Demand for induced pluripotent stem (iPS) cells threatens to outstrip supply, despite the proliferation of stem cell banking initiatives, many of which are simply too small to achieve industrial scale. Worse, the many research projects that generate iPS cells have little motivation to produce stem cell surpluses, though they could easily do so. Such surpluses would be remain idle and unproductive, since researchers typically lack the financial, technical, and human resources to distribute iPS cells to each other.
To resolve this bottleneck in the distribution of iPS cells, a consortium of 26 partners has formed to establish the European Bank for Induced Pluripotent Stem Cells (EBiSC) with support from the Innovative Medicines Initiative (IMI). The EBiSC, a €35 million ($47 million) project, will start systematically cataloging and distributing IPS cells at the necessary scale to keep pace with their generation and satisfy growing demand.
The consortium is a public-private partnership project. It includes six companies representing the European Federation of Pharmaceutical Industries and Associations (EFPIA); six small and medium enterprises (SMEs); and 14 universities, research organizations, public bodies, and nonprofit groups. One of the six EFPIA representatives, Pfizer’s Neusentis research unit, has undertaken the iPS bank’s conceptualization and coordination. One of the SMEs, Roslin Cells, will manage the EBiSC.
The EBiSC’s goal is to demonstrate an operational banking and distribution service of iPSC lines after three years and to establish subsequently for Europe a centralized, not-for-profit bank providing all qualified users with access to scalable, cost-efficient, and customized products. Qualified users would include researchers across academia and industry in the study of disease and the development of new treatments for them.
Although private entities are well aware of the value of iPS cells for research and development, they regard the generation of stem cells as precompetitive work. This sentiment was expressed by Ruth McKernan, CSO of Pfizer’s Neusentis research unit, in a press statement about the EBiSC: “We are excited to be a part of this precompetitive collaboration to build a sustainable repository of high-quality human iPS cell lines. For many areas of research in academia and in industry, understanding the biological basis of disease heterogeneity is the next horizon. A bank of well-characterized iPS lines with strong relevance to the entire research community will help us all in our mission to bring therapies to patients.”
The EBiSC’s main facility will be at the Babraham Research Campus (Cambridge, U.K.) and will undertake cell expansion, quality control, and characterization. The European Cell Culture Collection (ECACC) of Public Health England (Department of Health, U.K.) will coordinate cell-line distribution. The Fraunhofer IBMT (Saarbrücken, Germany) will provide comprehensive operational back up.
The EBiSC intends to reach a capacity of 10,000 cell lines and to eventually process over 1,000 lines in annual sales. By following a phased business strategy, the EBiSC means to:
- hot-start distribution of lines contributed by iPSC Centers in 2014;
- reach full-scale operations in 2016;
- secure extended funding to become a self-sustaining not-for-profit by 2019.
Aidan Courtney, CEO of Roslin Cells said, “We will keep abreast of the fast moving progress in the field of how to make these cells and also provide an online resource to pool the results of research undertaken with the catalogue items that we distribute. In this way, EBiSC will create an ever-increasing wealth of iPS cells, data, and knowledge, which will help advancing drug development and health research.”