Isingeniso ekuhlolweni kwe-DNA okusele
Ukuhlolwa kwe-DNA okusele kubhekisele ezindleleni zokuhlaziya ezisetshenziselwa ukuthola nokulandela amanani we-DNA asele emikhiqizweni ye-biopharmaceutical ngemuva kwezinqubo zokukhiqiza ngemuva kokukhiqiza izinqubo. Lolu hlobo lokuhlola lubalulekile ekuqinisekiseni ukuphepha nobumsulwa be-biologics, kufaka phakathi ukwelashwa kwamaselula, imigomo, nama-antibodies wezokwelapha. Ukuba khona kwe-DNA esesalayo kuma-biopharmaceuticals, ikakhulukazi i-DNA isuka kumaseli abanjengo anjenge-E.Coli, ibeka izingozi ezingaba khona kufaka phakathi i-Immunogenicity nezithambisi. Ngakho-ke, ukuhlolwa kwe-DNA okusalayo okuqinile kuyingxenye ebalulekile yokulawulwa kwekhwalithi ekukhiqizweni kwe-biopharmace.
● Ukuchazwa kanye nokubaluleka
Ukuhlolwa kwe-DNA okusele kufaka phakathi ukutholwa nokuncishiswa kwezingcezwana ze-DNA ezisele kusuka kumaseli asemqondweni asetshenziswa ngesikhathi sokukhiqizwa kwe-biologics. Lezi zingcezwana zingahluka ngosayizi nenani, futhi amanani emisha angabaluleka. Ukubaluleka kokuhlolwa kwe-DNA okusele akunakuqedwa - kuqinisekisa ukuthi ama-biopharmaceuticals ahlangabezana nezindinganiso zokulawula ukuphepha nokusebenza ngempumelelo, ngaleyo ndlela avikele impilo yeziguli.
● Sebenzisa ukulawulwa kwekhwalithi
Ukulawulwa kwekhwalithi ekukhiqizeni kwe-biopharmaceutical kubandakanya izigaba eziningi, kusuka ekuqinisekisweni okubonakalayo okungavuthiwe ekuhlolweni komkhiqizo wokugcina. Ukuhlolwa kwe-DNA okuseleyo kuyisigaba esibalulekile ngaphakathi kwaloluhlaka. Iqinisekisa ukuthi izinqubo zokuhlanza zisuse ngempumelelo izinto zofuzo ezingafuneki, ukuqinisekisa ukuhambisana komkhiqizo wokugcina ngemihlahlandlela yokuphepha ebekwe yiziphathimandla ezilawulayo njenge-FDA ne-EDA.
Indima ye-DNA eyakhayo kuma-biopharmaceuticals
● Izinhlobo zama-biofarmaceuticals
I-biopharmaceuticals ehlanganisa izinhlobo eziningi zemikhiqizo, kufaka phakathi ama-antibodies e-monoclonal, amaprotheni aphindaphindwayo, imigomo, kanye nokwelashwa kwamaselula. Isigaba ngasinye sinezinqubo ezihlukile zokukhiqiza, kepha zonke zitholakala ekungcoleni okusalayo kwe-DNA.
● Imithombo ye-DNA yensalela
I-DNA esele ngokuyinhloko ivela kumaseli wokusingathwa asetshenziswa kwinqubo yokukhiqiza. Amangqamuzana ajwayelekile abanjelwe afaka amaseli ama-bacteri anjenge-E.Coli, amaseli wemvubelo, amaseli wezilwane, kanye namaseli ezinambuzane. Ngesikhathi sokukhiqizwa kwama-biopharmaceuticals, la maseli anwetshwa ukuvuna umkhiqizo owuthandayo, kungenzeka akhulule izinto zawo zofuzo kwingxube.
Izimiso zeTaqman Probe ekutholweni kwe-DNA
● I-Mechanism of Action
I-Taqman Probe - I-Assay esekelwe yindlela esetshenziswa kabanzi yokutholwa kwensalela ye-DNA. Le ndlela isebenzisa uphenyo olubhalwe ngobuhlakani olubhalwe ngokulandelana kokulandelana kwe-DNA. I-Taq Polymerase Enzyme yabe isinamathisela i-probe ngesikhathi senqubo ye-PCR Amplification, ihlukanisa udayi we-fluorescent kusuka ku-juencher futhi ikhiqize isiginali ebonakalayo.
● Izinzuzo zeTaqman Probe
Enye yezinzuzo eziyinhloko zombuso weTaqman ukucaciswa kwayo. Amandla kaProbe wokuhlobisa ngokulandelana okuhlukile kuqinisekisa ukuthi kuphela i-DNA eqondisiwe ekhulisiwe futhi itholakele, inciphisa izinzuzo zamanga. Le ndlela inikeza ukuzwela okuphezulu, okwenza kube kuhle ukuthola amazinga aphansi we-DNA esele.
