TECNICYankho lakusintha ma cell Therapy

M'mawonekedwe a biotechnology, kupita patsogolo kwakukulu kukuchitika m'mibadwo yotsatira ma cell and gene therapy (CGTs) ⇀, kuwonetsa njira yoyambira njira zochiritsira zomwe sizinachitikepo mwa odwala omwe ali ndi njira zochepetsera zochizira pazochitika zapadera zachipatala popereka njira zaumwini komanso zolunjika

Tekinoloje yatsopanoyi, yotchedwa cell therapy, imayang'ana kwambiri kubweretsa maselo atsopano athanzi m'thupi ndi cholinga kusintha odwala kapena owonongeka, kusintha magwiridwe antchito a maselo a wodwalayo kudzera muzinthu, kapena encompasskuchotsedwa kwa maselo osagwira ntchito pogwiritsa ntchito maselo oteteza thupi. Kuthekera kwa chithandizo cha ma cell kuyimitsa ndi kubweza matenda, kubwezeretsanso ziwalo zowonongeka, ndikuchiritsa matenda omwe aika moyo pachiwopsezo tsopano ndi cholinga chenicheni cha asayansi omwe amagwira ntchito patsogolo pamankhwala obwezeretsanso. Komabe, pali zovuta zaposachedwa komanso zanthawi yayitali zomwe zitha kukhala zovuta panthawi yopanga njira zochizira zamankhwala izi.

Poyankha, TECNIC upstream scalable cell expansion bioreactors ndi downstream kukonza matekinoloje kumagwira ntchito yofunika kwambiri pothandizira kukula kwa ma cell, kukolola, kutsuka, ndi kukhazikika, kukuthandizani nthawi zonse kukwaniritsa zomwe mukufuna kuchokera. masikelo a Clinical Research to Pilot and Industrial Bioprocesses ⇀.

Kodi ma cell therapy ndi chiyani?

Kuchokera pamalingaliro a chitukuko cha moyo, matenda m'thupi lamoyo nthawi zambiri amawonetsa zovuta mu gawo loyambira la moyo wake: maselo. M'lingaliro limeneli, chithandizo cha ma cell ndi liwu lalikulu lomwe limakhalapopasses ndi kugwiritsa ntchito ndi kusiyanitsa mitundu yosiyanasiyana ya ma cell, nthawi zambiri ma cell amphamvu, ngati ntchito yochizira zomwe zimapereka zotsatira zodabwitsa kwa odwala omwe akusowa njira zatsopano zothandizira. Cholinga chachikulu cha mtundu uwu wa biotherapy ndikupanga mankhwala ndi njira zochizira kukonza ndi kulimbikitsa minofu ndi ziwalo zowonongeka kapenanso, kuchiza matenda ndi mikhalidwe monga matenda a m'mapapo, matenda a neurodegenerative, automatenda a chitetezo cha mthupi ndi khansa monga achikulire-oyamba khansa ya m'magazi, Hodgkin's lymphoma, kapena acute myeloblastic leukemia (AML)

Chitsanzo chabwino pakugwiritsa ntchito kwake ndikugwiritsa ntchito ma cell opangidwa ndi pluripotent stem cell (maselo a iPSC) kuti apereke gwero la ma cell opanda malire a CAR T cell therapy, zomwe zimaphatikizapo kukonzanso ma T-maselo a wodwala kuti awone ndikuwononga ma antigen enieni a khansa. Kuphatikizika kwa matekinoloje a iPSC ndi CAR kumapereka mwayi wodabwitsa ku oncology ndikufulumizitsa kwambiri chitukuko cha ma cell-based therapy kwa odwala khansa.

Ubwino wa biotherapy iyi ndikuti ukhoza kukhala mwakukonda kuchiza ma pathologies enieni. Komanso, kutsatira principle "Primum non nocere" (poyamba musavulaze) ndikuganiziranso kuti kukonza ma cell kumachitika mwachilengedwe m'thupi la munthu, chithandizo cham'manja chimaonedwa kuti ndi chotetezeka, popanda zotsatirapo kapena zochepa zomwe zimawonedwa m'maphunziro ambiri azachipatala komanso azachipatala. .

