Many serious diseases have no known cure. Stem cells offer new hope as a treatment for several of these diseases, including arthritis, diabetic complications, several cancers, liver diseases and more. Hundreds of clinical trials are in progress, testing these new regenerative medicine therapies.
When the clinical trial processes have been successfully completed, the demand for stem cells will sky-rocket. This is a major issue – today, the production of stem cells, is a complex, highly-skilled, and labour-intensive task, with a high risk of contamination or human error. A large laboratory, with several staff working together in carefully-controlled clean-rooms, can meet the needs of a clinical trial for a few dozen to a hundred patients. But when a cell therapy has been proven for a disease with thousands, or millions, of sufferers, there simply won’t be enough stem cells available to meet the demand.
AUTOSTEM is developing an automated production line for stem cells. It starts with a bone marrow donation, taken from the hip bone of a donor using a novel suction device being developed by the project. This is transferred in a sterile manner into a production line, where a robotic arm supports the isolation of stem cells from the bone marrow, the culturing of the stem cells in a bio-reactor, and the delivery (at the end of the production line), of very large numbers of these cells. The production line also includes real-time process management, monitoring of cell quality and environment, maintenance of the bio-reactor, etc.
Crucially, the entire process involves no hands-on human operations. While the system is of course monitored by scientific staff, the cell production process is entirely automated. This removes much of the risk of error or contamination, so that the pipleline will generate large amounts of high-quality cells, suitable for use in therapy.
You can view and download the Autostem project poster, flyer and Spring 2017 Newsletter in our Media Centre.
Recent publications in peer reviewed journals achieved by AUTOSTEM partners include:
“Developing an automated robotic factory for novel stem cell therapy production” (Qasim A Rafiq, Karen Twomey, Michael Kulik, Christian Leschke, John O’Dea, Sarah Callens, Chiara Gentili, Frank P Barry, Mary Murphy). Regenerative Medicine 11/4 351-354. DOI: 10.2217/rme-2016-0040. Link to article here.
“Cell and gene therapy manufacturing: the necessity for a cost-based development approach” (Richard P Harrison, Qasim A Rafiq & Nicholas Medcalf). Cell and Gene Therapy Insights 2/1 489-497. DOI: 10.18609/cgti.2016.014. Link to article here.
“Automation in the context of stem cell production – where are we heading with Industry 4.0?” (Michael Kulik, Jelena Ochs, Niels König, Robert Schmitt). Cell and Gene Therapy Insights 2/4 499-506. DOI: 10.18609/cgti.2016.060. Link to article here.
“The evolving role of automation in process development & manufacture of cell & gene-based therapies” (Qasim A Rafiq, Robert J Thomas) Cell and Gene Therapy Insights 2/4 473-479. DOI: 10.18609/cgti.2016.058. Link to article here.
“Advances in automation for the production of clinical-grade mesenchymal stromal cells: the AUTOSTEM robotic platform” (Jelena Ochs, Frank Barry, Robert Schmitt & J Mary Murphy) Cell and Gene Therapy Insights 2017; 3(8), 739-748. DOI: 10.18609/cgti.2017.073. Link to article here.