Single-Use unit and Process Analytical Infrared Spectroscopy

Project Information

SUPAIR Spectroscopy

Grant agreement ID: 954732

DOI

10.3030/954732

Project closed

EC signature date 30 April 2020

Start date 1 May 2020

End date 30 April 2022

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 880 327,50

EU contribution

€ 1 316 229,25

Coordinated by

IRUBIS GMBH
Germany

Periodic Reporting for period 2 - SUPAIR Spectroscopy (Single-Use unit and Process Analytical Infrared Spectroscopy)

Reporting period: 2021-02-01 to 2022-04-30

Summary of the context and overall objectives of the project

IRUBIS GmbH developed within the project a novel analytical device that enables continuous real-time monitoring of bioprocesses using mid-infrared spectroscopy with a single use flow cell. Its market is in process development and manufacturing of biological drugs, such as vaccines. The objective of ‘SUPAIR Spectroscopy’ project was to develop the mid-infrared spectroscopy system in line with the biopharma user requirements and to lay the groundwork for successful market commercialization. The validation and feedback by biopharma companies was essential for the project. Additionally, their feedback as well as the promotion of the results laid the foundation for the commercialization strategy.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first 9 month of the action the hardware and software were developed: a monitoring and control solution, including an algorithm that can monitor glucose and lactate, without extensive calibration model building and a control feature to keep the glucose concentration at a constant level. During the second period ‘Monipa’ was validated, and the manufacturing of the analytical device was adapted based on the feedback from biopharma users to achieve a suitable process analytical technology for the biopharma industry. In parallel a business innovation plan and commercialization plan has been developed and dissemination as well as exploitation activities conducted.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

We see the future impact of ‘Monipa’ on the one hand by enabling an increase of the product gain and to achieve higher quality of biopharmaceutical drugs by a continuous control of the nutrient parameter in the bioprocess. On the other hand, a continuous control and real-time monitoring of nutrients and metabolites in the bioprocess leads to a higher process know-how and decrease the time for process development. In a consequence the new technology brings biopharmaceuticals faster to the patient.

Monipa, real-time monitoring of bioprocesses