Ukuqalisa
Ku-EVERSSIVE - Ukuvela Kwensimu Yezinto Eziphilayo, Ukuba khona kwe-Hot Cell Residial DNA kuba yinselelo enkulu. Ukuqinisekisa ukuphepha nokusebenza kahle kwe-biologics, ikakhulukazi endaweni evuthayo yokwelashwa kwamaseli, kudinga izindlela ezinamandla zokuthola nokunciphisa i-DNA eyisalayo. Lo mbhalo ukhipha ujule ngokubaluleka kokunciphisa umgcini we-DNA kwi-Biologics, izindinganiso ezilawulwa yimbulunga yonke, izindlela ezivamile zokutholwa, kanye nezingozi ezihambisanayo. Siphinde futhi wethule uJiangsu Hillgene kanye neminikelo yawo ekulawulweni kwekhwalithi ekwelashweni kweseli ngokusebenzisa kwaboI-BluekitUmugqa womkhiqizo.
Ukubaluleka kokunciphisa umnikazi we-DNA nge-biologics
● Ubungozi bokwenqatshwa komzimba
I-DNA esesalayo kusuka kumaseli wokusingathwa ingadala impendulo yokuvikelwa kweziguli ezigulini ezithola izindlela zokwelapha ze-biologic. Lezi zingcezwana zivame ukuqashelwa njengakwamanye amazwe amasosha omzimba, okuholela ekutheni ukwenqatshwa okungenzeka okungenzeka kubhalwe phansi kwe-biologilogic.
● Amazinga Wokulawula I-Ejensi
Ama-ejensi okulawula emhlabeni jikelele ahlele amazinga aqinile ukunciphisa umkhawulo we-Host DNA nge-biologics. Lezi zindinganiso ziqinisekisa ukuthi imikhiqizo yokwelapha iphephile ukuze isetshenziswe, igweme noma imiphi imiphumela emibi ngenxa yokuba khona kwe-DNA yakwamanye amazwe.
● Ukusongelwa ekuPhepha Kwempilo
Ukuba khona kwe-DNA esele e-Biologics kubangela ukuphepha okuqondile ekuphepheni kweziguli. Lokhu kungafaka ukusebenza kwe-Oncogenes noma ukudluliswa kwama-ejenti athathelanayo, okwenza kube okubalulekile ukunciphisa i-DNA eyalelayo kumazinga angabonakali.
Izindinganiso Zokulawula Zomhlaba Wonke Ze-Host DNA Izinsalela
● izwe - imikhawulo ethile
Amazwe ahlukahlukene asungule imikhawulo ehlukahlukene yamazinga amukelekile e-DNA eyamukelekayo kwizinto eziphilayo. Le mikhawulo inqunywa kususelwa ezingcupheni ezingaba khona kanye namakhono wobuchwepheshe bokutholwa kwamanje.
● Izidingo eziqinile zokulawula
Imizimba yokulawula efana ne-FDA, EMA, ne-PMDA babeke imihlahlandlela ephelele yokuqinisekisa ukuthi izinganekwane zihlangabezana namazinga okuphepha. Ukunamathela kule mihlahlandlela kubalulekile ukuze kuvunyelwe kanye nokumaketha kwale mikhiqizo.
● Imihlahlandlela ye-PharmacopoEias '
I-Pharmacopoeias emhlabeni wonke, kufaka phakathi i-USP ne-EP, ukuhlinzeka ngezinqubo ezinemininingwane zokutholwa nokuncishiswa kwe-DRA ESIPHAKATHI I-CELER CELE Cell DNA. Le mihlahlandlela ilandelwa ngamandla ngabakhiqizi ukuqinisekisa ukuphepha komkhiqizo nokuhambisana.