Kuchiza kwa ma cell komanso kusintha kwamankhwala amunthu payekha

Mankhwala apangidwe ndi njira yatsopano yopewera matenda ndi chithandizo chomwe chimaganizira kusiyana kwa momwe anthu amachitira ndi mankhwala kuti apereke "mankhwala oyenera pa mlingo woyenera pa nthawi yoyenera". Pambuyo povomerezedwa m'mayesero azachipatala, kupita patsogolo komwe kwachitika muzamankhwala osankhidwa payekha kwapangitsa kale kupezedwa kwamphamvu kwatsopano ndi chithandizo chovomerezeka chomwe chimagwirizana ndi mikhalidwe yamunthu payekha.

Mkati mwa paradigm iyi, allogenic ndi automankhwala ochizira ma cell zimawoneka ngati njira zodalirika:

Autologous cell therapy

Allogenic cell therapy

Scale-up vs Scale-out njira

Mavuto mu cell therapy

Thandizo la ma cell likupangidwa mwachangu ndipo ali ndi chiyembekezo chachikulu chochiza matenda ambiri. Komabe, pali zovuta zanthawi yayitali komanso zazitali zomwe zimayenera kuthana nazo zomwe zimapangitsa kuti pakhale zopinga pakupanga mankhwalawa:

Zovuta kupanga

Zovuta za scalability

Mtengo wa zovuta zopanga

Advanced Bioreactors

Poyankha mavutowa, TECNIC zachitika autozida za matic bioprocess kwa onse awiri upstream ndi downstream Chitukuko. Timamvetsetsa kuti, mosiyana ndi kupanga kwachikhalidwe chaukadaulo (monga mamAbs ndi ma biologics ena), kupanga ndi kukonza kwamankhwalawa kumafuna kuti zinthu zam'manja zizikhalabe ndi mikhalidwe yofunikira (CQAs) yomwe idaganiza zonse.

Pachifukwachi, TECNIC eLAB® ⇀ , ePILOT® ⇀ ndi ePROD® ⇀ ma bioreactors adapangidwa kuti awonetsetse kuti ali ndi zotsatira zapamwamba komanso zotha kupanganso kuti athe kuthana ndi zovuta zomwe tazitchula kale. Timapereka yankho labwino kwambiri la bioprocess pamachiritso a ma cell, monga zida zathu zidapangidwa mwaluso kuti zizitha kuyang'anira zowongolera zachilengedwe, kukhathamiritsa ma cell kuti apeze zokolola zambiri ndikuchepetsa chuma ndikugwiritsa ntchito nthawi. Kuphatikiza apo, zida zathu zidapangidwa ndi automatic unit control yomwe imaphatikizapo machitidwe ophatikizika a data analytics, omwe amakupatsani mwayi wokonza bwino chikhalidwe kuti mupange magwiridwe antchito osavuta a bioprocess.

Advanced Bioreactor Solutions ⇀

Tangential Flow Filtration mu cell therapy

Ambiri mwa kafukufuku ndi chitukuko cha bioprocesses of cell and gene therapies (CGTs) ayang'ana kwambiri pakukula kwa upstream ndondomeko. Ngakhale R&D iyenera kupitiliza kuyang'ana kwambiri pakukweza kachulukidwe ka cell ndi zosowa zina zakukulitsa ma cell, zopinga zopanga zikutsamira ku downstream kukonza. Kuti tikwaniritse chosowachi mokhazikika kwambiri komanso kutulutsa kwakukulu, athu eLAB® TFF ⇀, eLAB® TFF SU ⇀, ePILOT® TFF ⇀ ndi ePROD® TFF ⇀ perekani yankho lomwe lingakhale wamba, autowokwanira, wokhazikika komanso wodalirika kukonza ntchito zachitukuko. Kaya mukuchita upainiya kapena mukuyendetsa ntchito yopanga mafakitale, tithandizireni kukwaniritsa zomwe mukufuna kuti mupange mapulojekiti anu azachipatala.

