CDMO Auaunaga mo Denntivierm vectoralp - Initia

Lentivirus, o se subtype o reprovirus, mafai ona tuʻufaʻatasia o le 'au aloalo i totonu o le' '' 'auala o le sela o le ata, ma e masani ona faʻaaogaina o le viod inisinia. Faatasi ai ma le faʻaalia o togafitiga cebour mo le tele o maketi mo le faʻateleina o vaʻa o le lalolagi. Highgene o loʻo faʻapitoa i le aiaiga tuʻufaʻatasia o galuega CDMO o oloa, ua uma ona faʻavaeina se 'auʻaunaga GMP

Tautua

Initia	1	Tutoatasi Sauniuni le fa - Plasmid System	● Tupulaga Lona tolu o le fa - plasmid faiga ● Kanamycin - Resingary Gene ● foaʻiina o le laisene, pe a manaʻomia	● Mulimuli i tulaga mo le lafoina o Saina uma ma matou ● tumu - GMM tagata faigaluega ● Vavae ese nofoaga mo le faia o falevai ● Vaeluaina galuega masani i totonu o le leai - sterile ma spraile nofoaga ● GMM tulaga faʻatonutonu faiga
	2	Fausiaina o gm cell faletupe	● O le fetuunaiga o le numera o faletupe e faia ai ● CECK faletupe tumau suesue
	3	Faiga ma faʻataʻitaʻiga metotia atiaʻe	● Mulimuli i mea e manaʻomia (mataupu i le faʻatulagaina o suiga)
	4	GMP gaosiga o le lentiviral vectors	● O le Biorerator faagaoioiga: 5 ~ 50 l o le le faʻatagaina o le bioretorcorr faʻagasologa ● fua faatatau fua: 2 ~ 30 l (mataupu i le masani ai suiga)
	5	Tofotofoga o le lentiviral vectors	● Tita o le Malo ● Selaina o le Tiber ● Seisi o le Tiber ● Relidratedtual 293t Fale talimalo Dona Susuga ● Residratel 293t talimalo cell Porotini suʻega ● toe tusia e le DNA o le DNA Suʻega ● O loʻo sailia ni suʻega a Benzonal ● E1a / SV40 ● O le toe faʻatulagaina o le suʻega ● dna vaega tele ● viogenous virokines ● le mafai ● mycoplasma ● Itutu
	6	Totogi Totogi	● Tulaga faʻapitoa ● Tulaga ● le saʻo ● laina ma le laina ● Lod
	7	Suesuega Tumau	● Luga - Taimi Tumau ● Faavavega le tumau ● Faʻafitauli Tofia

* Manatua: Matou te ofoina atu ni suiga fetuʻutuʻunaʻi ma faʻapitoa suiga i luga atu o tautua, aofia ai ae le gata i luga o auaunaga.

Lelei

Tulaga lelei o le faʻaaogaina o le matou tulaga mo le serum - Faʻasaoloto le faʻamalologa faʻamalositino

• Free o le meaola - Maua vaega i le taimi atoa o le faʻagasologa

• Faʻaipaina le faʻaaogaina o le gaosiga o le lentiviral vectors

• faʻaaogaina se tasi pusa e tasi o le 50 l o le faʻaoʻo

• Faletupe o le Faletupe i le au talaʻi

• tisipe o oloa mulimuli e faʻaaoga ai le sterile isolator

• Faʻatino ifo le lentivirus system mo le taʻavale - t sela, ma le maualuga o le atoatoa atoatoa

• maualalo gaosiga tau ma le suʻega tau (leai ni manaʻoga o suʻega mo le BSA ma toe faʻaleleia le paycreatic enzymes)

• O nisi taimi e fiafia ai i le Ind o le NMPA o le lentiviral vectors mo Car - T sela

Gaosiga gaioiga

Lelei Puleaina

Mea	Suega o le aitema	Suʻega metotia
Suavai o le seleselega	I le fiafia o le siama e afaina ai	Metotia 3302 o le CHP 2020
Suavai o le seleselega	Toefau - Uctive Lentivirses	Faʻailoaina le City Confil Matu Faʻalapotopotoga
Fualaau faasaina	Foliga mai	Tagavai vaaia
	Susunuina	Metotia 1101 o le chp 2020
	Mycoplasma	Metotia 3301 o le CHP 2020
	pH	Metotia 0631 o le CHP 2020
	Osmolalty	Metotia 0632 o le CHP 2020
	Fuafuaina o George Stuption Restotification	Liu
	Toefausia le talimalo o le sela	Elisa
	Malo o le Tapen (P24)	Elisa
	Faauuina Faaeaina	Tafe le CYTOMMETRY
	Tuluia	Metotia 1143 o le CHP 2020
	Rededalicalise	Elisa
	Residuals talimalo sela DNA	Q - PCR
	Residual E1a Great Transfer	Cop - Faasino Auala
	Respedual SV40 Gree Transfer	Cop - Faasino Auala

* Manatua: Horgegene Standed QC Metotia talafeagai ma isi tekonolosi Pretform, ma QC metotia aofia ai ae le gata i luga o aitema.

Poloketi Matutua

Fuafuaga o le Puleaina o Fuafuaga

Hordgegene Poloketi Vaega, e aofia ai saienitisi O, Poloketi QA ma GMP WORDS, o le a faʻafiafiaina ai le lamolemole ma le faʻagaioiga uma.

Sii mai

Faʻatasia CDMO fofo mo Car - T sela

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