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GMP-TL101 Ka-hortagga Aadanaha CD3 mAb Aqoonsiga Antigen-ka, gudbinta signalka iyo hawlgelinta unugga T
Dulmarka alaabta
Ka-hortagga Aadanaha CD3 mAb (GMP TL101) waxaa loo habeeyay si loo fududeeyo aqoonsiga antigen-ka, gudbinta calaamadaha, iyo firfircoonida unugyada T. Antibody-ka monoclonal-ka ah ayaa qayb muhiim ah u ah cilmi-baarista iyo codsiyada bukaan-socodka ee ku lug leh wax-ka-beddelka unugyada T-ga.
Tilmaamaha Muhiimka ah
● Beddelka ishaarada: Waxay si wax ku ool ah u dhexdhexaadisaa aqoonsiga antigen-ka iyo gudbinta calaamada, taasoo muhiim u ah firfircoonida unugyada T.
● Soo saarista GMP: Waxa lagu soo saaray shuruudo adag oo GMP si loo hubiyo tayada badeecada iyo soo saarista
Gaar ahaan Sare: Gaar ahaan sare ee CD3, hubinta bartilmaameedka saxda ah iyo saameynta bartilmaameedka ugu yar.
● Codsi Ballaaran: Ku habboon codsiyada kala duwan, oo ay ku jiraan cytometry socodka, dhaqanka unugyada, iyo cilmi-baarista daweynta.
Codsiyada
● Cilmi-baarista Immunological: Waxay lagama maarmaan u tahay barashada calaamadaha soo-dhoweynta unugyada T-ga (TCR) iyo dariiqyada firfircoonida.
Horumarinta Daaweynta: Caawinta horumarinta daawaynta ku salaysan unugyada T, oo ay ku jirto daawaynta CAR-T.
● Daraasaadka Kiliinikada: Ku haboon borotokoolka cilmi baarista kiliinikada ee u baahan tayada sare, difaaca jirka ee GMP
Tilmaamaha iyo Baakadaha
● Tilmaamaha:
Lagu heli karo cabbirro kala duwan si loo waafajiyo baahiyaha tijaabada ee kala duwan: 100μg, 500μg, iyo 1mg.
Heerarka tayada sare waxay xaqiijinayaan joogtaynta iyo isku halaynta.
Baakadaha:
Loo keenay sida dareere nadiif ah ama budada lyophilized si ay u sahlanaato isticmaalka iyo kaydinta habboon.
Baakad si loo ilaaliyo daacadnimada iyo waxtarka inta lagu jiro gaadiidka iyo maaraynta.
Kaydinta iyo Xasiloonida
Kaydinta
Isticmaalka muddada gaaban, ku kaydi heerkulka 2-8 ° C.
Kaydinta muddada-dheer, ku hay -20°C si aad u ilaaliso xasilloonida iyo dhaqdhaqaaqa lidka-jirka.
Iska ilaali wareegyada qaboojinta ee soo noqnoqda si aad uga hortagto xaalufka.
Xasilooni
Waxay ilaalisaa xasiloonida xaaladaha kaydinta lagu taliyey, iyada oo hubinaysa waxqabadka la isku halayn karo ee codsiyada cilmi-baarista.
Loogu talagalay adkeysiga, dammaanad qaadida waxtarka muddada dheer.
Tilmaamaha Isticmaalka
Ku qas antibody-ka meel ku haboon ama meel dhexe ka hor inta aanad isticmaalin.
U diyaari oo u isticmaal xalka sida ku cad shuruudaha tijaabada ah ee natiijooyinka saxda ah iyo kuwa la soo saari karo.
Raac borotokoolka khuseeya codsigaaga, hadday tahay cytometry socodka, immunohistochemistry, ama qiimayn hawleed.
Digniin
• Alaabtan waxaa loogu talagalay oo keliya isticmaalka cilmi-baarista oo kuma habboona baaritaannada bukaan-socodka ama codsiyada daweynta.
• U qabo ka-hortagga unugga sida waafaqsan tilmaamaha lagu siiyey si aad u ilaaliso hawlihiisa iyo daacadnimadeeda.
• Wixii arrimo ah ama su'aalo ah, fadlan la xiriir kooxdayada taageerada farsamada si ay u caawiyaan.
• Ku wanaaji cilmi-baaristaada unugyada difaaca ee la isku halleyn karo. Si aad u hesho macluumaad faahfaahsan iyo taageerada alaabta, booqo mareegahayaga.
| Unugyada difaaca jirka ee monoclonal | |
| Codsiyada | Habka milmida: fiirsashada 500 ng/mL ayaa lagula talinayaa, kuwaas oo unugyada T la hawlgelin karo iyo unugyada CD3⁺CD56⁺T si weyn loo ballaarin karo. |
| Dhaqdhaqaaqa noolaha | Heerka ku xidhka unugyada Jurkat waa inaanu ka yarayn 90% |
| Habka dahaarka: | 10 mL PBS buffer (5μg/ml anti-biniaadmi CD3) ayaa la dhex dhigayaa weel T75 at 4°C habeen dhaxdii. Fadlan ka saar PBS oo weelka si tartiib ah ugu dhaq cusbo saddex jeer ka hor intaan la isticmaalin. |
| Endotoxin | |
| Martigaliyaha Hadalka | Unugyada CHO |
| Samaynta | Loo keenay sidii 0.22μm la sifeeyay ee PBS, PH 7.4 |
| Nadiifinta: | Protein A oo laga sifeeyay dhaqamada unugga oo sarreeya |
| Nadiifnimada Imtixaanka QC | > 95 % sida ay go'aamisay SDS-PAGE |
| Deganaanshaha & Kaydinta | 24 bilood at 2℃ ilaa 8℃. Iska ilaali wareegyada qaboojinta ee soo noqnoqda |
| Suulka | Macluumaadka faylka |
 | GMP-TL101_SDS.pdf |
| GMP-TL101_ Xaashida Alaabta.pdf |