Descripción del proyecto
Supervisión de biorreactores mediante espectroscopia de infrarrojos medios
Los productos biofarmacéuticos suelen producirse mediante cultivos de células de mamíferos en los llamados biorreactores. Actualmente su fabricación en dichos biorreactores implica el control manual de parámetros esenciales como los metabolitos y los nutrientes. Medir manualmente su concentración requiere tiempo y puede producir variaciones operativas. Además, un control insuficiente conduce a una baja calidad y cantidad de producto. La empresa alemana IRUBIS GmbH ha desarrollado un sistema de sensores fiable y novedoso que permite la supervisión continua de los biorreactores mediante espectroscopia de infrarrojos medios y celdas de flujo desechables para fabricar fármacos biológicos, como por ejemplo vacunas. La empresa ha obtenido la validación comercial y técnica a través de pruebas piloto con socios del sector biofarmacéutico. El proyecto SUPAIR Spectroscopy, financiado con fondos europeos, se propone concluir el desarrollo tecnológico y sentar las bases para una comercialización satisfactoria.
Objetivo
Biopharmaceuticals are medical drugs typically produced by mammalian cells in so-called bioreactors. It takes on average 10-15 years to bring a new drug to the market. Biomanufacturing costs can account for up to 30% of the overall costs needed to approve a new medicine. Currently, monitoring of bioproduction is mostly performed by using offline equipment that lacks robustness and has a reduced operational flexibility. Bioreactors are increasingly being monitored online and on real-time by means of Process Analytical Technologies (PAT). However, state-of-the-art techniques render both sub-optimal product quality and product efficiency. A few existing technologies based on Raman spectroscopy are highly expensive and probes are not robust enough, requiring consecutive sterilisation steps to be reused (raising water and energy consumption).
At IRUBIS GmbH (spin-off of the Technical University of Munich), we have developed SUPAIR, a novel and robust ATR-MIR Sensor System aiming to make online and single-use monitoring of bioreactors by mid-infrared spectroscopy to become standard in the manufacturing of medical drugs. This approach will lead to increased operational flexibility, reduced costs of the manufacturing process, and will accelerate time-to-market of higher quality medicines to the patients. In the course of the Phase 1 project, we have validated our technical and commercial roadmaps through pilot testing with relevant biopharmaceutical players. Now we are getting closer to market, and we expect to conclude all technical developments and lay the ground for a successful market commercialisation by undertaking EIC Accelerator Pilot project.
Ámbito científico
Not validated
Not validated
- engineering and technologymechanical engineeringmanufacturing engineering
- engineering and technologyenvironmental biotechnologybioremediationbioreactors
- natural sciencesphysical sciencesopticsspectroscopyabsorption spectroscopy
- engineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensors
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-EIC-SMEInst-2018-2020-3
Régimen de financiación
SME-2 - SME instrument phase 2Coordinador
80335 MUNCHEN
Alemania
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.