Kawm Txog Cov Txheej Txheem Ua Haujlwm Ntawm Ultrafiltration Membrane Cassette hauv Biopharmaceutical Field (Part 1)
Txheej Txheem Txheej Txheem (PC) feem ntau yog kawm txog kev cuam tshuam ntawm cov txheej txheem tawm tswv yim ntawm cov txheej txheem tso tawm, thiab kev tswj ntau yam ntawm cov txheej txheem tsis tuaj yeem txiav txim siab los ntawm kev kawm, uas yuav txhim kho cov txheej txheem kev ruaj ntseg, txo cov khoom sib txawv thiab txo qhov kev pheej hmoo ntawm kev ua tsis tiav. Xyuas kom meej tias cov txheej txheem Performance validation batches (PPQ) thiab cov khoom lag luam ua lag luam ib txwm tsim cov khoom uas ua tau raws li cov qauv zoo.
Lub hom phiaj tshwj xeeb
Txheeb xyuas cov txheej txheem tsis zoo uas cuam tshuam rau cov khoom lag luam zoo thiab cov txiaj ntsig: Cov txheej txheem tus yam ntxwv tso cai rau koj los txiav txim siab cov txheej txheem twg muaj feem cuam tshuam rau cov khoom lag luam tus yam ntxwv tseem ceeb (CQA).
Txiav txim siab qhov ntau yam ntawm kev ua haujlwm tsis zoo thiab cov qauv siv tau: qhov no suav nrog kev txiav txim siab txog kev tswj hwm ntawm cov txheej txheem tsis ua haujlwm kom ntseeg tau tias cov khoom tsim ua tau raws li cov qauv kev cai ua ntej.
Txiav txim siab qhov kev sib raug zoo ntawm cov txheej txheem tsis thiab qhov tseem ceeb tsis zoo: Los ntawm kev txheeb xyuas cov kev sib raug zoo ntawm cov txheej txheem tsis thiab qhov tseem ceeb tsis zoo, cov txheej txheem ntws tuaj yeem ua kom zoo thiab cov khoom zoo tuaj yeem txhim kho.
Raws li ntau thiab ntau cov tshuaj biopharmaceuticals nkag mus rau theem ntawm kev tshawb fawb soj ntsuam / sau npe kho mob tseem ceeb, Cov Txheej Txheem Txheej Txheem, Kev Ua Haujlwm Zoo (PV) ua haujlwm maj mam muab tso rau hauv cov txheej txheem. Cov txheej txheem tus cwj pwm thiab cov txheej txheem validation raws li QbD lub tswv yim yog ib qho ntawm cov haujlwm tseem ceeb tshaj plaws hauv kev tshawb fawb tshuaj premarket.
Cov txheej txheem Ultrafiltration tau dhau los ua cov txheej txheem tseem ceeb hauv cov txheej txheem biopharmaceutical ntau lawm, thiab daim nyias nyias nyias nyias tau dhau los ua cov khoom siv tseem ceeb hauv biopharmaceutical ntau lawm. Txoj kev kawm txog cov txheej txheem ntawm cov txheej txheem ntawm ultrafiltration membrane cassettes nyob rau hauv daim teb ntawm biopharmaceutical daim ntaub ntawv yog undoubtedly tseem ceeb heev, thiab nws muaj feem xyuam rau cov tseem ceeb cov kev txaus siab thiab kev loj hlob mus sij hawm ntev ntawm cov khoom. Lub hom phiaj ntawm ultrafiltration membrane cassette txoj kev kawm characterization yog los kawm txog kev cuam tshuam ntawm ultrafiltration txheej txheem kev khiav hauj lwm tsis ntawm cov txheej txheem kev ua tau zoo / cov khoom zoo, txhawm rau txiav txim siab cov txheej txheem tseem ceeb thiab lawv cov ntsiab lus teeb tsa thiab qhov kev lees paub. Membrane cassette yog ib qho tseem ceeb ntawm daim nyias nyias ntawm tangential flow ultrafiltration system. Cov txheej txheem tsim khoom ntawm tangential flow ultrafiltration yog txiav txim los ntawm ntau qhov tsis muaj, ntawm cov txheej txheem tseem ceeb yog: kev xaiv cov khoom siv membrane, xaiv cov membrane pore loj, tangential flow control, zoo TMP tswj, load pov thawj, membrane cheeb tsam xaiv, system tu, membrane lub neej. kev txheeb xyuas, kev lim ntshav kom zoo, thiab lwm yam. Cov kev txwv no tsis yog cuam tshuam rau ib leeg xwb tab sis kuj txwv ib leeg. Txhawm rau ua tiav lub hom phiaj ntawm kev txhim kho cov txheej txheem kev ruaj ntseg thiab kev ua haujlwm ntau lawm nyob rau tib lub sijhawm, nws yog qhov yuav tsum tau ua kom zoo dua cov kev txwv no ua ntej. Hauv qab no peb luv luv qhia cov tswv yim optimization ntawm ntau yam txheej txheem tseem ceeb.