Kuonetsetsa kuti zikupita patsogolo upstream processing akuchulukitsidwa, TECNIC zida komanso amaonetsetsa ogwira downstream kukulitsa njira yochepetsera voliyumu, kutsuka ndi kupanga chomaliza. Pa nthawi yomweyo, a autokukonza zida zathucipes imachepetsa kwambiri kufunika kosintha pamanja, kulimbikitsa magwiridwe antchito ndi kuchepetsa mtengo wantchito. Kuphatikiza apo, timakuthandizani kuti mukhale ndi chilolezo chokhala ndi mapuloteni ambiri, kuchira kwambiri kwa ma cell omwe amatha kukhala ndi mphamvu zochepa pakuchita kwake.

Njira Zapamwamba Zosefera za Tangential Flow ⇀

Nkhani zopambana ndi kugwiritsa ntchito

Poganizira zovuta za bioprocess, sizodabwitsa mtengo wodziwika bwino wamankhwalawa. Mu TECNIC tikufuna kuthandiza makasitomala athu kupanga cell mankhwala scalable, choncho, mosavuta kwa odwala. Monga ukadaulo wina uliwonse, mtengo wake umatsika pakapita nthawi ndi luso labwino kwambiri, ndipo, ngakhale sitingathe kupereka mwatsatanetsatane chifukwa chachinsinsi, pakhala pali zochitika zambiri pomwe TECNICZida zathandizira kwambiri kupanga mankhwalawa.

Ndi athu kwathunthu automatic bioreactor eLAB® Advanced komanso chifukwa cha kasinthidwe kake kambiri (mpaka zombo 12 zodziyimira pawokha), m'modzi mwamakasitomala athu akupanga chitukuko chodabwitsa kwambiri. autologous cell therapy m'malo mwa mafupa owonongeka pambuyo pochiza khansa yokongoletsa. Podziwa kuti, monga momwe zimakhalira ndi mtundu uliwonse wa chithandizo cha ma cell, kuchuluka kwa mankhwala omaliza komanso kuchuluka kwake kumadalira kuchuluka kwa ma T cell omwe adayatsidwa ndikukulitsidwa kwa ex vivo, kasitomala uyu anali ndi zofunika ziwiri zofunika:

Chifukwa chosowa chofunikira chogwirizana, maselo a T odwala onse adatsegulidwa kuti ayambitse kukula kwa ex vivo komwe kumafunikira chikhalidwe chapadera cha bioreactor.

Komanso, chifukwa wodwala wawo nthawi zambiri amadwala kwambiri, ma T cell awo amakhala okhwima, amasiyanitsidwa ndipo mwina amakula mopanda pake, kotero kasitomala wathu amafunikira kukulitsa selo mumikhalidwe okhwima kwambiri chikhalidwe.

Kuti tikwaniritse mfundo ziwirizi, tidalimbikitsa kasitomala wathu eLAB® Advanced ⇀. Chifukwa cha zida izi, zomwe zidapangidwa mosiyanasiyana m'malingaliro, bioreactor yathu idawapatsa mphamvu kuti azikula bwino kwambiri ndikuwongolera zikhalidwe zosiyanasiyana za T cell za odwala awo, zomwe zimawathandiza kusintha chikhalidwe chawo pogwiritsa ntchito automatic control unit yoyendetsedwa ndi Industrial PLC. Ndi izo, adatha kukhala ndi mphamvu zonse pazigawo zofunika - monga kutentha, pH, mpweya wosungunuka, ndi liwiro lachisokonezo - mpaka 12 zikhalidwe zodziimira payekha panthawi imodzi ndi kudalirika komanso kuchita bwino.

Makasitomala yemweyo, powona zotsatira zabwino zam'mbuyomu ndi TECNIC zida ndi chithandizo, adaganiza zokulitsa imodzi mwa mizere yawo yapitayi yogwiritsira ntchito mankhwala a allogenic, omwe anapangidwa m'magulu akuluakulu kuchokera kumagulu operekera osagwirizana monga mafupa. Pofuna kuti chithandizo cha allogenic cell chifikire kwa odwala, maphunziro awo a kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kabwino kake autokupanga mamatic mu zikhalidwe za 50 L.

