An innovative & seamless approach for the mass spectrometry analysis of monoclonal antibodies

Project Information

iSTantibody

Grant agreement ID: 866021

DOI

10.3030/866021

Project closed

EC signature date 15 April 2019

Start date 1 May 2019

End date 31 August 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

PREOMICS GMBH
Germany

Periodic Reporting for period 1 - iSTantibody (An innovative & seamless approach for the mass spectrometry analysis of monoclonal antibodies)

Reporting period: 2019-05-01 to 2019-08-31

Summary of the context and overall objectives of the project

PreOmics GmbH is a spin-off of the Max-Planck Institute of Biochemistry founded in 2016. We are currently developing iSTantibody, a novel product for the seamless preparation of therapeutic monoclonal antibodies (mAbs) and host cell proteins (HCPs) prior to Mass Spectrometry (MS) analysis. It is a unique ready-to-go kit in the market that allows to process 96/384 samples of mAbs concomitantly and at unprecedented speed (< 2.5 h vs > 40h now) without the need of skilled scientists or own reagents and compatible with automated liquid handling platforms.
MAbs are manufactured in host cells which may contain certain contaminants (i.e. Host Cell Proteins - HCPs). HCPs affect significantly the functionality of the mAbs and/or lead to adverse effects in patients, thus, they must be identified and quantified with the highest precision and sensitivity. MS-based analysis is a powerful tool for the identification and quantification of HCPs, but the sample preparation for MS analysis is a time-consuming, complex and poorly reproducible process.
The use of iSTantibody by biopharma companies will significantly reduce the cost of mAbs analysis and production (yearly savings of € 500,000 per mAbs pipeline) and will foster the development of new mAbs in a shorter time.

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 last 4 months we have performed a thorough technical, commercial and financial assessment to assure the successful optimization and launch of iSTantibody in the biopharma market.
The business plan represents a clear route for the development and commercialisation of iSTantibody, considering the funding requirements and strategy to reach the market in 2022, which will generate revenues of 27 million € by 2026 with a ROI of 18.5 and an increment in personnel from 19 to 100 people by 2026.

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)

After the iSTantibody project, we will get an optimized version of the current iSTantibody 8-samples prototype (TRL 7) to 96/384-samples and will reach the EU and North American markets achieving revenues of 17 million € by 2026. The positive impact of the iSTantibody will produce new jobs for qualified personnel in Europe, will allow therapies using mAbs to be developed in shorter periods of time and be used in new diseases and increase EU competitiveness in a global market that is currently dominated by US firms.