Emkhakheni wokunakekelwa kwezinso, izinto ezintsha ziyaqhubeka nokwenza ngcono imiphumela yeziguli, ikakhulukazi kulabo abahlushwa ukwehluleka kwezinso. Enye yalezi zinto ezintsha eziguqula imidlalo yiHollow Fiber Membrane, ingxenye ebalulekile ekwelashweni kwe-dialysis. Le ubuchwepheshe ibe nethonya elikhulu endleleni yokuphatha izifo ezingapheli nezibucayi ngokuthuthukisa ukusebenza kahle nokuphepha kwezinqubo zokuhlanza igazi. Njengoba isidingo samadivayisi ezokwelapha athembekile futhi asezingeni eliphezulu sikhula, izinkampani ezifana neStellar Biotech Limited, ezinezindawo ezimbili ezinkulu eSingapore naseHong Kong, zidlala indima ebalulekile ekuthuthukiseni lezi zixazululo ezibalulekile zezempilo.

I-membrane ye-fiber eyimbotshana iwuhlobo lwe-membrane ye-semipermeable enesimo esifana ne-fiber encane, eyimbotshana evumela ukuhlukaniswa okukhethiwe kwezinto. Lezi zimbotshana zisebenza njengeziteshi ezincane lapho igazi lihlungwa khona ngesikhathi sokwelashwa nge-dialysis, okulingisa umsebenzi wokuhlunga wazo zonke izinso ezinempilo. Isakhiwo se-membrane eyimbotshana esinemingqikithi sivumela imfucuza kanye noketshezi olweqile ukuthi ludlule ngenkathi kugcinwa izakhiwo ezibalulekile zegazi. Lokhu kudlula okukhethiwe kubalulekile ekwelashweni kwe-dialysis ephumelelayo, okwenza ama-membrane we-fiber ayimbotshana akhethwe kakhulu kumadivayisi okwelapha izinso.

Ama-membrane avame ukwenziwa ngama-polymer ahambisana nomzimba njenge-polysulfone noma i-polyethersulfone, anikeza ukuqina okuhle nokuhambisana nomzimba. Umklamo wawo wandisa indawo engaphezulu ngaphakathi kwemodyuli encane, okwenza kube lula ukususa ubuthi ngempumelelo ngisho nasezikhathini zokuhlanzwa kwegazi eziqhubekayo. Ngaphezu kwalokho, amamodyuli e-hollow fiber membrane angakwazi ukwenziwa ngokwezifiso ukuze ahlangabezane nezidingo ezithile zokuhlanzwa kwegazi, anikeze ukuguquguquka kuzo zonke izidingo ezahlukene zeziguli.

Ekugcineni kwezinso, ukuqonda indima ye-membrane kusiza odokotela ukuthi balungise izindlela zokwelapha futhi bathuthukise ukuphepha kweziguli. Amandla e-hollow fiber membrane okulingisa imisebenzi yezinso yemvelo aveza ukubaluleka kwayo ezinhlelweni zokuhlanzwa kwegazi zesimanje.

Ukusetshenziswa kwamalwelwe anezimbobo emgqeni emithanjeni yegazi sekuguqule izindlela zokwelapha zeziguli ezinokungasebenzi kwezinso. Kulabo abahlushwa isifo sezinyo esingapheli (CKD) noma ukulimala kwezinso okungazelelwe (AKI), ukuhlanjululwa kwegazi kuvame ukuba ukwelashwa okusindisa impilo okubuyisela umsebenzi wezinso olahlekile. Amamojuli amalwelwe anezimbobo emgqeni avumela ukuhlanzwa kahle kwegazi ngokuhluza ubuthi, izinto ezilimaza umzimba, namanzi ngokweqile.

Enye yezinzuzo eziyinhloko zokusebenzisa amalwelwe anezimbobo emgqeni emithanjeni yegazi ukuthi anomfutho omkhulu nokungena kalula, okuvumela ukususwa okusheshayo kwamamolekyuli amancane naphakathi. Lesi sici sinciphisa isikhathi sokwelashwa futhi sithuthukisa induduzo yesiguli. Ngaphezu kwalokho, umklamo amalwelwe anezimbobo unciphisa ingozi yokujiya kwegazi nokungcola kwamalwelwe uma kuqhathaniswa namalwelwe ayisicaba, kuthuthukisa ukuqina nokwethembeka kwemishini yokuhlanjululwa kwegazi.

