CDME Services yeLentivaram Vectors - Kiriniki giredhi
Masevhisi
| CDME Services yeLentivaram Vectors (Hilenti®Chikuva) | ||||
| Mhando | Masevhisi | |||
| Kiriniki giredhi | 1 | GMP Kugadzira yeLentivaram Vectors |
● Biororector process: 5 ~ 50 l kurasa bioreactor process (pasi pekushandurwa kwakagadziriswa) ● Kugadzira chiyero: 2 ~ 30 l (pasi pekuchinja kwakagadziriswa) |
● yakazara - GMP musangano ● Kuparadzanisa mashopu mukati mevasiri - nzvimbo dzakashata uye dzakashata ● GPM YEMAHARA Management System ● Kudyara kwakasimbiswa, nzvimbo nemidziyo inoenderana nezvinodiwa nekiriniki |
| 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 |
|
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.
