Periodic Reporting for period 1 - iSTantibody (An innovative & seamless approach for the mass spectrometry analysis of monoclonal antibodies)
Período documentado: 2019-05-01 hasta 2019-08-31
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.
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.
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.
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.
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.