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Pre-Conference ISSCR Satellite Meeting 2010 Stem Cell Facilities and Resources: Delivering Cells for TherapyPresented by the UK Stem Cell Bank As the potential of regenerative medicine begins to be realised there will be an ever increasing demand for appropriate banking, testing and production facilities and trained staff. In addition, the availability of labs equipped to provide highly qualified cells, advice and training will be critical to fast track the delivery of cell therapies. This international workshop will incorporate case studies from established and developing banking facilities and resource centres, all ultimately focused on delivery of stem cell therapies. These will lead group discussion to identify key issues in facility and resource development and will attempt to map core requirements for the early preclinical stages of in the development of stem cell therapies and unambiguous nomenclature for stem cell lines. Convener Glyn Stacey UK Stem Cell Bank Case studies: establishing clinical grade facilities for stem cell therapies The New Good Manufacturing Practice (GMP) Facility at UC Davis - Translating Research Into Life Saving Clinical Applications. Dr Gehardt Bauer, University of California Davis. Establishment of a new GMP facility for the UK Stem Cell Bank. Prof. Glyn Stacey, UK Stem Cell bank and Cell Biology and Imaging, National Institute for Biological Standards and Control. Banking activities Massachusetts Human Stem Cell Bank. Dr Meng-Jiao Shi, Lab Director, UMass Human Stem Cell Bank & Registry Integrating Cell Banking, Characterization, and cGMP Production Efforts to Support the Efficient Translation of Stem Cell Therapeutics into Clinical Trials. Tenneille Ludwig, The Wicell Research Institute. International Stem Cell Banking Initiative: Update. Dr Lyn Healy, UK Stem Cell Bank, National Institute for Biological Standards and Control. Development of nomenclature for hESC and iPS cell lines, Dr Mai Luong, UMass Human Stem Cell Bank & Registry. Gerhard Bauer PhD At the Stem Cell Program at University of California Davis, Medical Center, we established a new Good Manufacturing Practice (GMP) laboratory to facilitate translation of bench research to novel clinical applications. Within 15 disease teams, 147 basic, translational and clinical investigators from UC Davis are currently interacting with the Stem Cell Program. The program received 20 million dollars in funding from the California Institute for Regenerative Medicine (CIRM) to build the Institute for Regenerative Cures, which was opened as the first CIRM funded large facility in April of 2010. The new GMP facility is a part of this institute. It is a highly versatile, multi-use GMP facility with six Class 10,000 manufacturing rooms, completely separated from each other. Six different products can be manufactured simultaneously, without interference. The facility features the first BD FACS sorter in a true biosafety cabinet for aseptic, GMP grade FACS sorting; additional unique features are switchable room pressurization on demand from a cellular manufacturing setting to a containment setting needed for FACS sorting or gene therapy vector production. Additionally, the facility contains a GMP grade hot cell for the manufacturing of PET reagents. GMP manufacturing is currently ongoing and encompasses cellular products such as mesenchymal stem cells, induced pluripotent stem cells and gene therapy vectors. With established facility rates, the GMP facility is open to researchers within UC Davis and also to outside academic collaborators and industry researchers. Establishment of a New GMP Facility for the UK Stem Cell Bank Glyn Stacey, PhD, Director for the UK Stem Cell Bank and The UK Stem Cell bank was initiated in 2003 when its remit was to rapidly set up a GMP facility to service any potential clinical grade hESC lines developed in the UK. The initial prototype facility was established by November 2003 and granted a license by the UK Medicines and Healthcare products Regulatory Authority (MHRA) to supply cells and tissues for use in humans in June 2004. Since then the facility has adapted to new European Regulation (EU Tissues and Cells Directive 2004/23/EC) which is implemented in the UK by the Human Tissues Authority from which the UKSCB received its current license in 2009. Also during 2009 UKSCB established its new GMP facility and the presentation will provide an overview of the current facilities-, processing- and cleaning- validation programme that will deliver a fully operational clinical grade facility in 2011. The Bank is also working on an analytical validation programme for its release tests and a qualification process for managing quality data within a new LIMS data management system. The presentation will describe the challenges of operating the UKSCB facility both for supply for supply for development in clinical trials and for research purposes. Massachusetts Human Stem Cell Bank Meng-Jiao Shi PhD, Lab Director The Massachusetts Human Stem Cell Bank (MHSCB) is a repository for human ES and iPS cell lines that are derived in laboratories throughout the world. Located at the University of Massachusetts Medical School, the MHSCB is funded by the Massachusetts Life Sciences Center, an agency that invests in life sciences research and promotes economic development in the state. The Bank is equipped with a full spectrum of "state-of-the-art" equipment and employs comprehensive standard operating procedures for cell culture, characterization and cryopreservation, as well as rigorous quality control systems ensuring that cells distributed to the research community are of optimal quality. The Bank provides human ES and iPS cells to researchers and throughout