Ngaphezu kwalokho, ukuhambisana kombhobho omncane nomzimba (biocompatibility) kusiza ukunciphisa ukusabela okubangela ukuvuvukala ngesikhathi sokwelashwa, okuyinto ebalulekile ekwehliseni izinkinga ezihambisana nokuhlanjululwa kwezinso isikhathi eside. Ngenxa yalokho, iziguli zithola imiphumela engcono kwezokwelapha, izinkinga ezimbalwa ezithinta umzimba, kanye nekhwalithi yokuphila ethuthukisiwe. Lezi zinzuzo ziqinisekisa ukuthi kungani imibhobho emincane (hollow fiber membranes) isalokhu iyisisekelo ekulawuleni ukuhluleka kwezinso.

I-Stellar Biotech Limited isemgqeni ophambili wobuchwepheshe emkhakheni wezempilo, egxile ocwaningweni, ekuthuthukisweni, nokuthengiswa kwemikhiqizo yezokwelapha ethuthukisiwe nemikhiqizo yemithi. Ngobukhona bayo obuyisihumusho esiphindwe kabili e-Singapore nase-Hong Kong, i-Stellar Biotech isebenzisa ubuchwepheshe obudlula izifunda ukuze isheshise ukwethulwa kobuchwepheshe obusezingeni eliphezulu njengama-hollow fiber membrane modules ezimakethe zomhlaba wonke.

Inkampani inikeza ukufinyelela kumikhiqizo engaphezu kuka-1,100 enesitifiketi se-GMP, iqinisekisa ukuthi abahlinzeki bezempilo bangathola izinto zokwelapha ezihambisana nemithetho nezingezekhwalithi ephezulu ngokushesha nangempumelelo. Ngokubambisana nabakhiqizi abahamba phambili, iStellar Biotech iqinisekisa ukuthi uhlu lwayo luhlanganisa izimbotshana zangaphakathi ze-hollow fiber ezisezingeni eliphezulu ezihlangabezana nezindinganiso eziqinile zokuphepha nokusebenza.

Indlela ehlanganisiwe ye-Stellar Biotech ihlanganisa ukuzulazula kwezimiso, ukuqinisekiswa kwekhwalithi, nokuzivumelanisa nemakethe, isiza abahlinzeki bezempilo ukuthi basebenzise ubuchwepheshe be-hollow fiber membrane ngokuzethemba. Lesi sizibopho sobuhle asigcini nje ngokuthuthukisa ukunakekelwa kweziguli kodwa futhi sithuthukisa izinga lomhlaba wonke lobuchwepheshe bokwelapha izinso. Ngeminye imininingwane mayelana nezipho zabo eziphelele, vakashela ikhasi le-Imikhiqizo.

Ukuthobela ukuqinisekiswa kwe-Good Manufacturing Practice (GMP) kubalulekile ukuqinisekisa ukuphepha, ikhwalithi, nokusebenza kahle kwe-hollow fiber membranes esetshenziswa ekwelashweni kwezokwelapha. Amazinga e-GMP afuna abakhiqizi ukuthi bagcine izilawuli eziqinile phezu kwezinqubo zokukhiqiza, ukulawula ikhwalithi, nemibhalo. Lokhu kuqinisekisa ukuthi yonke imodyuli ye-hollow fiber membrane ihlangabezana nezimiso zokusebenza ezingaguquki futhi ayinayo ukungcola.

Kumadivayisi ezokwelapha ahilelekile ekwelashweni okugcina impilo njengokuhlanzwa kwegazi (dialysis), ukuthobela i-GMP kuyinto okungadingidwa. Kuvikela iziguli ngokunciphisa ubungozi obuhlobene nemikhiqizo enesici noma engaphansi kwezinga. I-Stellar Biotech Limited igcizelela ukuthobela i-GMP emikhiqizweni yayo ebanzi, ihlinzeka izikhungo zezempilo ngezixazululo zamamembrane ezingathenjwa ezisekelwa ukuqinisekiswa kwekhwalithi okuphelele.

