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Publication
Impacto dos biorreatores de perfusão na produção de biofármacos
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| PPG_12997 | 3.39 MB | Adobe PDF |
Advisor(s)
Abstract(s)
Os biorreactores têm um papel central na indústria biofarmacêutica, como sistemas
artificiais de crescimento e manutenção das culturas celulares. Este facto motivou
contínuos esforços nos últimos 50 anos com vista ao seu aperfeiçoamento em
termos de desenho e operacionalidade visando a obtenção de unidades processuais
cada vez mais eficientes.
Apesar das configurações batch e fed-batch serem ainda as mais utilizadas pela
indústria apresentam várias limitações como: elevado tempo de inatividade entre
lotes; volumes finitos de cultura; custos mais elevados e análises prévias
exaustivas de microrganismos e células animais para entender os seus requisitos
em relação à sua formulação e produtividade.
Assim gradualmente a indústria biofarmacêutica tem procurado alterar o
paradigma para a produção em modo contínuo em perfusão. A perfusão é o
processo contínuo de alimentação da fermentação, com cultura permanentemente
fresca, enquanto as células ficam retidas em dispositivos de retenção no biorreator.
A colheita em modo contínuo; a remoção contínua dos produtos instáveis; a maior
produtividade de volume; modelos scale-down mais compactos; densidade celular
maior dos produtos; operação de fabrico durante períodos mais longos e a redução
dos custos operacionais são algumas das vantagens que os biorreatores de perfusão
apresentam face aos modelos tradicionais batch e fed-batch.
No momento já existem diversas empresas como a SanofiÓ, MerkÓ e BayerÓ que
já utilizam o bioprocesso de perfusão, nas suas unidades fabris para a produção de
biofármacos.
O presente trabalho, apresenta uma visão do processo biotecnológico que utiliza os
biorreactores em contínuo no modo perfusão procurando antecipar qual irá ser o
seu impacto, na indústria farmacêutica.
Bioreactors play a central role in the biopharmaceutical industry, as artificial systems for growing and maintaining cell cultures. This has led to continuous efforts over the last 50 years to improve its design and operation in order to obtain more efficient units. Although batch and fed-batch reactor configurations are still the most used by the industry, they present several limitations such as: high batch downtime; finite volumes of culture; higher costs and a thorough pre-analysis of microorganisms and animal cells in order to understand their requirements in terms of formulation and productivity. Gradually the biopharmaceutical industry has sought to change the paradigm for continuous production in perfusion configuration, a continuous fermentation feed process, with a permanently fresh culture, while the cells are retained in retention devices in the bioreactor. Continuous harvesting; the continuous removal of unstable products; higher volume productivity; more compact scale-down models; higher cell density of the products; manufacturing operation for longer periods and the reduction of operational costs are some of the advantages that the perfusion mode presents. At the moment, there are already several companies such as SanofiÓ, MerkÓ and BayerÓ that already use the perfusion bioprocess, in their plants for the production of biopharmaceuticals. The present work presents a vision of the biotechnological process that uses bioreactors in continuous mode in perfusion seeking to anticipate what will be its impact in the pharmaceutical industry.
Bioreactors play a central role in the biopharmaceutical industry, as artificial systems for growing and maintaining cell cultures. This has led to continuous efforts over the last 50 years to improve its design and operation in order to obtain more efficient units. Although batch and fed-batch reactor configurations are still the most used by the industry, they present several limitations such as: high batch downtime; finite volumes of culture; higher costs and a thorough pre-analysis of microorganisms and animal cells in order to understand their requirements in terms of formulation and productivity. Gradually the biopharmaceutical industry has sought to change the paradigm for continuous production in perfusion configuration, a continuous fermentation feed process, with a permanently fresh culture, while the cells are retained in retention devices in the bioreactor. Continuous harvesting; the continuous removal of unstable products; higher volume productivity; more compact scale-down models; higher cell density of the products; manufacturing operation for longer periods and the reduction of operational costs are some of the advantages that the perfusion mode presents. At the moment, there are already several companies such as SanofiÓ, MerkÓ and BayerÓ that already use the perfusion bioprocess, in their plants for the production of biopharmaceuticals. The present work presents a vision of the biotechnological process that uses bioreactors in continuous mode in perfusion seeking to anticipate what will be its impact in the pharmaceutical industry.
Description
Keywords
Biorreatores Biofármacos Perfusão Bioprocesso contínuo Bioreactors Biopharmaceuticals Perfusion Continuous Bioprocessing