Izindlela ezijwayelekile zokutholwa kwensalela ye-DNA
● Izindlela zemibundu
Izindlela zemibundu zifaka ukusetha umkhawulo wokutholwa noma umkhawulo we-DNA eyinsalela. Uma izinga le-DNA lisesampule lidlula lo mbundu, kukhombisa ukuba khona kwamazinga angamukeleki we-DNA yensalela.
● Amasu we-Hybridization
Amasu we-Hybridization, anjenge-Southern Breeng, asetshenziselwa ukuthola ukulandelana kwe-DNA okuthile kwisampula. Lezi zindlela zicacisiwe kakhulu futhi zikwazi ukubona amanani amancane we-DNA eyinsalela.
● Iqiniso - Isikhathi se-Time Pcr
Okungokoqobo - Isikhathi se-PCRITITITION PCR (QPCR) kungenye yezindlela ezibucayi kakhulu futhi ezisetshenziswe kabanzi zokuthola i-DNA eyinsalela. Ingancamela i-DNA ngokunemba okuphezulu, okwenza kube yithuluzi elibalulekile lokuqinisekisa ukuphepha kwemikhiqizo ye-biologic.
Ukuchazwa kanye nobungozi be-Hot Cell Residium DNA
● Izingcezwana ze-DNA ezibanjelwe e-Biologics
I-Pist Cell Remidapy DNA ibhekisela izingcezwana ze-DNA ezivela kumaseli asetshenziselwa ukukhiqiza izikebhe. Lezi zingcezwana zingahluka ngosayizi nokulandelana, zibonisa amazinga entengo ahlukahlukene ezigulini.
● Izingozi ezingaba khona kusuka isimila - izinhlobo ezihlobene
I-DNA eyinsalela ingaqukatha ukulandelana okuhlobene neTamos. Uma lokhu kulandelana kuhlangana ku-genome yesiguli, kungasebenza nge-OCOGEENE, okuholela ekuthuthukisweni komdlavuza.
● Igciwane - Okuhlobene Nhlobo Ufuzo
I-DNA esesalayo nayo ingafaka ukulandelana kwama-virus asetshenziswe kwinqubo yokukhiqiza. Lokhu kulandelana kwamagciwane kungabeka engcupheni yokutheleleka ngegciwane noma ukuvuselelwa kwegciwane, okwenza ukutholwa kwazo nokususwa okubalulekile.
Izibonelo zezingozi ezibangelwe yi-DNA eyinsalela
● Igciwane le-HIV ezingcupheni ze-DNA
Izingqinamba ze-DNA ezisele ezibandakanyeka nge-HIV zingaba sengozi enkulu yokutheleleka. Ukuqinisekisa ukuthi izinganekwane zikhululekile kulokulandelana okunjalo zibalulekile ekuphepheni kweziguli.
● ubukhona be-ras oncogene
Ukuba khona kwama-ras oncogene e-DNA eyinsalela kungaholela ekuhlukaniseni kweseli okungalawulwa kanye nomdlavuza. Ukuthola nokususa lokhu kulandelana kubalulekile ukuvikela imiphumela emibi enjalo.
● ulayini - 1 ukulandelana kokufaka ku-chromosomes
I-Line - Ukulandelanisa okungu-1 ama-retrotranspos angahlanganisa ku-genome futhi aphazamise umsebenzi ojwayelekile wofuzo. Ukuba khona kwabo kwi-biologics kubangela ingozi enkulu futhi kugcizelela isidingo sezindlela ezisebenzayo zokutholwa kwezindawo ze-DNA.
Umthelela wokufakwa kwe-DNA okusalayo kwimisebenzi ye-gene
● ukwenza kusebenze ama-oncogene
Ukufakwa kwe-DNA okusele kungasebenza ama-Oncogenes, okuholela ekwamukelweni okungalawulwa kwamaseli. Lokhu kungaholela ekuthuthukisweni kwamathumbu namanye ama-malignancies.
