Towards the reality of large scale production of human stem cells

The Electrospinning Company is a member of the HESUB consortium, which has been awarded €5.7 million over three years by the European Union 7th framework programme to develop a single-use bioreactor for the cost-effective production of human stem cells. The project started on 1 May 2013.

Stem cell-based therapy holds great promise for a number of diseases including heart disease, diabetes, neurodegenerative diseases, musculoskeletal disorders and autoimmune diseases. However, implementation is held back by a number of factors including the lack of ability to manufacture stem cells in a large scale. Current methods, which rely on expansion of cells in 2D in static culture, are labour intensive and inefficient. In addition, inherent variations in the cell environment, for example in pH, nutrient availability and accumulation of toxic by-products, are issues that also have to be resolved in order to achieve a reproducible production of high quality cells. The consortium is developing a perfusion bioreactor to provide a stable environment for expansion of stem cells by continual renewal of the culture medium, which will be subject to constant monitoring by integrated miniature sensors. The cells will be grown in an innovatively designed 3D nanofibre scaffold environment that is protected from shear stress, which can adversely affects cell signalling and differentiation. The system will be validated and optimised for the production of myogenic stem cells, which hold promise for the treatment of the incurable muscle-wasting disease Duchenne muscular dystrophy, which afflicts 1 in 3,500 boys born worldwide. The production of neural cells derived from human embryonic stem cells and hepatic cells will also be included for the proof-of-concept of the new bioreactor.

The consortium brings together the expertise of five complementary partners from across Europe. Technology from three SME partners will be combined into an innovative perfusion Single-Use-Bioreactor capable of producing enough stems cells for one therapeutic treatment per day, a step-change improvement over current industry standards: bioreactor and perfusion technology from Stobbe tech A/S of Denmark; 3D electrospun nanofibre scaffolds from The Electrospinning Company Ltd of the UK; and single-use chemical optical sensors from Presens GmbH of Germany. A fourth SME, 3H Biomedical in Sweden, will develop new media, bioassays and scalable production guidelines that will support the growth of high quality myogenic stem cells suitable for use in downstream therapeutic applications. The fifth partner is Kungliga Tekniska Högskolan (KTH, Royal Institute of Technology, Stockholm), specialised in bioprocessing towards biopharmaceutical and human stem cell productions. The project builds on results obtained in other European funded projects (Bio-Comet, Atlantis, MyoAMP and Reliver).

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