AUTOSTEM | Development of closed, scalable and AUTOmated robotic systems for therapeutic STEM cell manufacturing: aseptic systems from “Donor-to-Patient”

Summary
AUTOSTEM will develop closed, scaleable and automated systems for therapeutic cell manufacture. The project vision is a donor-to-patient system where all aspects of processing, from tissue harvest to patient delivery are fully closed and aseptic. The process will involve new methods of biological cell selection from marrow, fat or other tissues, bioreactors to achieve scale and media formulations that are fully xeno-free. Process monitoring will utilise remote sensing and the automated retrieval of cells for microscopy, flow cytometry, karyotyping, differentiation or other tests. The final product will be a cryobag containing a specified cell dose, ready for thawing and clinical delivery.

AUTOSTEM will be the factory of the future for therapeutic cell manufacturing. This system could ultimately be scaled for hospital-based use to produce autologous cells or at industrial scale for allogeneic therapy. It will achieve consistent cell production, minimise contamination, maximise scale and reduce cost of goods, thus enabling routine clinical use of cell therapies.

The consortium will be a partnership of academic centres and industry with expertise across the disciplines relevant to the research and development goals. It will also include expertise in GMP and regulatory compliance and in healthcare economic analysis.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/667932
Start date: 01-01-2016
End date: 31-12-2018
Total budget - Public funding: 5 995 761,25 Euro - 5 995 761,00 Euro
Cordis data

Original description

AUTOSTEM will develop closed, scaleable and automated systems for therapeutic cell manufacture. The project vision is a donor-to-patient system where all aspects of processing, from tissue harvest to patient delivery are fully closed and aseptic. The process will involve new methods of biological cell selection from marrow, fat or other tissues, bioreactors to achieve scale and media formulations that are fully xeno-free. Process monitoring will utilise remote sensing and the automated retrieval of cells for microscopy, flow cytometry, karyotyping, differentiation or other tests. The final product will be a cryobag containing a specified cell dose, ready for thawing and clinical delivery.

AUTOSTEM will be the factory of the future for therapeutic cell manufacturing. This system could ultimately be scaled for hospital-based use to produce autologous cells or at industrial scale for allogeneic therapy. It will achieve consistent cell production, minimise contamination, maximise scale and reduce cost of goods, thus enabling routine clinical use of cell therapies.

The consortium will be a partnership of academic centres and industry with expertise across the disciplines relevant to the research and development goals. It will also include expertise in GMP and regulatory compliance and in healthcare economic analysis.

Status

CLOSED

Call topic

PHC-16-2015

Update Date

26-10-2022
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Horizon 2020
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.3. Treating and managing disease
H2020-EU.3.1.3.0. Cross-cutting call topics
H2020-PHC-2015-two-stage
PHC-16-2015 Tools and technologies for advanced therapies