● Ukuvinjwa kohlobo lwe-tumor supressor
I-DNA esele nensalela futhi ingaphazamisa ufuzo lwe-Smouse Prosresser, olubalulekile ukulawula ukukhula kwamaseli. Ukuvimbela lezi zifuzo zingasusa amasheke namabhalansi ekwakhekeni kwamaseli, okuholela kumdlavuza.
● imisebenzi ye-retrotranspos
I-retrotranspos, efana nelayini - 1, ingakopisha bese uzifaka ngezindawo ezintsha ngaphakathi kwe-genome. Lo msebenzi ungaphazamisa ukusebenza okujwayelekile kofuzo futhi ufake isandla ekusebenzeni kofuzo.
I-Microbial genomic DNA ne-Immunogenicity
● Ukulandelana kwe-CPG nokungahambisani
I-Microbial genomic DNA ivame ukuqukethe ama-motifs e-CPG afakiwe, aqashelwa amasosha omzimba njengezimpawu eziyingozi. Lezi zisusa zingadala impendulo yokuzivikela komzimba, okuholela ekuvuvukeni neminye imiphumela emibi.
● Ubungozi obuhambisana nezidakamizwa eziphindaphindwayo
Izidakamizwa eziphindaphindwayo zamaphrotheni, ezikhiqizwe zisebenzisa ama-microbial hoste, zingathwala i-DNA eyinsalela eyinsalela. Lokhu kubeka engcupheni yokuvuselela amandla neminye imiphumela emibi, kudinga ukutholwa okunomunwe nezinqubo zokususa.
● Ama-motifs we-CPG aqala ukuvusa ubuntu
I-CPG Motifs ye-CPG eyenziwe nge-CPG ye-Dridial Microbial DNA ingasebenza kusebenze intela - njengama-receptors kumaseli omzimba, okuholela ekuphenduleni kokuvuvukala. Lokhu kusebenza komzimba kungahlehlisa ukuphepha nokusebenza kahle kwezindlela zokwelapha ze-biologic.
Ukuhlaziywa kokuqhathanisa kwezitalati nobungozi obuthelela
● Ubungozi bezindlebezi qhathanisa nezingozi ezithathelwanayo
Izingozi ezibangelwa yi-DNA eyinsalela zingahlukaniswa kabanzi zibe yizitha ze-amome kanye nezingozi ezithelelekayo. Ngenkathi izingozi zamahlanga zibandakanya ukusebenza kwe-Oncogenes noma ukuphazamiseka kofuzo lwe-supresresresressor, ubungozi obuthelela kuqondene nokudluliselwa kwegciwane noma ukulandelana kwamagciwane noma amagciwane.
● Ukuhlolwa kwezilwane zesikhamizi
Izilingo zezilwane zivame ukwenziwa ukuze zihlole amandla avumbala we-DNA asele. Lezi zifundo zibandakanya ukujova imikhiqizo ye-biologic ezilwaneni nasekuqapheleni ukuthuthukiswa kwama-tumors ngokuhamba kwesikhathi.
● Izinga lamaselula okuzama okuthelelekayo
Izingozi ezithathelwanayo zihlolwa ngokuhlolwa kwamaselula, lapho imikhiqizo ye-biologic ihlolwe ukuba khona kokulandelana kwamagciwane noma amagciwane akwazi ukudala ukutheleleka. Lezi zivivinyo zibalulekile ekuqinisekiseni ukuphepha kwe-biologics.
Izindlela zokuvimbela namazinga aqinile
● Izindinganiso zokutholwa kwezinto eziphilayo
Kusungulwe izindinganiso eziqinile zokutholwa kwe-DNA eyalelayo kwezinto eziphilayo. Lezi zindinganiso ziqinisekisa ukuthi imikhiqizo kuphela ekhululekile ekulandelweni kwe-DNA okuyingozi ifinyelela emakethe.
