GAiT is an international resource to facilitate the therapeutic use of immunogenetically matched, clinical-grade new types of stem cells (iPSCs) for the benefit of patients globally. GAiT’s vision is that patients globally will have equity of access to this new generation of iPSC-derived cell therapy products.
GAiT’s 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.
- Achieve consensus on donor selection and screening criteria and consent standards.
- Achieve global consensus on manufacturing and quality parameters and standards required to consider an iPSC line to be of clinical grade and develop an external quality assurance scheme to facilitate the development of comparability between centres.
- Gain agreement with regulators in various jurisdictions as to the acceptability of the quality standards proposed.
- Develop a database of clinical grade iPSC lines.
News & Events
The latest from GAiT
EMA flowcharts and checklists for ATMP regulatory requirements
Advanced therapy medicinal products: Overview - European Medicines Agency
Advanced therapy medicinal products: Overview
GAiT is hosting another Industry Liaison Meeting today where the agenda and format of the iPSC Industry Workshop @Phacilitate Advanced Therapies week will be discussed and decided. The meeting is chaired by GAiT Director @MichaelMay5 and @CIRM_F's Noriko Shimasaki
Thanks to all iPSC Quality Assessment Round authors for your final edits. We will now review, amend and move to submit the manuscript for peer review.
A scheduling poll has been sent out to GAiT Industrial Liaison Committee Members to schedule November's meeting. Please respond by 5th November. Thank you.
Save the date: GAiT iPSC Industry Workshop Tuesday 25th January 2021 9.30am - 2.30pm @Phacilitate Advanced Therapies Week.
The deadline for comments/questions/suggested edits for the Quality Assessment Round Manuscript is this Sunday, 31st October 2021. If authors cannot access the manuscript, please contact firstname.lastname@example.org directly.
In GAiT's next publication, we list practical recommendations and resources for efficient iPSC manufacture: this includes educational material developed by the @ISCTglobal and the Andalusian Network for the Design and Translation of Advanced Therapies https://isctglobal.org/resources/training-programs/andtat
Looking forward to meeting GAiT members at the annual @NYSCF meeting http://www.nyscf.org/events
The iPSC Quality Assessment Round Data Manuscript has been sent to all Authors for final review. Please check your inboxes. We shall submit the manuscript after responding to final questions and comments.
The iPSC Quality Assessment Round Manuscript is to be circulated to all authors tomorrow for final review & edit before submission. Authors will have two weeks to review. Well done to all Organizers and Participants for getting this far, especially with all the COVID disruption.