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toggle navigation home what is autostem? the consortium related research news innovations media centre facebook twitter linkedin a production line for stem cell manufacture project news 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 coordinator, nui galway chiara gentili university of genoa michael kulik fraunhofer ipt karen twomey tyndall-ucc ciaran clissmann pintail ltd john o’dea crospon ltd sarah callens cell therapy catapult qasim rafiq aston university frank barry orbsen therapeutics christian leschke zellwerk gmbh partner organisations the project brings together a multidisciplinary team nui galway the project is led by dr mary murphy of the national university of ireland, galway, who have extensive cell therapy experience and gmp-accredited cell production facilities. crospon the cell extraction device is being developed by irish sme crospon. crospon has experience of designing, building and validating ce-approved devices in the past. orbsen cell isolation technology is provided by irish sme orbsen therapeutics, who have unique capabilities and ip in the prospective isolation of stem cells. zellwerk zellwerk, berlin, contribute their unique zrp bio-reactor, which combines unique ceramics with innovative control systems. fraunhofer ipt the pipeline is built by the fraunhofer ipt in aachen. it will benefit from ipt’s experience in the project ‘stemcellfactory’. aston university aston university, birmingham, are leading researchers in bioreactors, micro-carriers and large-scale cell production. tyndall-ucc sensor technology for controlling the cell culture environment is being developed by the tyndall institute, at university college cork university of genoa the cells produced by the pipeline will be tested and validated in vivo by the university of genoa, italy catapult risk assessment, health economics and process optimisation are supported by the uk’s cell therapy catapult. pintail administration, dissemination activity and exploitation planning are supported by irish sme pintail helping to make routine use of stem cells in the clinic a reality. get in touch send message autostem remedi nui galway ireland this project has received funding from the european union’s horizon 2020 research and innovation programme under grant agreement no 667932. the material presented and views expressed here are the responsibility of the author(s) only. the eu commission takes no responsibility for any use made of the information set out. © autostem

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http://www.autostem2020.eu/the-project/
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http://www.autostem2020.eu/related-research/
http://www.autostem2020.eu/media-centre/
http://www.autostem2020.eu/the-consortium/
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Language: en
Phone: +1.4252744500
Fax: +1.4259744796
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