E.coli njengeseli lokusingathwa kuma-biopharmaceuticals
● Kungani u-E.Coli evame ukusetshenziswa
I-E.COLI iseli elithandwayo eliyisihlokweni e-biotechnology ngenxa yokukhula kwalo ngokushesha, kahle - i-genetics ebonakaliswayo, kanye nekhono lokuveza amaphrotheni aphezulu amaprotheni aphindaphindwayo. Lezi zimfanelo zenza i-E.Coli ibe yizindleko - Ukukhetha okusebenzayo nokusebenzayo kokukhulu -
● Imiphumela ye-residual e.coli DNA
Naphezu kwezinzuzo zayo, ukusetshenziswa kwe-E.Coli kuza nengozi yokungcoliswa kwensalela ye-DNA. Le DNA eyinsalela ingabeka ukukhathazeka ngokuphepha, njengethuba lokudluliselwa kwezakhi zofuzo noma ukuba khona kwe-endotoxins. Ngakho-ke, izindlela zokuhlola eziqinile ze-DNA zibalulekile lapho usebenzisa i-E.coli njengomgcini wokukhiqiza.
Izindlela zokutholwa kwezilinganiso
● Amasu asetshenziswe ngokwengeziwe
Amasu ambalwa aqashwa ngokutholwa kwenani le-DNA esesalayo, kufaka phakathi i-QPCc, iDijithali PCR, futhi Okulandelayo - Ukulandelana Kwezizukulwane. Indlela ngayinye inikezela ngezinzuzo ezahlukene ngokuya ngokuzwela, ukucaciswa, kanye nokusebenzisa.
● Ukuzwela nokunemba
Ekuhlolweni kwe-DNA okusele, ukuzwela nokunemba kubaluleke kakhulu. Amasu anjenge-qpcr ne-digital PCR angathola i-DNA emazingeni e-femntogram, enikeza ukuzwela okuphezulu okudingekayo ukuqinisekisa ukuphepha komkhiqizo. Ukunemba kubalulekile ngokulinganayo, ngoba kuqinisekisa ukuthembeka kwemiphumela yokuhlola, okuvumela isinqumo sokuqiniseka - Ukwenza kulawulo lwekhwalithi.
Ukubaluleka kokutholwa kwezinga le-FG
● Ukuchazwa Kwezinga le-FG
Izinga le-FG libhekisela kuma-femntograms, iyunithi lokulinganisa elimele i-10 ^ - Amagremu ayi-15. Ukuthola i-DNA kuleli zinga le-femntogram kukhombisa ukubonwa okubucayi kakhulu okukwazi ukukhomba amanani wokulandela umkhondo wezinto zofuzo.
● Ukubaluleka kokuzwela okuphezulu
Ukuzwela okuphezulu ekuhlolweni kwensalela ye-DNA kubalulekile ekuqinisekiseni ukuphepha kwama-biopharmaceuticals. Ukuthola i-DNA ezingeni le-FG kuvumela ukukhonjwa ngisho nokungcoliswa okuncane kakhulu, ukuqinisekisa ukuthi umkhiqizo wokugcina ucwebezele ngangokunokwenzeka futhi uhlangane namazinga aqinile alawulayo.
Izindlela zokulawula zekhwalithi ngokukhiqizwa kwe-biopharmaceutical
● Udinga ukuhlolwa kwe-DNA okusele
Isidingo sokuhlolwa kwe-DNA okusalayo ekukhiqizeni i-biopharmace avela ezingozini ezingaba khona ezihambisana nokungcoliswa kofuzo. Ama-ejensi okulawula agunyaza imikhawulo eqinile emazingeni e-DNA asele, adinga izindlela zokuhlola ezinzima zokuqinisekisa ukuhambisana.
● Izindinganiso Zokulawula
Izindinganiso zokulawula ze-DNA ezisalayo ziyahlukahluka ngokuya ngohlobo lwe-biofarmaceutical. Isibonelo, i-FDA ne-EMA zisungule imihlahlandlela echaza imikhawulo eyamukelekayo ye-DNA eyanele emikhiqizweni ehlukene. Ukubambelela kulawa mazinga kubalulekile ekuvunyelweni komkhiqizo nokukhululwa kwemakethe.