Kev xaiv cov khoom membrane
Cov ntaub ntawv ntawm ultrafiltration membrane cassette yog polyether sulfone (PES), regenerated cellulose (RC), polyvinylidene fluoride (PVDF) thiab hais txog.
Polyether sulfone (PES)
PES yog cov khoom siv ultrafiltration feem ntau siv tam sim no. PES muaj qhov muaj zog hydrophobicity lossis lipophilicity, yog li nws muaj dej ntws tsawg thiab muaj peev xwm tiv thaiv tsis zoo. Yog li, feem ntau PES daim nyias nyias ntawm kev ua lag luam yog hloov kho hydrophilic polyether sulfone (PESU). PESU membrane yog tus cwj pwm los ntawm kev kub siab, kua qaub thiab alkali tsis kam, siab tsis kam, kub tsis kam thiab oxidation tsis kam. Nws yog tsuas yog siv nyob rau hauv high-concentration protein daws (xws li monoclonal antibody, HSA, IgG, recombinant protein, thiab lwm yam), cell harvesting, tshuaj tiv thaiv, tshuaj tua kab mob, contrast agents, tsoos suav tshuaj, tshuaj hluavtaws, thiab lwm yam.
Regenerated cellulose (RC)
Piv nrog rau lwm cov ntaub ntawv, qhov zoo tshaj plaws ntawm RC yog qhov tsis tshua muaj protein ntau adsorption. Tsis tas li ntawd, cellulose yog sib xws nrog cov kuab tshuaj organic ntau dua li polyether sulfone, tab sis nws tsis tuaj yeem ntxuav thiab khaws cia nrog cov ntsiab lus siab ntawm NaOH. RC daim nyias nyias yog tsuas yog siv nyob rau hauv uas tsis muaj concentration protein tov, cov protein yield muaj siab xav tau thiab cov tshuaj muaj organic solvents, tab sis tsis yog tag nrho cov organic solvents yuav ultrafilted nrog cellulose membrane, nws yog tsim nyog los xaiv tiv thaiv compatibility ntawm daim nyias nyias.
Polyvinylidene fluoride (PVDF)
PVDF yog cov khoom siv tshwj xeeb polymer nrog kev ruaj ntseg zoo heev, thermal stability thiab huab cua tsis kam, thiab muaj zog txhua yam thiab compressive kuj. Cov membrane no muaj qhov permeability siab thiab tsis tshua muaj peev xwm thaiv, tuaj yeem hloov cov molecules me me thiab dej, thaum thaiv cov molecules loj thiab cov khoom siv. Hauv kev lag luam biomedicine, PVDF daim nyias nyias tuaj yeem siv rau kev npaj cov protein purified, cell kab lis kev cai, kev sib cais ntawm cov ntshav, thiab lwm yam. Txawm hais tias PVDF ultrafiltration membrane muaj kev ua tau zoo, nws feem ntau siv rau hauv cov txheej txheem microfiltration.
