Single-Use unit and Process Analytical Infrared Spectroscopy - SUPAIR Spectroscopy

Programme(s):
H2020-EU.3. - PRIORITY 'Societal challenges
H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
Topic(s): EIC-SMEInst-2018-2020 - SME instrument
Call for proposal: H2020-EIC-SMEInst-2018-2020-3
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Funding Scheme: SME-2b - SME Instrument (grant only and blended finance)
Grant agreement ID: 954732
Project description
Monitoring bioreactors using mid-infrared spectroscopy
Biopharmaceuticals are typically produced by mammalian cell cultures in so-called bioreactors. Currently, biopharmaceutical production in bioreactors involves manual control of critical parameters such as metabolites and nutrients. Measuring their concentration manually is time consuming and liable to operative variation. Furthermore, insufficient control leads to low product quality and quantity. The German company IRUBIS GmbH has developed a novel robust sensor system that enables continuous monitoring of bioreactors using mid-infrared spectroscopy and single-use flow cells for the manufacturing of biological drugs, such as vaccines. The company has achieved technical and commercial validation through pilot testing with biopharmaceutical partners. The EU-funded SUPAIR Spectroscopy project aims to conclude technological developments and lay the groundwork for successful market commercialisation.
Objective:
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 o ine equipment that lacks robustness and has a reduced operational exibility. 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 e ciency. 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 exibility, 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 biopharmaceuticalplayers. 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.