SUPAIR Spectroscopy: Single-Use Process Analytical Infrared Spectroscopy

Project Information

SUPAIR Spectroscopy

Grant agreement ID: 868454

DOI

10.3030/868454

Project closed

EC signature date 11 May 2019

Start date 1 May 2019

End date 30 September 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

IRUBIS GMBH
Germany

Periodic Reporting for period 1 - SUPAIR Spectroscopy (SUPAIR Spectroscopy: Single-Use Process Analytical Infrared Spectroscopy)

Reporting period: 2019-05-01 to 2019-09-30

Summary of the context and overall objectives of the project

Biopharmaceuticals are medical drugs produced by living cells in so-called bioreactors. Manufacturing costs really matter in this industry and can be as high as 30%. Currently, monitoring of production is carried out offline and employees must come on weekends to regulate the process. A few industry reports stated that current bioprocessing facilities/equipment are inefficient and highly expensive. Companies are willing to implement new technologies to reduce capital investment in equipment, increase operational flexibility and increase speed to market to boost their competitiveness, but also to reduce environmental impact and help patients that are waiting too long for improved therapies.
Biopharmaceutical manufacturers are now encouraged to make investments in the following areas:
Adoption of continuous manufacturing and real-time monitoring technologies to improve operational flexibility and overall scalability; Adoption of single-use and small footprint process analytical technologies to increase flexibility and reduce production lead times, thus lowering capital and operating costs. Energy requirements are minimised as well.
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 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.

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

The work carried out during the Phase 1 project covered tasks related to the technical and practical viability of our innovation, as well as market, commercial and IPR assessments.
First, with the technical feasibility we were able to analyse the current stage of development of our SUPAIR system and based on the outcome we have now a clear insight on further technological developments to define the final specifications of our product. To this end, we have decided that we will perform extensive demonstrations and testing with pilot customers (biopharmaceutical companies and contract manufacturing organisations) to validate the market needs for each customer segment and finally draw the technical roadmap until reach TRL9. This includes the development of new features and the integration and validation of the whole system. We are considering submit a new patent to protect future elements of our final system.
We have also performed a deep analysis of the competitive landscape confirming that we can offer a cost-effective solution with distinctive benefits and a superior performance. The market assessment also validated the high scalability potential of our business model. With Phase 1, we were also able to collect important letters of intent/non-disclosure agreements from relevant players in the biopharmaceutical industry that confirm the willingness to pay for our innovative product. By being close to such partners, we were constantly updating our business plan and pricing policy. Finally, we have drafted a work plan for further technological developments and to pave the way for a successful market launch. The defined tasks will be undertaken by IRUBIS GmbH expectably within the new EIC Accelerator Pilot.

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)

Current state-of-the-art technological solutions include offline and online/inline monitoring of bioprocesses. Offline monitoring cannot enable real time measurements and continuous manufacturing of medical drugs. Existing analytical technologies include expensive and large footprint equipment. On the other hand, current online process analytical technologies despite offering some advantages over offline instrumentation, they are still very expensive and do not offer the ideal robustness to make biopharmaceutical manufacturing affordable.
Our IRUBIS SUPAIR Sensor System was developed to solve the limitations of the aforementioned technologies. SUPAIR comprises a single-use ATR Crystal made of silicon and 100x cheaper than conventional probes and sensors, that is integrated into a flow cell to be read out by a compact and robust MIR spectrometer. Our complete Sensor System costs half of the price of current products. We outcompete the alternatives by providing a cost-effective, robust and easy to use product enabling higher operational flexibility and higher scalability of biomanufacturing processes. Additional benefits of our technology include: i) Reduced environmental impact, as single-use technologies reduce overall energy waste; ii) Establish EU as competitive pole for biomanufacturing industries; iii) relevant social benefits, as we could enable accelerated time to market of better and cheaper medicines to the patients. The overall objective of the SUPAIR project is to unleash the full potential of our disruptive innovation. To do so, we have to complete further development tasks in order to reach TRL9 and launch the product on the market.

Irubis Team