Monoclonal Antibodies, kubva kusainzi kusvika pakugadzira kugadzira ne TECNIC's Biotech Solutions

Muna 1986, iyo United States Food and Drug Administration (US FDA) yakabvumira yekutanga monoclonal antibody therapy, uye kubva ipapo, ndima yeinjiniya yekurwisa antibody yakave nekushanduka kukuru, sezvo monoclonal antibodies (mAbs) inomiririra kufambira mberi kwakakosha mubiotechnology uye kuita basa rakakosha mishonga yemazuva ano yekurapa. Chizvarwa chemazuva ano chemishonga inorwisa maantibody chinoratidza hunyanzvi hwepamusoro, zvichikonzera kudzikiswa kwakanyanya mumhedzisiro yakaipa. Nekuda kweizvozvo, masoja ekudzivirira chirwere akabuda sechikamu chikuru pakati pemishonga ichangogadzirwa yekurapa akasiyana ehutano hwevanhu, kusanganisira gomarara, autoimmune immune, metabolic mamiriro uye kutapukira.

Tichifunga nezvekukosha kwekushandisa kwemAb biotech, zvakakosha kukwiridzira ese ari maviri mhando uye huwandu hwekugadzirwa kwayo. TECNIC mhinduro, nekuzvipira kushanduka pamwe chete, inopa michina yakagadzirirwa kukubatsira iwe mukubudirira kwako monoclonal antibody. Our upstream bioreactors ⇀ dzakagadzirirwa kukwidziridza uye kukwenenzvera kugadzirwa kwemonoclonal antibody, kuve nechokwadi chekuwedzera goho. Uyezve, yedu Tangential Flow Filtration systems , yakagadzirirwa downstream kucheneswa, kupa nyore uye automatic nhanho yekuchenesa yaunoda mAb.

pasura TECNIC uye rega zvigadziriso zvedu zvigadzirise yako inotevera monoclonal mAb kubudirira.

Chii chinonzi monoclonal antibodies?

Monoclonal antibodies (mAbs) mapuroteni anogadzirwa murabhoritari anoita zvakafanana kune masoja ekudzivirira emuviri uye, naizvozvo, zvakagadzirirwa kuona, kusunga uye kuunza kusapindira kwekudzivirira kwekudzivirira kwezvirwere pavanenge vatarisana nemamwe mabhakitiriya, mavhairasi, fungi, tumor cell, allergens, uturu kana humwe muchetura. Aya masoja ekudzivirira chirwere anogadzirwa murabhoritari akagadzirwa kuti ave akanyatsojeka, uye maitiro awo anoita kuti akoshese mukuongororwa kwechirwere uye kurapwa.

Iyi monoclonal antibody kurapwa ndiyo muenzaniso wemushonga wemazuva ano, wakagadzirirwa kuve munhu uye zvichibva pane chaiwo hunhu hwechirwere. Kuve pamberi peakasarudzika marapirwo munzvimbo dzakaita sehematology, immunology, oncology uye chirwere chinotapukira uku uchidzikamisa yakashata systemic mhedzisiro ine chekuita nemaitiro echivanhu ekurapa.

Monoclonal antibody kurapwa inopa hutsanana hwepamusoro uye kunzwisisika kwakagadziridzwa nepo uchideredza mhedzisiro kana ichienzaniswa neyakajairwa therapeutics. Shanduko yekugadzirwa kwemonoclonal antibody, kubva ku hybridoma matekinoroji kuenda kumagetsi eDNA tekinoroji, haina kungowedzera kugona kwavo kwekurapa asiwo yakawedzera mashandisiro avo mukutsvaga nekuongorora mashandisirwo.

Kushandisa monoclonal antibodies

Monoclonal antibodies ma immunoglobulins anogara achishandiswa mundima dzinoverengeka, sezvo aine akati wandei anovimbisa anogona kurapa ekurapa mukurapa asima, autozvirwere zvinodzivirira zvirwere, kenza, chepfu, septicemia, kushandisa zvinodhaka, utachiona hwehutachiona, nezvimwe zvirwere. Zvakare, ivo vakave vakakosha kwete chete pakuongororwa kwehutano uye kutsvagisa, asiwo kudzivirira chepfu yechikafu uye kuongorora kusvibiswa kwezvakatipoteredza.

