CDME Services yeLentivaram Vectors - Ind giredhi
Masevhisi
| Ind giredhi | 1 | Yakazvimirira yakavakirwa ina - Plasmid system |
● Chizvarwa chechitatu China - Plasmid System ● Kanamycin - Kudzivisa Gene ● Kupa rezinesi, kana zvichidikanwa |
● Kutevera zviyero zvekutumira muChina uye US ● yakazara - GMP musangano ● Yakaparadzaniswa nzvimbo yekugadzira mabhangi emasero ● Kuparadzanisa mashopu mukati mevasiri - nzvimbo dzakashata uye dzakashata ● GPM YEMAHARA Management System |
| 2 | Kusikwa kweGMP Cell Bank |
● Nhamba dzakasarudzika dzemabhangi ezvikwereti kuti riiswe ● Cell Bank Kugadziriswa Kwekudzidza |
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| 3 | Maitiro uye bvunzo nzira yekuvandudza |
● Kutevera zvinodiwa purojekiti (pasi pekuchinja kwakarongeka) |
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| 4 | GMP Kugadzira yeLentivaram Vectors |
● Biororector process: 5 ~ 50 l kurasa bioreactor process (pasi pekushandurwa kwakagadziriswa) ● Kugadzira chiyero: 2 ~ 30 l (pasi pekuchinja kwakagadziriswa) |
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| 5 | Kuyedzwa kwelentivaram velts |
● TECT YEMAHARA ● Chegumi chinotapukira ● Inoshanda Titer ● Kusara 293T host cell Cell kuongororwa ● Kusara 293T host host cell protein kuyedza ● Kusara kwehukuru hweDNA kuyedzwa ● Kusara kweBenzonase kuyedza ● E1A / SV40 ● Kusara nguva yekuedza ● ScAn Salgment Saizi ● Exogenus virokines ● Simba ● Mycoplasma ● Enyikaxin |
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| 6 | Nzira Inoshanda |
● Nhangariro ● Kurudyi ● Chairo ● Nhasi uye huwandu ● Lod |
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| 7 | Kugadzika Kudzidza |
● refu - kugadzikana kwenguva ● Kugadzika kugadzikana ● Kusimbisa kuongororwa |
Zvakanakira
| Zvakanakira kushandisa Platferiform yedu yeSerum - Yemahara Yekumiswa kweCusturity yeLentivaram Vectors:
• yemahara yemhuka - inotorwa zvikamu mukati merimwe nguva • mutsara wakakanda kugadzirwa kweiyo lentivaramal vertec • Uchishandisa mudziyo mumwe chete we50 l kuraswa bioreactor • Cell Bank Chisiko muzvikamu zvakaparadzana • Kugovera zvigadzirwa zvekupedzisira uchishandisa isimbe isimbe • Akazvitsaurira Lentivirus system yeMota - T masero, ane hushoma hwehutachiona hwakanaka • Mari yakaderera mari uye kuyedza mutengo (hapana zvinodiwa zvekuyedza kweBSA uye yakasara pancreattic enzymes) • dzinoverengeka dzakabudirira ind inclismisions kuNMPA yeLentivaram Vegetme mota - T Masero |
Kugadzira maitiro
Mhando yekudzora
| Chigadzirwa | Bvunzo chinhu | Nzira yekuyedza |
| Kukohwa Fluid | Adventitious virus kusvibiswa | Nzira 3302 ye Chp 2020 |
| Kudzokorora - Anokwanisa Lentiviruses | Chiratidzo cell tsika nzira | |
| Zvinodhaka zvinhu / zvakapedza chigadzirwa | Chitarisiko | Kuongorora kwekuona |
| Shuwa | Nzira 1101 yeChp 2020 | |
| Mycoplasma |
Nzira 3301 yeChp 2020 |
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| pH | Nzira 0631 yeChp 2020 | |
| Osmollality | Nzira 0632 of Chp 2020 | |
| Target gene chimiro kuzivikanwa | Kutevedzana | |
| Vakasara host host cell protein | Elisa | |
| TECLECT TET (P24) | Elisa | |
| Inoshanda titer | Kuyerera Cytometry | |
| Endotoxin | Nzira 1143 ye Chp 2020 | |
| Vakasara benzonase | Elisa | |
| Residial host cella | q - PCR | |
| Residhal E1A Gene Kuendesa | CO - Nzira yetsika | |
| ResiDual SV40 Gene Kutamisa | CO - Nzira yetsika |
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.
