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Author:Vermasvuori, Raisa
Title:Production of recombinant proteins and monoclonal antibodies - Techno-enonomical evaluation of the production methods
Rekombinanttiproteiinien ja vasta-aineiden tuotanto - tuotantomenetelmien teknistaloudellinen vertailu
Publication type:Licentiate thesis
Publication year:2009
Pages:117      Language:   eng
Department/School:Biotekniikan ja kemian tekniikan laitos
Main subject:Tehdassuunnittelu   (Kem-107)
Supervisor:Hurme, Markku
Instructor:
Electronic version URL: http://urn.fi/URN:NBN:fi:aalto-201203151594
OEVS:
Electronic archive copy is available via Aalto Thesis Database.
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Location:P1 Ark TKK  3307   | Archive
Keywords:biopharmaceutical production
economic
biolääke
biolääkkeen tuotanto
taloudellisuus
Abstract (eng): Recombinant proteins and antibodies for therapeutic or diagnostic use can be produced in many host organisms (microbial, insect and mammalian cells), in different bioreactors (stirred-tank bioreactor, hollow fiber bioreactor and disposable bag bioreactors) and using various feeding strategies (batch, fed-batch or perfusion).
The manufacturing cost (euros /g) of the product depends on the characteristics of the production host (growth rate, productivity) and on the production method (cell density in the bioreactor phase and the overall yield).
Most critical variables are the fermentation titer (g/l) and the total yield (%).

The manufacturing costs of production of recombinant proteins and monoclonal antibodies were analyzed for two applications.
In the recombinant protein application the focus was on the effect of production host (E. coli, P. pastoris and Drosophila S2) and in the monoclonal antibody application in different bioreactor setups.
The E. coli was found to be the lowest cost system in HIV-1 Nefprotein production.
In Mab production, the hollow fiber bioreactor was found to have slightly lower manufacturing costs than the perfusion stirred-tank bioreactor.
Also a crystallization method for recombinant HIV-1 Nef protein was developed.
Abstract (fin): Terapeuttisia tai diagnostiikassa käytettäviä rekombinanttiproteiineja ja vasta-aineita voidaan tuottaa useissa eri tuotto-organismeissa (mikrobi-, hyönteis- tai eläinsoluissa), erilaisissa bioreaktoreissa (sekoitusreaktorissa, onttokuitureaktorissa tai kertakäyttöisissä pussireaktoreissa) sekä käyttäen erilaisia tuotantomenetelmiä (panos, puolipanos tai jatkuvatoiminen kasvatus).
Tuotantokustannukset (euroa/g) riippuvat tuotto-organismin ominaisuuksista kuten kasvunopeudesta ja tuottavuudesta sekä tuottomenetelmästä kuten kasvatusvaiheen solutiheydestä sekä kokonaissaannosta.
Kriittisimpiä tekijöitä ovat bioreaktorivaiheen tuotto sekä kokonaissaanto.

Tässä työssä analysoitiin rekombinanttiproteiinin ja monoklonaalisen vasta-aineen pienen mittakaavan tuotannon taloudellisuutta.
HIV-1 Nef-proteiinia tuotettiin erilaisissa tuottoorganismeissa (E. coli, P. pastoris and Drosophila S2) ja vasta-ainetta erilaisissa bioreaktoreissa.
E. coli -bakteerin todettiin olevan edullisin tuotto-organismi HIV-1 Nef-proteiinin tuotannossa.
Vastaaineen tuotannossa, onttokuitureaktorin tuotantokustannukset olivat hieman matalemmat kuin sekoitusreaktorin.
Työssä esitellään myös kiteytysmenetelmä rekombinantti HIV-1 Nef-proteiinille.
ED:2010-03-12
INSSI record number: 39075
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