Mimwe mienzaniso yezvikumbiro inosanganisira:

Monoclonal antibodies mukurapa kenza uye tsvagiridzo

Kuongorora maitiro

Zvimwe zvikumbiro zvekurapa

Matambudziko mukugadzirwa kwemonoclonal antibodies

Sezvo yekutanga monoclonal antibody yakabvumidzwa muna 1986, antibody engineering yakashanduka zvinoshamisa. Sezvo kunzwisisa kwedu kwezvirwere kunowedzera, mukana wekurapa monoclonal antibody unowedzera. Takaona shanduko kubva mumurine kuenda kune masoja ekudzivirira chirwere muvanhu mune izvo zvave zvakabudirira kuedza kudzokorora zvakanyatsojeka maitiro emasoja ekudzivirira chirwere. Nekuda kwekufambira mberi uku, maantibody emazuva ano madhiragi ari kuwedzera kushomeka kwakashata nekuda kwekunyanya kukwirira kwawo, izvo zvakaita kuti mumakore achangopfuura vave boka guru remishonga mitsva yakagadzirwa.

Nekudaro, zvisinei nekubudirira uku kunoshamisa, kugadzirwa kwemonoclonal antibodies (mAbs) kuchiri kutarisana nemamwe matambudziko uye kuoma kunoda kuenderera mberi nekutsvagisa tekinoroji:

mAbs kutaura system

Zvibereko uye kunaka; scale-up complexities

Kukunda matambudziko ekuchenesa

Advanced Bioreactors

Kuti ibudirire bioprocess budiriro, kuchengetedza mutengo-kushanda, kuchengetedza inodiwa hunhu uku uchidzikisa nguva yekugadzira, uye nekupa kuchinjika kwekugadzira zvinhu zvakakosha mumusika wanhasi unokwikwidza maAbs. Zvakare, kuti ugadzire mahombe emasoja ekudzivirira chirwere mukati menguva yakareba, zvinodikanwa kukwenenzvera zvinhu zvakasiyana siyana, kusanganisira maseru, tsika midhiya, mamiriro etsika, uye kunyatsonzwisisa kwekuita kwetsika pazvikero zvakasiyana, kufambisa zvakanaka. chiyero-kumusoro uye danho rekuchenesa.

TECNIC Bioreactors ndiyo yekutanga mhinduro kune inoshanda uye yakasimba kugadzirwa kwemonoclonal antibodies. Yedu upstream bioreactors eLAB®, ePILOT® uye ePROD® dzakagadzirwa zvine hungwaru kuti dzipe kunyatso kudzora pamusoro pezvakatipoteredza paramita, optimize cellular mamiriro egoho rakakura uku ichideredza zviwanikwa uye nguva yekushandisa. Uku chaiko kutonga uye kuyerwa kwakaringana nechaiyo-nguva data kubva kune yedu automatic control unit PLC inoita kuti iwe ugone kukwenenzvera mamiriro etsika anodiwa kuti uwane kuberekana uye kunoenderana mhedzisiro. Sarudza maparamendi anodiwa - tembiricha, pH, kumhanya kwekukurumidza, gasi kuyerera, yakanyungudika O2 uye CO2, redox inogoneka, inogoneka sero kusungwa uye kushanda - uye gadzira yakatsetseka bioprocess kuita.

Pamusoro pezvo, kunyangwe maseru emammalian achiwanzoonekwa seakaoma kukwira nekuda kwekunzwa kwavo kune physico-kemikari mamiriro, TECNIC's inherent scalability uye kuchinjika kwemidziyo yedu inovimbisa yakabudirira chiyero-up maitiro ane automatic control system uye yakakodzera aeration uye agitation system. Kunyangwe iwe uri kuita tsvakiridzo yekupayona kana kutyaira maindasitiri-chikero kugadzirwa, tigonese kuti tisangane nemagumo ekuda kwako kwemhando yepamusoro monoclonal antibodies.

Tangential Flow Filtration midziyo ye monoclonal antibodies

Pakusvika padanho rekupedzisira reiyo bioreactor tsika, zvakakosha kuwana yakanaka mAb yekupedzisira-chigadzirwa. The advanced downstream Tangential Flow Filtration midziyo ye TECNIC zvinonyatsoparadzanisa antibody inotarirwa kubva kune tsvina uye tsvina, kuve nechokwadi chepamusoro chekuchena nepamusoro-soro yekuyerera. Uyezve, nekuda kwayo zvizere automatic system uye dzakasiyana-siyana dzesarudzo dzekushanda, eLAB® TFF ⇀, ePILOT® TFF ⇀ uye ePROD® TFF ⇀ batsira pakuchena kwekupedzisira kweiyo bioprocess yako yese nenhanho iri nyore.

