title: Setting Up a Haplobank: Issues and Solutions.
abstract: The development of induced pluripotent stem cells offers the possibility of the scalable manufacture of cellular therapies for regenerative medicine. Moreover, donors can be selected on the basis of major transplant antigen systems to match the widest possible number of recipients worldwide, reducing the likely risk of immunological rejection and the degree of immune suppression or tolerance required. If such cell lines are to be broadly available, there will need to be mutual recognition of common standards across different jurisdictions. Extensive international collaboration will be required around issues such as determination of the optimal homozygous human leukocyte antigens (HLA) panel, donor selection, screening and consent, good manufacturing practice (GMP), standards and quality control and regulatory legislation. The challenges in establishing a global GMP induced pluripotent stem cell (iPSC) haplobank are formidable. We argue that now is the time to attempt to reach international agreement around common standards for GMP iPSC manufacture before the field develops in a fragmented manner.
authors.affiliation: Cell Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Barry
authors.affiliation: Cell Therapy Catapult, 12th Floor Tower Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT UK ; Division of Biotechnology/IFM, Linköping University, Linköping, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Hyllner
authors.affiliation: National Institute of Biological Standards and Controls, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG UK.
authors.forename: Glyn
authors.initials: G
authors.lastname: Stacey
authors.affiliation: Histocompatibility and Immunogenetics (Tissue Typing) Laboratory (Box 209), Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Hills Road, Cambridge, CB2 0QQ UK.
authors.forename: Craig J
authors.initials: CJ
authors.lastname: Taylor
authors.affiliation: Scottish National Blood Transfusion Service, 21 Ellen's Glen Road, Edinburgh, EH17 7QT Scotland UK ; Scottish Centre for Regenerative Medicine, University of Edinburgh, Edinburgh, Scotland UK.
authors.forename: Marc
authors.initials: M
authors.lastname: Turner
keywords: Good manufacturing practice; HLA matching; Induced pluripotent stem cells