Imvelaphi yoPhando kunye noBalulo
Kwimveliso yokugonya ye-FMD, izinto ezivelisa i-cell culture supernatants ziqulathe inani elikhulu leenkunkuma zeseli. Ukuba zifakwe ngqo kwi-0.2 μm sterilizing filtration, ii-filter membranes zinokungcola ngokukhawuleza, nto leyo enciphisa ukusebenza kakuhle kwaye inokuchaphazela ukungena kunye nokuveliswa kwe-antigen ekujoliswe kuyo (ii-146S viral particles).
Olu phononongo lugxile kwimibuzo emithathu ebalulekileyo:
Ukuthelekisa ukusebenza kokuhluzwa komphezulu kunye nokuhluzwa kobunzulu ngokwendlela ophuma ngayo, ukunciphisa ukudumba, kunye nokukhusela izihluzi zokubulala iintsholongwane ezisezantsi.
Ukuqinisekisa inzuzo ekhethekileyo yezihluzi zobunzulu ezitshajiweyo kakuhle ekususweni kobumdaka beeseli.
Ukuseka iinkqubo zokucoca ezinokulinganiswa ezilungiselelwe ulwelo lokukhulisa izityalo olunamanqanaba ahlukeneyo okudumba, ukuze kuhlangatyezwane neemfuno zemveliso yemizi-mveliso.
Iimvavanyo eziphambili kunye neziphumo
Ukuhluzwa koMphezulu vs. Ukuhluzwa koBunzulu
Uvavanyo:Ulwelo lwe-FMD olungasebenziyo luhluziwe kusetyenziswa i-0.45 μm polypropylene surface membrane kunye namaphepha esihluzo sobunzulu, kulandele i-0.2 μm sterilizing filtration.
Iziphumo:
Ukuqala kokungcola: 77 NTU.
Ukuhluza ubunzulu:umthamo wokuphuma kwegesi yi-641 L/m²; ukufuma kwegesi kuncitshisiwe ukuya kwi-9.65 NTU (kucacile kwaye kukhazimlayo).
Ukuhluza umphezulu:amandla okukhupha amanzi ayi-46 L/m² kuphela; ukudumba kwahlala kuyi-41 NTU.
Ukucoca iintsholongwane okuya ezantsi:Emva kokuhluzwa kobunzulu, izihluzi ze-0.2 μm zazinomthamo we-655 L/m², xa kuthelekiswa ne-91 L/m² kuphela emva kokuhluzwa komphezulu—uphuculo lwe-7.2 ×.
Isivuno se-146S:Ukucoca okunzulu kakhulu kunakwi-surface filtration.
Isiphelo:Ubunzulu bokuhluza bungaphezulu nge-13.9× kunokucoca okungaphezulu, ukutshabalala kwe-filtrate bekuphantsi nge-76.5%, kwaye ubomi bokucoca iintsholongwane buye bandiswa ngaphezu kwe-7×. Ngokwembono yexabiso kunye neyokuvuna, ukuhluza okunzulu kungcono.
Itshajiwe kakuhle xa kuthelekiswa ne-Strongly Positively Charged Depth Filtration
Uvavanyo:Iindidi ezimbini zeeshiti zokucoca ubunzulu ezinobukhulu obufanayo beembobo kodwa uxinano lwetshaja olwahlukileyo (oluqhelekileyo olune-positive vs. olune-positive enamandla) zavavanywa kwiilwelo ze-FMD ezingasebenziyo.
Iziphumo:
Iiprofayili zokukhupha kunye noxinzelelo bezifana.
Ubunzulu obuqhelekileyo obuhleisihluzo:i-filterrate turbidity 25 NTU.
Ubunzulu obuqinileyo obuqinisekileyoisihluzo:i-filtrate turbidity 9.65 NTU (yi-38.6% kuphela yesiqhelo).
Umthamo wokutshaja onamandla uvela kwii-ligand ezikhethekileyo ze-resin eziphucula ukutsalwa kwe-electrostatic.
