CDME Services yeMota - T Masero - Iit giredhi / non - clinical chikamu
Masevhisi
| CDME Services yeMota - T Masero (Hicellx®Technology Platform) | ||||
| Mhando | Masevhisi | |||
| Iit giredhi | 1 | Dossier Kugadzirira |
● Kubvumidzwa Kwetsika ● Hirasi kutenderwa |
● Kubatana kusine chekuita neIndic kutumira ● GMP - semusangano ● Vatsotsike uye vanoteedzera zvinyorwa ● GRM - SEZVINOGONESESA MABHUKU MABHUKU ● Kugadzirwa 200+ Batch |
| 2 | Kuita Kubudirira |
● Kutevera zvinodiwa purojekiti (pasi pekuchinja kwakarongeka) |
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| 3 | Maitiro ekubvumidzwa |
● Kugadzira mabhedhi matatu akateedzana, achisangana neyekutanga dhizaini zvinodiwa uye zvakatemwa |
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| 4 | Kuchengetera Kugadzikana |
● Kutevera zvinodiwa purojekiti (pasi pekuchinja kwakarongeka) |
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| 5 | Kutumira kugadzikana |
● Kutevera zvinodiwa purojekiti (pasi pekuchinja kwakarongeka) |
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| 6 | Sero Kuwana uye Kuedza (GMP - SEZVINOTENDA) |
● Kubatanidza kutumira ● Kugadzira chiyero: 200 ml ~ 20 l (pasi pekuchinja kwakagadziriswa) ● Dhiza nzira: inochinja-chinja maitiro uye pasi pekuchinja kwakagadziriswa |
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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 |
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| Nzira 1101 yeChp 2020 | ||
| Mycoplasma kuongorora | q - PCR | |
| Nzira 3301 yeChp 2020 | ||
| Rcl | q - PCR |
Purojekiti nguva
Hillgene Project Provesment timu, inosanganisira masayendisiti makuru, mamaneja eprojekiti, Project QA uye GPM Nyanzvi, ichaita nhamburiko dzekushanda uye neyakajeka kushanda kwega kwega neGMP.
