu, inosanganisira masayendisiti makuru, mamaneja eprojekiti, Project QA uye GPM Nyanzvi, ichaita nhamburiko dzekushanda uye neyakajeka kushanda kwega kwega neGMP.
