CDME Services yeLentivaram Vectors - Iit giredhi / non - clinical chikamu
Masevhisi
| CDME Services yeLentivaram Vectors (Hilenti® Platform) | ||||
| Mhando | Masevhisi | |||
|
Iit giredhi |
1 | Yakazvimirira yakavakirwa ina - Plasmid system |
● Chizvarwa chechitatu China - Plasmid System ● Kanamycin - Kudzivisa Gene ● Hapana patent rezinesi rinodiwa |
● Kubatana kusine chekuita neIndic kutumira |
| 2 | Kugadzira uye kuongororwa kweLentivaram Vectors (GMP - Sa) |
● Kugadziriswa kwekugadzira uye kufungidzira |
● GMP - semusangano ● Vatsotsike uye vanoteedzera zvinyorwa ● GRM - SEZVINOGONESESA MABHUKU MABHUKU |
|
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 |
|
| 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.
