Izinsizakalo ze-CDMO zama-plasmid - I-IIT grade / non - isigaba somtholampilo

Ukukhiqiza ama-plasmids, isinyathelo esibucayi semoto yokukhiqiza - T yemikhiqizo yeselula yeselula, kubandakanya uchungechunge lwezinqubo eziyinkimbinkimbi zokukhiqiza, ukuhlanzwa, kanye nokuhlaziywa. Njengamathuluzi abalulekile wobunjiniyela bezakhi zofuzo, ama-plasmid angama-bacterial awakwazi ukusetshenziswa kuphela njengemikhiqizo yokugcina yokwakheka kohlobo lwezofuzo kanye nokwelashwa kwamaselula, kodwa futhi njengemikhiqizo ephakathi yokwenziwa kwemikhiqizo yokwenziwa kwamaselula, futhi isetshenziswa ngokungenakuphikwa imikhiqizo yokwelashwa kwamaselula. Ngokuvela komkhakha wezokwelapha amaselula, izimfuno zemakethe zama-plasmid nazo ziyanda ngonyaka ngamunye odlulayo. IHillgene ikhethekile ekuhlinzekweni kwezixazululo ezihlanganisiwe ze-CDMO zemikhiqizo yokwelapha amaselula, isungule ipulatifomu yokukhiqiza ye-GMP yemikhiqizo ye-nucleic acid, ngakho-ke, inganikeza izinsizakalo eziphezulu ze-CDMO zamakhasimende anezidingo ezahlukahlukene.

Amasethingi

Izinsizakalo ze-CDMO zama-plasmid
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 ● I-GMP - Njenge-workshop ● I-GMP - njengohlelo lokuphathwa kwekhwalithi ● Imibhalo eyiqiniso nethosiwe
	2	Indalo yeBacteria Bank (GMP - Like)	● Inombolo ethambile kanye nokucaciswa kwamabhange ama-bacterium okufanele kwenziwe
	3	Ukukhiqiza kanye nokuhlola (GMP - Like)	● Ukukhishwa okukhiqizwayo okuhambisana nokucaciswa

* Qaphela: Sinikeza izinguquko eziguquguqukayo futhi ezihlelwe ngezifiso ezingenhla kwezinsizakalo, kufaka phakathi kepha kungakhawulelwe ezinsizakalweni ezingenhla.

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	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

* Qaphela: IHillgene isungule izindlela ze-QC ezihambelana nezindawo zobuchwepheshe ezahlukahlukene, ngezindlela ze-QC kufaka phakathi kepha kungagcini ezintweni ezingenhla.

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.

Thwebula

Izisombululo ezihlanganisiwe ze-CDMO zemoto - T Cells

Ucwaningo lwakho alukwazi ukulinda - futhi akufanele izimpahla zakho!

I-Flash Bluekitbio Kit iletha:

✓ Lab - Ukunemba Okumkhulu

✓ Ukuthumela okusheshayo emhlabeni jikelele

✓ 24/7 Ukusekelwa Kwesazi