 

Poganizira zovuta za bioprocess, sizodabwitsa mtengo wodziwika bwino wamankhwalawa. Mu TECNIC tikufuna kuthandiza makasitomala athu kupanga cell mankhwala scalable, choncho, mosavuta kwa odwala. Monga ukadaulo wina uliwonse, mtengo wake umatsika pakapita nthawi ndi luso labwino kwambiri, ndipo, ngakhale sitingathe kupereka mwatsatanetsatane chifukwa chachinsinsi, pakhala pali zochitika zambiri pomwe TECNICZida zathandizira kwambiri kupanga mankhwalawa.

Ndi athu kwathunthu automatic bioreactor eLAB® Advanced komanso chifukwa cha kasinthidwe kake kambiri (mpaka zombo 12 zodziyimira pawokha), m'modzi mwamakasitomala athu akupanga chitukuko chodabwitsa kwambiri. autologous cell therapy m'malo mwa mafupa owonongeka pambuyo pochiza khansa yokongoletsa. Podziwa kuti, monga momwe zimakhalira ndi mtundu uliwonse wa chithandizo cha ma cell, kuchuluka kwa mankhwala omaliza komanso kuchuluka kwake kumadalira kuchuluka kwa ma T cell omwe adayatsidwa ndikukulitsidwa kwa ex vivo, kasitomala uyu anali ndi zofunika ziwiri zofunika:

  • Chifukwa chosowa chofunikira chogwirizana, maselo a T odwala onse adatsegulidwa kuti ayambitse kukula kwa ex vivo komwe kumafunikira chikhalidwe chapadera cha bioreactor.
  • Komanso, chifukwa wodwala wawo nthawi zambiri amadwala kwambiri, ma T cell awo amakhala okhwima, amasiyanitsidwa ndipo mwina amakula mopanda pake, kotero kasitomala wathu amafunikira kukulitsa selo mumikhalidwe okhwima kwambiri chikhalidwe.

Kuti tikwaniritse mfundo ziwirizi, tidalimbikitsa kasitomala wathu eLAB® Advanced ⇀. Chifukwa cha zida izi, zomwe zidapangidwa mosiyanasiyana m'malingaliro, bioreactor yathu idawapatsa mphamvu kuti azikula bwino kwambiri ndikuwongolera zikhalidwe zosiyanasiyana za T cell za odwala awo, zomwe zimawathandiza kusintha chikhalidwe chawo pogwiritsa ntchito automatic control unit yoyendetsedwa ndi Industrial PLC. Ndi izo, adatha kukhala ndi mphamvu zonse pazigawo zofunika - monga kutentha, pH, mpweya wosungunuka, ndi liwiro lachisokonezo - mpaka 12 zikhalidwe zodziimira payekha panthawi imodzi ndi kudalirika komanso kuchita bwino.

Makasitomala yemweyo, powona zotsatira zabwino zam'mbuyomu ndi TECNIC zida ndi chithandizo, adaganiza zokulitsa imodzi mwa mizere yawo yapitayi yogwiritsira ntchito mankhwala a allogenic, omwe anapangidwa m'magulu akuluakulu kuchokera kumagulu operekera osagwirizana monga mafupa. Pofuna kuti chithandizo cha allogenic cell chifikire kwa odwala, maphunziro awo a kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kabwino kake autokupanga mamatic mu zikhalidwe za 50 L.

 

Onani zida zathu zonse

Ma bioreactor athu adapangidwa kuti azigwiritsidwa ntchito mosiyanasiyana, kuwonetsetsa kuti zikuyenda bwino komanso zabwino. Dziwani zambiri zamayankho athu asayansi yazachilengedwe, kuphatikiza ma Bioreactors, Tangential Flow Filtration system, ndi zina zambiri. Pitani patsamba lathu kuti mumve Ma bioreactors ⇀, Kusefera kwa Tangential Flow ⇀ndipo Lumikizanani ndi ⇀ kuti apitirize information ndi kufunsa.