Izinsizakalo ze-CDMO ze-Lentiviral Vectors - Ibanga
Amasethingi
| Ibanga | 1 | Ngokuzimela kwakha ezine - uhlelo lwe-plasmid |
● Isizukulwane Esithathu Kune - Uhlelo lwePlasmid ● Kanamycin - ukumelana nohlobo ● Ukunikeza ilayisense, uma kudingeka |
● Amazinga okulandela ukulethwa eChina nathi ● Full - Indawo yokusebenzela ye-GMP ● Indawo ehlukile yokwakha amabhange amaseli ● Okwehlukanisa ama-workshop ngaphakathi kwe-non - izindawo eziyinyumba nezinyumba ● Uhlelo lokuphathwa kwekhwalithi ye-GMP |
| 2 | Indalo ye-GMP Cell Bank |
● Inombolo ehambisanayo yamabhange amaseli okufanele adalwe ● Ucwaningo lwe-Cell Bank Studen |
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| 3 | Inqubo nokuthuthukisa indlela yokuhlola |
● Ngemuva kwezidingo zephrojekthi (ngokuya ngezinguquko ezenziwe ngezifiso) |
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| 4 | Ukukhiqizwa kwe-GMP ye-Lentiviral Vectors |
● Inqubo ye-bioreatActor: 5 ~ 50 l elahlekile ye-bioreactor (ngokuya ngezinguquko ezenziwe ngezifiso) ● Ukukhiqizwa kwesilinganiso: 2 ~ 30 l (ngokuya ngezinguquko ezenziwe ngezifiso) |
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| 5 | Ukuhlolwa kwe-Lentiviral Vectors |
● Ithithi ● Ithimba Lokungena ● Ithimba elisebenzayo ● Insalela engu-293T yokusingathwa kwe-DNA HIV ● Ukuhlolwa kwamaprotheni we-desiual 293t ● Ukuhlolwa kwe-DNA okuseleyo ● Ukuhlolwa kwe-benzonase okusele ● I-E1A / SV40 ● Ukuhlolwa kwe-plasmid okusele ● Usayizi weClogelt ● Ama-virokines ahlukene ● inzalo ● mycoplasma ● Endotoxin |
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| 6 | Ukuqinisekiswa kwendlela |
● Ukucacisa ● Ukunemba ● Ukucacisa ● ulayini nobubanzi ● ILod |
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| 7 | Isifundo Sokuqina |
● Isikhathi eside - ukuqina kwethemu ● Ukuqina okusheshisiwe ● Ukuhlolwa kwengcindezi |
Izinzuzo
| Izinzuzo zokusebenzisa ipulatifomu yethu ye-serum - Ukumiswa kwamahhala kwesiko lesiko le-Lentiviral Vectors:
• mahhala isilwane - izingxenye ezithathwe kuyo yonke inqubo • Ukukhiqizwa ngokuqondile kokukhiqizwa kwe-lentiviral vevers • Usebenzisa isitsha esisodwa se-bioreactor elahlekile engu-50 l • Indalo yasebhange yaseCill kuma-workshops ahlukile • Ukusabalalisa imikhiqizo yokugcina usebenzisa i-Isolator eyinyumba • Uhlelo lwe-lentivirus olunikezelwe lwemoto - amaseli we-T, ngokusebenza kahle kokutheleleka ngokweqile • Izindleko zokukhiqiza eziphansi nezindleko zokuhlola (azikho izidingo zokuhlolelwa ama-BSA nama-enzyme asalayo) • Ukulethwa okuningana kwe-IND ephumelele ku-NMPA ye-Lentiviral Vectors yemoto - amaseli we-T |
Inqubo Yokukhiqiza
Ikhwalithi yokulawula
| Umphumela | Into yokuhlola | Indlela yokuhlola |
| Hlola uketshezi | Ukungcoliswa kwegciwane le-advent | Indlela 3302 ye-CHP 2020 |
| Ukuphindaphinda - Ama-lentiviruses anekhono | Indlela Yesiko Lenkomba | |
| Izidakamizwa / Umkhiqizo Oqedile | Ukubonakala | Ukuhlolwa Okubonakalayo |
| Izilima | Indlela 1101 ye-CHP 2020 | |
| Mycoplasma |
Indlela 3301 ye-CHP 2020 |
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| pH | Indlela 0631 ye-CHP 2020 | |
| OsmoLality | Indlela 0632 ye-CHP 2020 | |
| Ithango lokuhlonza gene | Ukulandelana | |
| Amaprotheni e-Residial Host Cell | U-ELISA | |
| Ithithi (P24) | U-ELISA | |
| I-Functional Titer | Ukugeleza i-cytometry | |
| Endotoxin | Indlela 1143 ye-CHP 2020 | |
| I-Senzonase eyale | U-ELISA | |
| I-Desidial Host Cell DNA | Q - PCR | |
| Ukudluliselwa kwe-gene ye-e1a | Co - indlela yesiko | |
| Ukudluliselwa kwe-SV40 ye-SV40 | Co - indlela yesiko |
I-Project Timeline
Uhlelo Lokulawulwa Kwephrojekthi
I-Hillgene Project Management Team, equkethe ososayensi abayinhloko, abaphathi bephrojekthi, ochwepheshe bephrojekthi ye-QA ne-GMP, bazokwenza imizamo yokuqinisekisa ukusebenza okubushelelezi nokuzwakalayo kwephrojekthi ngayinye ye-GMP.
