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.