Izicelo ekukhiqizeni kabusha amaprotheni
● Izifundo ezikhethekile zamacala
Ekukhiqizweni kwamaprotheni kabusha, ukuhlolwa kwensalela kwe-DNA kubalulekile ekuqinisekiseni ubumsulwa bomkhiqizo. Izifundo ezikhethekile zecala ziqokomisa ukusetshenziswa ngempumelelo kweE.coli DNA desidial kitSokubheka nokulawula amazinga okungcolisa ama-DNA, ukuqinisekisa ukuhambisana namazinga okulawula.
● Ukuqinisekiswa kwekhwalithi
Ukuqinisekiswa kwekhwalithi ekukhiqizweni kwamaprotheni kabusha kuhlanganisa izingqimba eziningi zokuhlola nokuqinisekiswa. Ukuhlolwa kwe-DNA okuseleyo kudlala indima enkulu kule nqubo, ukuhlinzeka ngemininingwane edingekayo ukuqinisekisa ukuthi izinqubo zokuhlanza zisuse ngempumelelo ukungcoliswa kwezakhi zofuzo.
Izinselelo Ekuhlolweni Kwezinsalela ze-DNA
● Ubunzima bobuchwepheshe
Enye yezinselelo eziyinhloko ekuhlolweni kwensalela ye-DNA ngobuchwepheshe bobuchwepheshe bokuthola nokuthola amazinga aphansi we-DNA. Izici ezifana ne-Tamp Matrix, i-DNA Fgvermental, kanye nokuvinjwa kwe-Assay kungaba yinqubo yokuhlola.
● Ukunqoba izithiyo ezivamile
Ukunqoba lezi zingqinamba kudinga ukusetshenziswa kwamasu athuthukile kanye nezinqubomgomo ezenzelwe kahle. Abakhiqizi kanye nabaphakeli be-E.Coli DNA abasalayo kits basebenza ngokuqhubekayo ukucwilisa imikhiqizo yabo, ukuthuthukisa ukuzwela nokucaciswa ukuze kuhlangatshezwane nezidingo zomkhakha.
Amathrendi wesikhathi esizayo ekuhlolweni kwe-DNA okusele
● Intuthuko yezobuchwepheshe
Intuthuko yezobuchwepheshe ilungele ukuguqula ukuhlolwa kwe-DNA okusele. Izinto ezintsha ezinjenge-Crispr - Ama-Agays asuselwa ku-PCR, futhi Okulandelayo - Ukulandelana Kwezizukulwane kunikeza izindlela ezintsha zokutholwa okubucayi nokucacile kwe-DNA.
● Amasu avelayo namathuluzi
Amasu avelayo namathuluzi esithembisweni se-DNA esisele sokuthuthukisa ukuthuthukisa ukunemba nokusebenza kahle kwezindlela zokulawula ikhwalithi. Lezi zithuthuka zizonika amandla abakhiqizi be-biopharmaceutical ukuthi bahlangane ngokwengeziwe amazinga aqinile okulawulwa ngenkathi kuqinisekisa ukuphepha komkhiqizo.
Ukugcina
Ukuhlolwa kwe-DNA okuseleyo kuyingxenye ebucayi yokulawulwa kwekhwalithi ekukhiqizweni kwe-biopharmace. Ukutholwa kanye nokuncishiswa kwezimali ze-TRACE ze-DNA kubalulekile ekuqinisekiseni ukuphepha nokusebenza kahle kwe-biologics. Amasu athuthukile afana neTaqman Probe anikela ngokuzwela nokucaciswa okudingekayo ukuze ahlangabezane namazinga alawulayo. Njengoba imboni iqhubeka nokuvela, izinto ezintsha ekuhlolweni kwensalela ye-DNA izodlala indima ebalulekile ekugcineni amazinga aphezulu wekhwalithi yomkhiqizo.
● CisheI-Bluekit
UJiangsu Hillgene, ngaphansi kwegama le-Brand Bluekit, wasungula indlunkulu yayo eSuzhou ngezitshalo eziyi-10,000 000 GMP kanye ne-R & D Centre. Ngezindawo zokukhiqiza eShenzhen, eShanghai, kanye nesiza esisha esakhiwa eNorth Carolina, eHillingGene kukhulisa ubukhona bayo bomhlaba wonke. Le nkampani isebenza ngokuthuthukiswa kwamakhithi okulawulwa kwekhwalithi yemikhiqizo yokwelashwa kwamaselula, ukusekela abalingani ekuthuthukisweni okuphumelelayo kwemoto - t, tcr - t, iseli elisekelwe. I-Bluekit izibophezele ekuthuthukiseni amaselula okusha kanye nokuhlinzeka ngezisombululo ezinikezele zemikhiqizo yokwelapha amaselula.
Isikhathi Sokuthumela: 2024 - 09 - 23 14:17:04
