Izinsizakalo ze-CDMO ze-Lentiviral Vectors - I-IIT grade / non - isigaba somtholampilo
Amasethingi
| Izinsizakalo ze-CDMO zama-Lentiviral Vectors (HELENDI® Platform) | ||||
| Izinhlobo | Amasethingi | |||
|
Ibanga |
1 | Ngokuzimela kwakha ezine - uhlelo lwe-plasmid |
● Isizukulwane Esithathu Kune - Uhlelo lwePlasmid ● Kanamycin - ukumelana nohlobo ● Ayikho ilayisense elidingekayo lobunikazi |
● Ukuxhumeka komthungo kokulethwa kwe-IND |
| 2 | Ukukhiqiza nokuhlola kwama-veector we-lentiviral (GMP - Like) |
● Ukukhishwa okukhiqizwayo okuhambisana nokucaciswa |
● I-GMP - Njenge-workshop ● Imibhalo eyiqiniso nethosiwe ● I-GMP - njengohlelo lokuphathwa kwekhwalithi |
|
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 |
|
| 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.
