IiNkonzo ze-CDM zeVenkile yeVenkile - Inqanaba leklinikhi
Iinkonzo
| IiNkonzo zeCDM yeXesha leLentivirial (Hilenti®Iqonga) | ||||
| Iintlobo | Iinkonzo | |||
| Inqanaba leklinikhi | 1 | Ukuveliswa kwe-GMP yeVenkile ye-Lentiviral |
● Inkqubo ye-bioreactor: 5 ~ 50 L I-Bioreactoct inkqubo ye-bioreactoct (phantsi kotshintsho olufanelekileyo) ● Imveliso yemveliso: 2 ~ 30 L (phantsi kotshintsho olufanelekileyo) |
● Izele yindawo yokusebenzela ● Iworkshop ezahluliweyo ngaphakathi kwezi - ezinobungozi kunye nezingaphantsi ● Inkqubo yolawulo lwe-GP ● Isityalo esiqinisekisiweyo, indawo kunye nezixhobo ezihambelana neemfuno zeklinikhi |
| 2 | Ukudluliselwa kwetekhnoloji |
● Ukudluliselwa kwetekhnoloji ● Ukufumana ukuhanjiswa kwetekhnoloji |
● Well - Isicwangciso esisekwe kwiTekhnoloji yeTekhnoloji ● Well - Isicwangciso esisekelweyo sokufumana itekhnoloji yokudluliselwa kwetekhnoloji ● Cwangcisa ukuhambisa itekhnoloji eyahlukileyo kwiinqanaba ezahlukeneyo |
|
Izibonelelo
| Izibonelelo zokusebenzisa iqonga lethu le-serum - Ukunqunyanyiswa okukhulu kokunqunyanyiswa okukhulu kwe-lentiviniphoral verivic:
Mahala isilwanyana - Amacandelo afunyenwe kuyo yonke inkqubo • I-intanethi ikhutshiwe kwimveliso ye-lentivivilral Sebenzisa isikhongozelo esinye se-bioreactoct ye-50 • Ukudalwa kwebhanki yeselfowuni kwiindibano zocweyo ezahlukeneyo • Ukusasaza iimveliso zokugqibela usebenzisa i-Sterle Inkqubo ye-Lentevirus ezinikezelweyo yemoto - Iiseli ze-T, ngokusebenza okuphezulu Iindleko zemveliso ephantsi kunye neendleko zovavanyo (akukho zifuno zokuvavanywa kwe-BSA kunye ne-enzymes ye-pancreatic ye-pancreatic) • Iqela elinempumelelo le-Indlions kwi-NMPA yeVenkile yeVenkile yeZithuthi - T Iiseli |
Inkqubo yokwenziwa kwemveliso
Ulawulo lwemeko
| Imveliso | Into yovavanyo | Indlela yovavanyo |
| Ukuvuna i-fluid | Ungcoliseko lwentsholongwane | Indlela yama-3302 ye-CHP 2020 |
| Ukuphindaphinda - I-lentiviricur | Isalathiso seNkcubeko | |
| Izinto zeziyobisi / kwimveliso egqityiweyo | Imbonakalo | Uvavanyo olubonakalayo |
| Ukuncwina | Indlela i-1101 ye-chp 2020 | |
| I-Mycoplasma |
Indlela yama-3301 ye-CHP 2020 |
|
| pH | Indlela 0631 ye-CHP 2020 | |
| I-Osmolality | Indlela 0632 ye-CHP 2020 | |
| Ithagethi ye-Geege Geene | Ukulandelelana | |
| I-Super I-HOSEIT yeselfowuni | Elisa | |
| Isishumi (P24) | Elisa | |
| Ishumi | Hamba i-cytometry | |
| Endotoxin | Indlela ye-1143 ye-CHP 2020 | |
| I-Personase | Elisa | |
| I-DNA ye-Shursine ye-DNA | Q - I-PCR | |
| I-Sport I-E1A Speene Geene | I-CO - indlela yenkcubeko | |
| I-SV40 i-SV40 i-gener | I-CO - indlela yenkcubeko |
Ixesha leprojekthi
Isicwangciso soLawulo lweProjekthi
Iqela leProjekthi yase-Rillgene, equka izazinzulu zeprojekthi, abaphathi beeprojekthi, iingcali zeProjekthi zePREP, ziya kwenza imizamo yokuqinisekisa ukusebenza kakuhle nokuvakalayo kweprojekthi nganye ye-GMP.
