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.

Stem cell production needs an industrial approach if we are to meet the needs of the clinic into the future.

About AUTOSTEM

An automated production line for large-scale stem cell production
Delivering large quantities of high-quality cells for new therapies

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
Mary Murphy
Coordinator, NUI Galway
Chiara Gentili
Chiara Gentili
University of Genoa
Michael Kulik
Michael Kulik
Fraunhofer IPT
Karen Twomey
Karen Twomey
Tyndall-UCC
Ciaran Clissmann
Ciaran Clissmann
Pintail Ltd
John O’Dea
John O’Dea
Crospon Ltd
Sarah Callens
Sarah Callens
Cell Therapy Catapult
Qasim Rafiq
Qasim Rafiq
Aston University
Frank Barry
Frank Barry
Orbsen Therapeutics
Christian Leschke
Christian Leschke
Zellwerk GmbH

Partner Organisations

The project brings together a multidisciplinary team

Helping to make routine use of stem cells in the clinic a reality.

Get in touch