GAiT has written an Organization Profile article for Regenerative Medicine.
The Global Alliance for iPSC Therapies – An Organizational Profile
Abstract
The Global Alliance for iPSC Therapies is a new non-profit organization focused on building of a global haplobank network for clinical-grade iPSC lines so that these are an appropriate starting material for subsequent development of new allogeneic or ‘off-the-shelf’ therapeutics. GAiT activity is currently funded by four Founder Organizations: the Centre for Commercialization of Regenerative Medicine, the New York Stem Cell Foundation, the Cell and Gene Therapy Catapult, and the Korean HLA-matched iPSC Banking Initiative.
GAiT has recently published the first iteration of its Quality Control Guidelines for clinical-grade iPSCs to be housed in its network, built a virtual portal to enable community data sharing and peer-to-peer technical and regulatory discussion on generating and testing clinical-grade iPSC lines. The non-profit is currently developing a searchable database for HLA-haplotyped clinical-grade iPSC lines, is conducting a ‘Quality Round’ to align testing where Pharmacopeial guidance is currently not available, and is working with the Anthony Nolan Institute and the World Marrow Donor Association to estimate the optimal balance of HLA homozygous cell lines required on a global basis.
In the future, the organization will support research into the immunogenicity of iPSC-derived cell therapeutics. GAiT’s overall mission is to enable the global human community the opportunity to benefit from the new generation of cell therapies by facilitating the development of, and access to, clinical-grade and haplotyped induced pluripotent stem cells for the manufacture of cell therapy products.
