Izinsizakalo ze-CDMO zama-plasmids - Ibanga lokuhweba
Amasethingi
| Izinsizakalo ze-CDMO zama-plasmid | ||||
| Izinhlobo | Amasethingi | |||
| Ibanga Lokuhweba | 1 | Ukukhiqizwa kwe-GMP yama-plasmid |
● Ukukhishwa kokukhiqizwa: 10 mg ~ 1 g (ngokuya ngezinguquko ezenziwe ngokwezifiso) ● IVolumu Yesivumo: 3 ~ 30 l (ngokuya ngezinguquko ezenziwe ngokwezifiso) ● Indlela yokuhlanza: ezintathu - indlela yesinyathelo / ezimbili - Indlela Yesinyathelo |
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Izinzuzo
| Izinzuzo zohlelo lwethu lwePlasmid:
• Kuthuthukiswe ngokwanele okuzimele 4 uhlelo lwePlasmid nge-kanamycin - ukumelana nohlobo • Uhlelo olunamandla okusebenza okuqhubekayo • Ukulandelana kwe-Plasmid kuyalandeleka, kuhambisana nezidingo, futhi zisebenza kahle • Isipiliyoni esibanzi entweni ephumelelayo ye-IND ye-IND • Imoto - Amasampula e-T cell okusetshenziswa kwemitholampilo njengamanje akhiqiza futhi ayasebenza • 2 - Ama-5 agoqa ama-tit aphezulu ngemuva kokusebenzisa uhlelo lwethu lwe-plasmid kusuka ekuqhathaniseni amaphrojekthi amaningana |
Izinzuzo zokukhiqiza kwethu i-plasmid: • mahhala ama-antibiotic kuyo yonke inqubo yokwenza • Ukukhiqizwa kwePlasmid kanye nokwakha kwasebhange emihlanganweni yokusebenzela ehlukile • Ukuhlukaniswa okuphelele phakathi kwe-non anrelile nezindawo eziyinyumba • Ukusabalalisa imikhiqizo yokugcina usebenzisa i-iholotor • Izitolo ze-CTD ze-CTD zokupakisha i-Plasmid (ye-Lentiviral Vector), ukunciphisa isikhathi sokulungiselela ukuhanjiswa ngo-3 - Izinyanga ezi-4, ezinama-Inds wemikhiqizo embalwa ezinikezwe imvume yokuqala futhi njengamanje esigabeni sami sokufunda emtholampilo |
Inqubo Yokukhiqiza
Ikhwalithi yokulawula
| Into yokuhlola | Indlela yokuhlola | |
| Ukubonakala | Ukuhlolwa Okubonakalayo | |
| Ukukhonjwa | Ukukhonjwa 1 | Imephu yokuvinjelwa |
| Ukukhonjwa 2 | Ukuhlelwa kabusha kwe-Sanger | |
| Ukuzama | pH | Indlela 0631 ye-CHP 2020 |
| Ubumsulwa | I-Chromatography ephezulu yokusebenza kwe-chromatography (HPLC) | |
| Amaprotheni e-Residial E.Coli Hostin cell | U-ELISA | |
| Insalela e.coli DNA | Q - PCR | |
| Insalela e.coli rna | Q - PCR | |
|
Ama-anti e-antibiotic asele |
U-ELISA | |
| Endotoxin | Indlela 1143 ye-CHP 2020 | |
| Izilima | Indlela 1101 ye-CHP 2020 | |
| Ukuzimisela kokuhlanza | Ukugxila kwe-DNA | Indlela 0401 ye-CHP 2020 |
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.