Membrane aperture xaiv
Ultrafiltration pore loj yog ib qho tseem ceeb ntawm kev ua tau zoo indexes ntawm ultrafiltration membrane, uas ncaj qha cuam tshuam rau kev sib cais efficiency thiab flux ntawm daim nyias nyias. Lub aperture loj dhau ua rau cov nyhuv pom tsis zoo thiab tsis tuaj yeem tshem tawm impurities zoo; Lub aperture me me dhau lawm yuav txo qhov pom kev nrawm, thiab txawm tias ua rau txhaws, cuam tshuam rau kev pabcuam lub neej ntawm ultrafiltration membrane. cov
Kev xaiv ntawm daim nyias nyias pore loj yog feem ntau 3-6 lub sij hawm ntawm qhov hnyav molecular ntawm lub hom phiaj cov khoom, nyiam dua 5 zaug, thiab siab txaus tus nqi yog ua tiav thaum ua kom muaj kev rov zoo siab. Cov lus hauv qab no qhia tau hais tias feem ntau siv apertures ntawm membrane cassette hauv qee qhov kev thov scenarios.
Tangential flow tswj
Tangential Flow yog qhov nrawm ntawm cov kua dej dhau los thiab sib npaug mus rau saum npoo ntawm daim nyias nyias, feem ntau qhia hauv litres ib feeb (L / min) lossis litres ib square meter ib teev (L / ㎡ / h). Tangential flow plays lub luag haujlwm tseem ceeb hauv tangential flow ultrafiltration, uas txiav txim siab hom ntws ntawm cov kua hauv daim nyias nyias, yog li cuam tshuam rau kev pom kev ua haujlwm thiab kev pabcuam lub neej ntawm daim nyias nyias. Tangential ndlwg muaj "ntxuav" cuam tshuam rau saum npoo ntawm lub lim membrane, thiab tsim nyog ua kom cov tangential txaus tus nqi pab txo cov concentration polarization thiab nce Flux. Txawm li cas los xij, siab dhau tangential ntws kuj tseem yuav ua rau lub zog shear raug rau cov khoom, uas tuaj yeem ua rau txo qis hauv cov khoom lag luam. Yog li ntawd, kev xaiv qhov tsim nyog tangential txaus tus nqi yuav tsum tau xav txog qhov kam rau ntawm tus qauv thiab cov kev cai ntawm cov txheej txheem filtration.
Tus tangential txaus tus nqi yog nyob ntawm qhov loj ntawm lub membrane cassette qauv thiab cov tshuaj ntsuam hom xaiv. Cov neeg muag khoom sib txawv yuav pom zoo sib txawv tangential txaus tus nqi raws li cov yam ntxwv ntawm lawv tus kheej daim nyias nyias. Lub tangential txaus tus nqi pom zoo los ntawm Guidling ultrafiltration membrane yog 4-6L / m² / min, tab sis rau qee cov qauv rhiab, nws tuaj yeem tsim nyog qis dua qhov pom zoo raws li qhov xwm txheej tiag tiag.
Siv tau zoo transmembrane siab (TMP) tswj
TMP yog ib qho tseem ceeb parameter hauv tangential flow ultrafiltration txheej txheem. Zoo transmembrane siab (TMP, unit: bar lossis psi) yog hais txog qhov nruab nrab siab sib txawv ntawm ob sab ntawm daim nyias nyias. Flux (L / m² / h, L / m² / h, LMH) yog tus nqi ntawm cov kua uas dhau los ntawm daim nyias nyias ntawm ib chav tsev ib lub sijhawm rau ib chav tsev membrane. Hauv tangential flow ultrafiltration txheej txheem, TMP yog ze ze rau Flux.
Hauv cov txheej txheem tangential flow ultrafiltration tas li, kev sib raug zoo ntawm Flux thiab TMP tuaj yeem muab faib ua ob theem.
TMP= (Pin + Pout) /2-Pp (Pin= pub siab, Pout= rov siab, Pp= kis siab).
Kev kub siab ntsig txog cheeb tsam: Thaum xub thawj, Flux tsuas yog cuam tshuam los ntawm kev ua haujlwm ntawm lub lim membrane, yog li Flux yuav nce linearly thaum TMP nce.
Siab ywj siab cheeb tsam los yog gel txheej tswj cheeb tsam: Nrog rau tas mus li nce ntawm TMP, lub lim membrane yog maj polarized los ntawm concentration, thiab ib feem ntawm lub TMP nce yog offset los ntawm cov tsis kam ntawm cov concentration polarization txheej, yog li qhov nce hauv Flux maj mam qeeb. . Txog thaum kawg, lub lim membrane yog kiag li polarized los ntawm concentration, thiab cov TMP nce yog kiag li offset los ntawm cov tsis kam ntawm concentration polarized txheej. Lub sijhawm no, Flux tsis nce ntxiv lawm.