Ngaphezu kwalokho, ukugcina isitifiketi se-GMP kwenza kube lula ukuthola izimvume ezivela kubaphathi bezomthetho emazweni amaningi, okuvumela ukufinyelela okusheshayo emakethe futhi kuqinisekise ukuthi izinto ezintsha zifinyelela iziguli ngokushesha. Labo abanesifiso sokuqonda ukuzinikela kweStellar Biotech kukhwalithi nokuhambisana nemithetho bangahlola i-Insizakalo iminikelo.

Ikusasa lobuchwepheshe be-membrane yefayibha eyimbobo ezindlini zokwelapha izinso lilindele intuthuko emangalisayo ehamba ngesayensi yezinto, i-nanotechnology, kanye ne-bioengineering. Ucwaningo olusafufusa lugxile ekuthuthukiseni ukungena kwe-membrane ngenkathi kuthuthukiswa kakhulu ukuhambisana nezinto eziphilayo ukunciphisa ukusabela komzimba ngesikhathi sokwelashwa nge-dialysis.

Ubuchwepheshe obusha njengokugqoka ama-membrane ngama-ejenti avimbela ukungcola nokuhlanganisa izinzwa ukuze kuqashwe ngesikhathi sangempela ukusebenza kahle kwe-dialysis kuyathandwa. Le nqubekela phambili ihlose ukwenza imigomo yokwelashwa ibe yomuntu siqu futhi ibe sezingeni eliphezulu, ngaleyo ndlela kuthuthukiswe ukuphepha kweziguli nemiphumela.

Ngaphezu kwalokho, ukugxila ekukhiqizeni okusimeme kanye namamoduli we-membrane angalahlwa kubonisa ukukhathazeka okukhulayo kwezemvelo emkhakheni wezempilo. Abaholi bemboni njengeStellar Biotech baqhubeka nokubambisana nabalingani be-R&D ukuletha lezi zizukulwane ezilandelayo ze-hollow fiber membranes emakethe, baqinisekisa ukuthi imikhuba yokwelapha izinso esindisa impilo ihlala isezingeni eliphezulu lobuchwepheshe.

Ukuhlala unolwazi ngentuthuko yabo yakamuva yenkampani kanye nemininingwane yemboni, vakashela i Izindaba Zenkampani ikhasi.

Ubuchwepheshe bemibhobho emincane (hollow fiber membrane technology) buyisisekelo esibalulekile ekwelashweni kwezinso zesimanje, bunikeza izinzuzo ezinkulu ekuhlanjululweni kwezinso (dialysis) ezigulini ezihlupheka ngokuhluleka kwezinso okungazelelwe (acute) nokungapheli (chronic). Amandla ayo aphezulu okuhlunga, ukuhambisana nomzimba (biocompatibility), nokwazi ukuzivumelanisa nezimo kwenze kube yingxenye ebalulekile emishinini yokunakekela izinso. Ukuzibophezela kweStellar Biotech Limited ekuhlinzekeni ngamamojuli emibhobho emincane (hollow fiber membrane modules) enesitifiketi se-GMP, enobuchwepheshe obusha, kuthuthukisa ukutholakala futhi kuqinisekisa ukunakekelwa kwezinga eliphezulu kweziguli emhlabeni wonke.

Njengoba ukuqhubeka okuqhubekayo kuqhubeka nokuqhakambisa ubuchwepheshe be-membrane, amathuba okuphathwa okuthuthukisiwe kanye nekhwalithi yokuphila kwesiguli amakhulu. Abahlinzeki bezempilo neziguli ngokufanayo bazuza emizamweni yokubambisana yezinkampani ezifana ne-Stellar Biotech, ezixhumanisa ubuchwepheshe nokuhambisana nokufinyeleleka komhlaba wonke. Ukuze uthole izixazululo eziphelele zezempilo nokusekelwa ekusebenziseni lezi zibuchwepheshe, hlola i-Stellar Biotech's Ukusekelwa izinsizakalo.

Ekugcineni, ukuthuthukiswa kwezimbotshana zangaphakathi ze-hollow fiber kugcizelela amandla okuguqula ubunjiniyela be-biomedical ekubhekaneni nezinselelo eziyinkimbinkimbi zezempilo, okunikeza ithemba nemiphumela engcono kwezigidi ezithintekayo isifo sezinso.