Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application

AbstractFrom 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources

Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements

# The Author(s) 2014. This article is published with open access at Springerlink.com Abstract This article compares and contrasts the pressures of both open access data sharing and commercialization policies in the context of publicly funded embryonic stem cell research (SCR). First, normative guidelines of international SCR orga-nizations were examined. We then examined SCR funding guidelines and the project evaluation criteria of major funding organizations in the EU, the United Kingdom (UK), Spain, Canada and the United States. Our survey of policies revealed subtle pressures to commercialize research that include: in-creased funding availability for commercialization opportuni-ties, assistance for obtaining intellectual property rights (IPRs) and legislation mandating commercialization. In lieu of open access models, funders are increasingly opting for limited sharing models or “protected commons ” models that make the research available to researchers within the same region or those receiving the same funding. Meanwhile, there still is need for funding agencies to clarify and standardize terms such as “non-profit organizations ” and “for-profit research,” as more universities are pursuing for-profit or commercial opportunities. Keywords Stemcell research(SCR).Humanembryonicstem cells (hESC). Induced pluripotent stem cells (iPSC). Open access. Data sharing. Commercialization Abbreviations hESC human embryonic stem cells iPSC induced pluripotent stem cells IPRs intellectual property rights MTA material transfer agreement SCR stem cell research SLA simple letter agreement TTO technology transfer offic