Iingxelo zeencwadi ziqinisekisa ukuba izihluzi zobunzulu eziqinileyo zinokususa iiproteni zeseli zomninimzi (i-HCP) kunye ne-DNA.
Isiphelo:Izihluzi zobunzulu eziqinileyo nezilungileyo zibonelela ngokunciphisa ukungcoliswa kwamanzi ngcono kakhulu (<10 NTU), zikhusela ukuhluzwa kwe-ultrafiltration/sterilizing filter ngezantsi, kwaye zisusa ukungcola okongezelelweyo okunxulumene nenkqubo.
1. Imigaqo yoBugcisa kunye neeNzuzo zoBuchule bokuHlambulula
Ukuhluza umphezulu:Ibamba amasuntswana kuphela kumphezulu we-membrane; ikakhulu ukurhangqa okusekwe kubukhulu.
Ukuhluza ubunzulu:Isusa amasuntswana kuyo yonke i-matrix ngokufaka i-entrapment kunye ne-electrostatic adsorption.
Iingenelo eziphambili:
Akukho asbestos (ngokungafaniyo ne-filter media yokuqala).
Yenziwe ngeefayibha ze-cellulose ezicocekileyo kakhulu, izixhobo zokucoca, kunye nee-resin ze-polymeric.
Amaqela asebenzayo anetshaji elungileyo anika ukufunxwa okunamandla kwamasuntswana amancinci kunye nokungcola.
Ihambelana ngokupheleleyo neemfuno zolawulo lwe-biopharmaceutical.
2. Iinkqubo zokuhluza ezinokukhula kwiinqanaba ezahlukeneyo zokuTshintsha kobushushu
Ngokusekelwe kwizifundo zokuthelekisa:
Iphantsiukudumbaulwelo:ukuhluzwa okukhaphukhaphu okwaneleyo.
Phakathiukudumbaulwelo:Kucetyiswa ukuhluza ubunzulu obuneeleya ezimbini.
Phezuluukudumbaulwelo:Kufuneka ukuhluzwa kobunzulu obuqinileyo ukuze kuncitshiswe ukudumba okungaphantsi kwe-10 NTU, ukuqinisekisa ukucutshungulwa okusebenzayo komlambo kunye nemveliso ephezulu ye-antigen.
3. Ukuphunyezwa kweMveliso: IiFiltration Depth Filtration Filtration Filters zeGreat Wall
I-Great Wall Filtration inikezela ngeenkqubo zokucoca ubunzulu ezenzelwe iinkqubo ze-biopharmaceutical.
Ezona mpawu:
Amaphepha esihluzo esinobunzulu obuphezulu sokususa iiseli, inkunkuma, kunye nezinto ezinkulu eziqinileyo.
Isebenza kwiinkcubeko zeeseli zezilwanyana ezincancisayo, iibhaktiriya/i-yeast lysates.
Iyakwazi ukususa i-HCP, i-DNA, iintsholongwane, ii-endotoxins, kunye nee-antifoaming agents.
Uyilo oluncinci, olunokulinganiswa ngokuthe ngqo, olufanelekileyo ukusetyenziswa ngaphakathi okanye ngaxeshanye.
Amanqanaba okuhamba kombane azinzileyo, ubomi benkonzo ende, kunye neendleko zokusebenza eziphantsi.
Isiphelo
Itekhnoloji yokucoca ubunzulu obutshajwe kakuhle iphucula kakhulu ukusebenza kakuhle kokucacisa kunye nokubuyiselwa kwe-antigen kwimveliso yegonyo le-FMD. Ngaphaya kwegonyo le-FMD, ibonelela ngendlela ethembekileyo yokucoca kwezinye izinto eziphilayo. Njengoko ukuphuculwa kwe-bioprocess kuqhubeka, itekhnoloji yokucoca ephucukileyo iya kuhlala ibalulekile ekwenzeni igonyo ngokukhuselekileyo nangokufanelekileyo.
Eli nqaku lisekelwe kwidatha yovavanyo yokwenyani ukuze kubhekiselwe kuyo kuphela.Ukuqinisekiswaphantsi kweemeko zokwenyani zemveliso kuyacetyiswa.
