Single-Use unit and Process Analytical Infrared Spectroscopy

Información del proyecto

SUPAIR Spectroscopy

Identificador del acuerdo de subvención: 954732

DOI

10.3030/954732

Proyecto cerrado

Fecha de la firma de la CE 30 Abril 2020

Fecha de inicio 1 Mayo 2020

Fecha de finalización 30 Abril 2022

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 1 880 327,50

Aportación de la UE

€ 1 316 229,25

Coordinado por

IRUBIS GMBH
Germany

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

Período documentado: 2021-02-01 hasta 2022-04-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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