the world to facilitate studies into the properties and applications of pluripotent stem cells. The Bank also provides training for hESC and iPS cell culture and differentiation techniques. To meet the needs of this rapidly evolving field, the bank is engaged in testing and refining emerging techniques, and supports "proof of principle" projects of investigators in both academia and industry for stem cell research. Integrating Cell Banking, Characterization, and cGMP Production Efforts to Support the Efficient Translation of Stem Cell Therapeutics into Clinical Trials Presenters: The successful translation of pluripotent stem cells into human therapeutics will require the development of manufacturing processes capable of producing consistent batches of cells that meet strict Quality Control testing requirements. Pluripotent stem cells pose several unique and significant manufacturing challenges including control of differentiation, genetic stability, and potential tumorigenicity, properties that may be significantly influenced by cell line characteristics. Efficient and successful transition of pluripotent stem cell research into clinical trials will therefore require high quality, well characterized cell banks capable of supporting therapeutic development from research through to human clinical trials. In order to support the growing field of human ES cell research, WiCell Research Institute has established the Wisconsin International Stem Cell bank (WISC Bank). The WISC Bank practices methods, protocols and quality control standards developed and refined by WiCell for the National Stem Cell Bank (NSCB). Building on the strength of the NSCB, the WISC Bank supports stem cell researchers by banking and distributing human embryonic stem (ES) cell and induced pluripotent stem (iPS) cell lines and developing standardized methods for cell culture, cryopreservation and characterization. Cell lines distributed by the WISC Bank undergo extensive testing and characterization as captured in each lot’s Certificate of Analysis, which is readily available to the public through the WiCell website (www.wicell.org). To further support translational research, WiCell has partnered with the Waisman Clinical Biomanufacturing Facility (WCBF, www.gmpbiomanufacturing.org) at the University of Wisconsin to provide hESC Master and Working Cell Banks (M/WCBs) produced under current Good Manufacturing Practice (cGMP) guidelines. To initiate this program, we produced an H9 (WA09) MCB under cGMPs in the WCBF cleanroom using feeder-independent, defined conditions for cell culture and cryopreservation. Full cGMP documentation was developed for the process and extensive quality control testing was performed on the MCB. In addition to standard testing for identity, genetic stability, purity, and hESC marker expression, comprehensive testing for potential adventitious agents, including murine adventitious agents, was performed in compliance with FDA and ICH guidelines. Future efforts will focus on deriving new cell lines using feeder-independent derivation methods with a goal of providing banks to researchers for development studies with access to matched cGMP banks for future clinical trials. This program will provide broad support for translation investigators with the potential to support an efficient and economical transition of promising research into human clinical trials. International Stem Cell Banking Initiative: Update. Dr Lyn Healy PhD, The International Stem Cell Banking Initiative (ISCBI) is a project funded by a consortium (International Stem Cell Forum, ISCF) which is comprised of national and international funding agencies interested in supporting projects that can only be achieved through broad international collaboration. The ISCBI recently published guidelines on banking testing and distribution of hESCs for research purposes which is also largely applicable to iPSCs. This presentation will outline the key elements of this consensus guidance and the approach used to deliver a balanced consensus document with buy in from banking and regulatory representatives from more than 20 countries. The group has also established a registry of stem cell banks on the ISCF website (www.stemcellforum.org) and a proforma for self evaluation of stem cell banks. However, the main activity currently has been the development of guidance on Points to Consider for the delivery of clinical grade stem cell banks. There are a number of working groups engaged in this work and the presentation will outline the work so far and opportunities for other groups to contribute. Development of Nomenclature for hESC and iPS Cell Lines Mai Luong PhD A convention for naming hESC and iPS cell lines is urgently needed for this exploding field. Certain cell lines have previously been confused with others, and these occurrences are likely to increase with the rapid and abundant derivations of iPS cell lines. The International Stem Cell Registry has initiated a discussion with the stem cell community to develop a systematic approach to naming cell lines. The intent is to allow useful information to be deduced from cell line names, and to help prevent confusion between different cell lines with similar names. Ongoing discussions have considered the types of information (tissue source, clone number, hESC or iPSC) that should be included, as well as the length of the name. A summary of these discussions will be posted at the International Stem Cell Registry as well as the ISSCR-Linkedin discussion board. With maximal input from the stem cell community, successful development of a consensus on naming hESC and iPS cell lines will yield significant benefits for this rapidly evolving field.
Updated June 9, 2010
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