TECNICMasisitimu eTFF akagadzirwa zvine hungwaru kuti asangane nezvinodiwa bioprocessing kudzoreredza chigadzirwa, zvichipa kucheneswa kwepamusoro pane akasiyana biotech application. Yedu yekusefa midziyo inogona kuzadzisa uye kuwedzera kugona kweako ese bioprocesses. Kupa mhinduro dzakavimbika dzekusefa, dzakasanganiswa nemazinga akakwira ekuyerera uye yakakwirira solute kuchengetwa, edu epamberi maficha anogadzirwa kuti anyatso. downstream kugadziriswa kwemAbs. Uyezve, yedu yepamusoro automatic masisitimu anopa mushandisi-ane hushamwari ruzivo pane akasiyana masikero ekushanda, kuve nechokwadi chisina musono uye chinowirirana mhedzisiro.

Kuedza kushoma mukuita sterility uye kuchenesa bioprocesses

TECNIC midziyo inogadzirwa kubva kusimbi isina tsvina AISI 304 uye 316L, saka mhinduro dzedu dzese dzakagadzirwa nemhando yepamusoro yemhando yepamusoro, zvichiunza chibereko chisingaenzaniswi pamarabhoritari uye zviyero zveindasitiri. Pamusoro pezvo, tichinzwisisa kuti indasitiri yega yega ine yakasarudzika yekuchenesa zvinodiwa, isu tinogadzirawo sarudzo zvizere automatic uye Nyore-kushandisa ePLUS® CIP system ⇀, inova innovative compact solution inoratidzira prestablished recipes uye huwandu hukuru hwesarudzo dzinogoneka kuti usangane nezvinodiwa mu bioprocessing zvivakwa. Inokwanisa kubata mabasa ekuchenesa emidziyo mavhoriyamu anosvika 2000 malita, iyo ePLUS® CIP inogonesa kuenderana, kwemhando yepamusoro mhedzisiro ine intuitive configuration ruzivo, kuwedzera kushanda zvakanaka uye kuderedza kuderera kwezvivakwa zvakakura zvebioprocessing.

Nekudaro, vamwe vatengi vanosarudza kushandiswa kweKamwe-Shandisa bioreactors, sezvo ivo vachibvumira kuti ive nyore bioprocess kusimbiswa uye inoda kushoma kuedza nezve sterility uye kuchenesa. Nechikonzero ichi, mune inokurumidza kushanduka mamiriro eBiotech, iyo itsva Kumwe-Kushandisa eBAG® of TECNIC ⇀ inokwidziridza yako bioprocess kuedza neyakatsanangurwa mashandiro, chimiro, kusimba uye nyore. Yakagadzirwa uye yakagadzirwa mukati TECNIC ISO7 Kamuri Yakachena (End-to-End methodology) uye yakavakwa nezvinhu zvakaoma, zvemhando yepamusoro, zvigadzirwa izvi zvinosangana negamma irradiation, izvo zvinovaita kuti vagadzirire-kushandisa zvinoenderana neyakaomesesa indasitiri yemishonga zviyero.

Inowanikwa muhukuru hwakasiyana, inogona kuunzwa nekukurumidza murabhoritari uye yekugadzira zvivakwa sezvo kuisirwa, hunhu uye kudzidziswa kwevashandi zvinodiwa zvishoma. Mukuwedzera, SU eBAG® inogona kuwedzera simba rekudyara uye kuchinjika nekudzikisa nguva yekutendeuka, kunyanya kana paine kusvibiswa, uye kudzikira nguva yekumisikidza. Kuita dhizaini shanduko zvakare nekukurumidza nekurasa SU eBAG®, kubvumira kuenderera mberi kwekuvandudzwa uye kubatanidzwa kwehunyanzvi hutsva hwakadai senge pa-line monitoring system. Pakazere, aya mabhenefiti anotungamira kune yakadzikira mutengo wemari uye yakaderera zviwanikwa zvinodiwa, zvinova zvakakosha zvemakambani makuru nemadiki zvakafanana.

