Project Overview
A closed, automated and sterile pipeline for large-scale production of therapeutic stromal cells, on-price and on-quality
The challenge
As stem cell therapies enter the mainstream, current laboratory methods to produce cells will not be able to cope.
The Concept
AUTOSTEM will build a production line for stem cells, combining cell production, robotics and process control.
The Innovation
Closed, automated, high-volume cell production. Fewer manual interventions, leading to lower contamination or errors.
Ready for the Clinic
Strict adherence to regulations and standards, risk management and health economics will underpin real-world clinical adoption.
About AUTOSTEM
An automated production line for large-scale stem cell production
Scientists are confident that clinical therapies using stem cells will become reality in the near future. When this happens there will be a massive demand for stem cells.
At present, the cell production process is slow, complex, and labour intensive, involving many manual steps, in a clean-room environment. Critically, it can only produce small amounts of the cells (‘research amounts’) – and will be unable to meet the need for stem cells, when they become a mainstream therapy.
AUTOSTEM is building an automated pipeline that uses industrial approaches (automation, in-process monitoring, process control, closed systems) and novel technologies to produce large quantities of stem cells. Such pipelines will enable us to meet the expected future demand for cells.
The project places great emphasis on regulatory compliance, so that therapies which use our cells will be authorised for clinical use. We also focus on comprehensive process design and risk management, so that this challenging project has the greatest possible chance of success.
Any new therapy must be affordable, if it is to benefit large numbers of patients. From the start, we seek to minimise cost of goods and cost of production.
Novel Technologies
Innovative technologies for marrow aspiration, cell isolation, cell culture medium, micro-carriers and monitoring.
Regulatory and Risk
Focus on meeting regulatory requirements and enabling clinical applications. Rigorous process design, risk minimisation and commitment to consistency and quality.
Building on Success
AUTOSTEM benefits from facilities and experience including StemCellFactory, PurStem and ADIPOA-2 projects.
Beyond Stem Cells
The pipeline, technologies and know-how will be applicable across a wide range of cell production challenges.
Our Team
The AUTOSTEM partner team leaders.
Mary Murphy
Chiara Gentili
Jelena Ochs
Karen Twomey
Ciaran Clissmann
John O’Dea
Sarah Callens
Qasim Rafiq
Frank Barry