● Ukunciphisa ubungozi obungaba khona bezempilo
Ukunciphisa i-DNA eyinsalela kwezinto eziphilayo kubalulekile ukuze kuncishiswe ubungozi bezempilo. Abakhiqizi basebenzisa izindlela ezahlukahlukene zokuhlanzwa kanye nezindlela zokuthola ukuqinisekisa ukuthi imikhiqizo yabo iphephile ukuyisebenzisa.
● Ukulandela umthetho wokulawula
Ukunamathela kwimihlahlandlela yokulawula yokutholwa kwe-DNA okuyisisekelo kubalulekile ukuthola imvume nokumaketha kwemikhiqizo ye-biologic. Ukuhambisana nalezi zinkombandlela kuqinisekisa ukuthi imikhiqizo ihlangabezana nezindinganiso eziphakeme kakhulu zokuphepha kanye namazinga okusebenza kahle.
Izinkomba zesikhathi esizayo kucwaningo lwe-Host DNA Residial Research
● Ukuthuthukisa Izindlela Zokutholwa
Inkambu yokutholwa kwensalela ye-DNA iyavela njalo, ngezindlela ezintsha ezenziwayo ukuze kuthuthukiswe ukuzwela nokucaciswa. Lezi zithuthuka zibalulekile ukuze kuqinisekiswe ukuphepha kwemikhiqizo ye-biologic.
● Ukunciphisa ubungozi obusalelayo kwezinto eziphilayo
Ucwaningo oluqhubekayo luhlose ukuthuthukisa amasu amasha okuhlanza kanye nezinqubo zokukhiqiza ukunciphisa i-DNA eyinsalela kwizinto eziphilayo. Le mizamo ibalulekile ekunciphiseni ubungozi obuhambisana nezindlela zokwelapha zemvelo.
● Ukuthuthukisa amazinga okuphepha kwezidakamizwa
Ukwenza ngcono izindlela zokutholwa nokwehlisa ubungozi obuyinsalela kubalulekile ekuthuthukiseni amazinga okuphepha ezidakamizwa ze-biologic. Lezi zithuthuka zizoqinisekisa ukuthi izindlela zokwelapha ze-biologic zihlala ziphephile futhi zisebenza ezigulini.
Jiangsu Hillgene kanye ne-BlueKit® Inzuzo
UJiangsu Hillgene, ubhekise eSuzhou, eChina, enezindawo zokukhiqiza eShenzhen naseShanghai, kanye nesiza esakhiwa eNorth Carolina, e-USA, kusengaphambili kokusungulwa kwezingcingo ekwelashweni kweseli. Umugqa womkhiqizo wabo we-BlueKit® ufaka amakhithi wokuthola izinsalela zemvelo kanye nemisebenzi ekukhiqizweni kwezidakamizwa, eqinisekisa ukuphakama - amazinga okulawulwa kwekhwalithi. Amapulatifomu kaHillene asekela ukuthuthukiswa kwemoto - T, TCR - T, kanye neseli le-stem - Imikhiqizo esekwe, okuhlose ukuletha imikhiqizo yokwelashwa yamaselula, futhi ubeke ama-milestones amasha ekwelashweni kweseli.
Ukugcina
Ukuqinisekisa ukuphepha kwezinto eziphilayo kubandakanya ukutholwa ngokucophelela nokuncishiswa kwe-DNA ye-Residial Host Cell. Ukunamathela kumazinga alawulwa yimbulunga yonke kanye nokusebenzisa izindlela zokutholwa okuthuthukile ziyizinto ezibalulekile ekunciphiseni ubungozi obubangelwe yi-DNA eyinsalela. UJiangsu Hillgene, ngomugqa wabo we-BlueKit®, uyisibonelo sokuzibophezela ekuphathweni kwekhwalithi ekwelashweni kweseli, kugoqa indlela yezindlela zokwelapha eziphephile nezisebenzayo.
Isikhathi Seposi: 2024 - 09 - 25 14:38:04