Nyob rau hauv cov txheej txheem optimization ntawm tangential flow TMP, Flux Flux thiab TMP yog npaj los nrhiav qhov inflection point ntawm TMP (flux tsis hloov nrog qhov nce ntawm TMP), thiab 70-80% ntawm tus nqi ntawm inflection. taw tes ntawm TMP feem ntau yog coj los ua qhov zoo tshaj plaws TMP point. Lub sij hawm no, lub lim membrane tsis tau tag nrho polarized los ntawm concentration, thiab tus nqi flux kuj siab.
Thauj khoom pov thawj
Peev xwm (L / m² lossis g / m²) yog hais txog qhov ntim lossis qhov loj ntawm cov kua lim ib square meter ntawm thaj chaw membrane. Qhov no yog ib qho ntawm cov cim tseem ceeb tshaj los ntsuas kev ua haujlwm pom. Lub load ntawm cov kua sib txawv txawv heev, txawm tias tib cov kua (xws li cov tshuaj tiv thaiv) yog siv, vim yog cov txheej txheem sib txawv ntawm ntau lub tuam txhab, cov kev xaiv lim thiab thauj khoom thiab lwm yam kev ntsuas kev ua haujlwm tsis zoo ib yam.
Cov hauv qab no yog qhov pom zoo muaj peev xwm ntawm Guidling ultrafiltration membrane cassettes rau thaj chaw sib txawv.
Ua ntej cov txheej txheem txiav txim siab, kev tshawb fawb thiab kev txhim kho kev sim yuav tsum tau ua, thiab {{0}}.11m² lossis 0.5m² membrane cassettes feem ntau yog siv rau hauv kev tshawb fawb thiab kev loj hlob theem. Kev sim thawj zaug siv 1{{10}}kd 0.11m² membrane cassette rau 45min los ua 2L kua ua piv txwv, txhawm rau txiav txim siab txog qhov load ntawm 10kd 0.11㎡ membrane cassette, lub lub sijhawm txheej txheem tau txiav txim siab thawj zaug, thiab lub sijhawm ua haujlwm ntawm 4L, 5L thiab 6L raug kaw raws li qhov ntsuas siab ntawm TMP < 1.0bar kom txog rau thaum lub sijhawm txheej txheem tau mus txog. Nyob rau lub sijhawm no, qhov sib xyaw ua haujlwm muaj peev xwm yog qhov siab tshaj plaws ntawm 10kd 0.11m² membrane cassette hauv lub sijhawm kwv yees. Nyob rau hauv qhov tseeb ntau lawm, proportional amplification yuav ua tau.
Yog tias koj xav paub ntau ntxiv txog kev thauj khoom ntawm Guidling ultrafiltration membrane cassettes, koj tuaj yeem tiv tauj peb rau kev sib tham tob ntxiv.
Hais txog Guidling
Guidling Technology yog lub teb chaws high-tech enterprise tsom rau biopharmaceuticals, cell culture, purification thiab concentration ntawm biomedicine, kuaj mob thiab muaj kua. Peb tau ua tiav cov khoom siv lim dej centrifugal, ultrafiltration & microfiltration cassettes, cov kab mob lim, TFF system, qhov tob lim, hollow fiber, thiab lwm yam. Uas tau raws li daim ntawv thov scenarios ntawm biopharmaceuticals, kab lis kev cai ntawm tes, thiab lwm yam. Peb cov membranes thiab cov lim dej lim tau dav siv hauv kev sib xyaw, kev rho tawm thiab kev sib cais ntawm kev pom ua ntej, microfiltration, ultrafiltration thiab nanofiltration. Peb cov kab ntau cov khoom, los ntawm me me, ib leeg-siv chav kuaj pom mus rau ntau lawm filtration systems, sterility kuaj, fermentation, cell kab lis kev cai thiab lwm yam, ua tau raws li cov kev xav tau ntawm kev sim thiab ntau lawm. Guidling Technology tab tom tos ntsoov rau kev koom tes nrog koj!