This collaborative research arrangement combines Roslin Cells’ expertise in developing cGMP grade pluripotent stem cells with Lonza’s expertise in primary cell media formulation. It will allow the companies to share technologies, know how, and other intellectual property in order to accelerate the development of industry leading PSC culture media and systems for use in both research and clinical applications.
A Wellcome Trust funded project, evaluating the potential of using stem cells to generate red blood cells for use in transfusions. Led by the Scottish National Blood Transfusion Service the other project participants in the £3 million research programme are Roslin Cells, NHS Blood and Transplant, the Irish Blood Transfusion Service, and the Universities of Glasgow and Edinburgh.
Roslin Cells’ role is to supply both research and clinical grade stem cells for use in the project and to translate the differentiation protocols developed in the project to GMP standards.
This collaborative project with the University of Glasgow, British Heart Foundation Glasgow Cardiovascular Research Centre, funded by the Technology Strategy Board, involved the translation of research based protocols for production of endothelial cells to a process compliant with the requirements for production of clinical material. The project was successful in translating the protocols, generating functional ECs from human embryonic stem cells (hESC) with the intention of use in a First in Man study and represents a significant advance towards the long term goal of treating patients such as those with ischemic conditions.
Roslin Cells role was to translate the research based process to a GMP compliant process and manufacture endothelial using the compliant protocol. The translation activities included implementing iterative process development requirements, developing the manufacturing documentation and also developing a suitable quality control regime around the process and for the final product.
In this project Roslin Cells was able to assist Asymptote with the development and testing of their GMP compliant liquid nitrogen free controlled rate freezer.
Roslin Cells undertook an assessment of the freezer unit within our clean room facility for cryopreservation of our stem cell lines. We have subsequently validated a freezer for use in our GMP processing.
This project relied on varied technologies, with both partners bringing unique skills, expertise and knowledge to the collaboration. GlycoMar discovered, developed and extracted potential protein/peptide fractions from normal and regenerative marine invertebrates, which were then supplied to Roslin Cells where they were tested for their ability to support hESC renewal in culture and growth and differentiation potential.
The project was funded by a SMART award from the Scottish Executive and lasted approximately 18months. This project has fostered an ongoing collaborative relationship between the two companies and proved to be an invaluable opportunity to develop an assay protocol for future studies.
This collaboration aims to overcome the current need for the use of animal derived products, such as serum and enzymes, in the maintenance, production and storage of stem cells by developing novel stem cell culture conditions. Current products are considered a disease risk and thus removing these products from the manufacture of cells would represent an important step towards their use as therapies.
BEST-Stem Cells is being coordinated by Dr Paul De Sousa (MRC Centre for Regenerative Medicine, University of Edinburgh and Chief Scientific Officer, Roslin Cells). The research collaboration also includes academic units at the Centre National de la Recherche Scientifique (CNRS) and Institut National de la Sante et de la Recherche Medicale (INSERM) France; Rheinische Friedrich-Wilhelms-Universitaet Bonn, Germany and the Universite de Liege, Belgium; along with partners Bioneer A/S in Denmark; Roslin Cells Limited and Glycomar Limited in Scotland.
Roslin Cells plays an important role in assisting in the translation of all BEST-Stem Cell activities towards GMP standards. Our role includes proving quality advice, guidance and training, conducting assessments of project deliverables for GMP compliance, as well as carrying out inspections of research laboratories/processes and developing targeted action plans to develop or improve the first principle quality standards they operate to.
This Technology Strategy Board funded project, led by the Scottish Stem Cell Network (SSCN), is a UK wide consortium of business and academic partners to develop a Therapy Realisation Pathway Tool (TRPT) to analyse the value chain from discovery, through development, to delivery to the market and impact on the economy. Successful and sustainable businesses in the regenerative medicine industry need to incorporate strategies to address key factors beyond individual business boundaries. The relevant value systems include legal, ethical and financial frameworks, distribution and logistics, and markets and end users willing to adopt and able to pay. Business models need to be well adapted to the needs of the various markets: cellular therapies, delivery systems for cells, genes or small molecules or enabling tools and technologies for stimulating endogenous repair will require different business models and value systems, with unique features including compliance with global regulatory frameworks.
In this project Roslin Cells developed a number of business plan case studies based on three cell therapy products. In developing these business plans we were able to learn from and influence current thinking in terms of the existing and expected regenerative medicine value chain, adoption and flexibility of business models and business planning, economic impact of the regenerative medicine sector, and regulatory requirements. Our business plans helped develop thinking in terms of the value chain/system and help inform the TRPT.
In 2007 the International Stem Cell Forum funded a proposal from the UK Stem Cell Bank to bring together the various centres developing human stem cell banks. In 2008 the International Stem Cell Banking Initiative (ISCBI) was inaugurated. Its purpose is to help develop a global network of stem cell banks through support for existing banks and by encouraging the development of new banks in member countries. It will aid stem cell banks to share knowledge about ethical and regulatory issues in member countries and assist in the development of an agreed set of consensus international minimum standards for banking, characterisation and testing, thereby creating a solid framework for international stem cell banking and research.
Roslin Cells has participated in the ISCBI to input and help shape the development of best standards for stem cell banking. We have also been able to benefit from sharing knowledge and forming partnerships with this international initiative.
The initiative has published guidance for research grade banks which can be accessed here.
Guidance for clinical grade banks is currently in development.
The International Stem Cell Initiative (ISCI) is an international consortium of researchers funded by the International Stem Cell Forum. The first ISCI project examined the markers expressed by human ES cells, confirming that the lines isolated in different laboratories are broadly similar, identifying standard markers for human ES cells. The second project compared different media used for human ES cell culture assessing the common genetic changes that occur in hESC during prolonged culture. A third project is now in progress to reach a consensus on functional tests to assess the degree of pluripotency of human ES and iPS cells.
Roslin Cells contributes to the ISCI through providing samples of its cell lines for analysis to inform the project.
The National Clinical Human Embryonic Stem Cell Forum is a consortium of key individuals and organisations within the UK involved in human ES cell derivation and the development of therapies. The forum includes scientists, derivation centres, regulators and law experts. The forum is divided into three sub-groups - Procurement, Quality and Technical - which examine and inform their areas of expertise.
Roslin Cells participates in all levels of the NChESCF to ensure we maintain best practice in our operations and to be a though leader in developing the latest thinking in this field.