Nyaya dzekubudirira uye maapplication

Kunyange isu tisingakwanise kupa ruzivo rwakakwana nekuda kwekuvanzika, kwave kune dzakawanda zviitiko apo TECNICMidziyo yemidziyo yakawedzera zvakanyanya kugadzirwa kwemonoclonal antibodies. Vatengi vedu vakaisa chivimbo chavo matiri, uye kubudirira kwe TECNIC mhinduro dzinosimbisa kunaka kwedu uye kuzvipira kushanduka pamwe chete.

Semuenzaniso, munharaunda yekufambira mberi kutsva mukuongororwa kwevarwere, mumwe wevatengi vedu ane chinangwa chekubvumidza zvipatara gadzira sampuli dzeropa remurwere pamwe nekubatanidzwa kwekuyerera kwe cytometry kuongorora uye monoclonal antibodies. Kune yavo in vitro diagnostics, vaifanira Kuwedzera kugadzirwa kweimwe yebudiriro yavo yekutsvagisa (vachishandisa eLAB® Advanced ⇀ se bioreactor). Sezvo vaishuvira kugadzira huwandu hwakakura hweiyo inodiwa recombinant IgM, vakatenga imwe ePILOT® BR ⇀ uye mumwe ePILOT® TFF, kuvimba TECNIC yakasimbiswa zviyero zvemhando uye kusimba kweiyo bioprocess.

Kusvetuka TECNIC biotech mhinduro, vakakwanisa kukwidziridza sisitimu yekutaura yemasero avo, zvichitungamira kune goho repamusoro remaAbs. Pashure, kushandisa ePILOT® TFF, mutengi uyu akakwanisa kuchenesa maAbs aidiwa echigadzirwa chavo chekuongorora. Nekuda kweizvozvo, zvibodzwa zvavo zvekugadzira zvakazadzikiswa nekuwedzera kushanda nesimba uye yakakwana mhando yekupedzisira-chigadzirwa. Zvakare, kuzvipira kwedu kumapurojekiti evatengi vedu kunovimbisa kuti isu tinogara tichigadziridzwa pane chero zvigadziriso kana rumwe rubatsiro rungangodiwa, uye parizvino, isu tichiri kupa rubatsiro runoenderera uye kuramba takabatikana nechirongwa ichi chevatengi.

Muchikamu chemishonga, TECNIC anoshandiswa shandira pamwe nemakambani akatarisana nekugadzirwa kwakakura kwezvigadzirwa zvebiotech pharma senge monoclonal antibodies, anticancer drugs, cell therapies, nezvimwe. Izvi zvekucheka-kumucheto zvemishonga uye biotechnology zvigadzirwa zvinowanzoda kushandiswa kwebioreactors kwe upstream process uye downstream tangential filtration systems kuti ive nechokwadi chegoho rakakwana, kuchena, uye scalability. 

Semuyenzaniso, TECNIC parizvino ari kubatanidzwa zvakanyanya mu a veterinarian yakakura-yekugadzira chirongwa cheChlamydia chekuongorora hutachiona. Mune iyi biotech kuyedza, yedu ePROD® midziyo inoita basa rakakosha, ichipa iyo chaiyo uye kutonga kwakaringana kweiyo bioprocess kuona goho repamusoro remamAbs rinotarisirwa purojekiti iyi. Zvadaro, yedu ePROD® TFF zvinonyatso paradzanisa chinangwa chemonoclonal antibody kubva kune vezvenhau tsika uye kumwe kusvibiswa. Izvi zvinopera nehuwandu hwepamusoro hwekuchena hwakasanganiswa nemitengo yegoho inokatyamadza, chinova chiratidzo chekuzvipira kwedu mukubudirira kwevatengi.

Ongorora huwandu hwedu hwakakwana hwemidziyo

Yedu bioreactors yakagadzirirwa kushandiswa kwakasiyana, kuve nechokwadi chekushanda uye kunaka. Tsvaga yedu yakazara yakazara biotechnology mhinduro, kusanganisira Bioreactors, Tangential Flow Filtration masisitimu, nezvimwe. Shanyira mapeji edu e Bioreactors ⇀, Tangential Flow Sefa ⇀, uye Contact ⇀ kuti uwedzere information uye kubvunza.