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
The website of the #EFI2020 is online! For all details on the next conference visit https://t.co/4gVrobQu7E
Well done iPSC Quality Round Participants 2019: @astar_research, @BlueRockTx, @CGTCatapult, @CiRA_KU_E, @CCRM_ca, @cmrb, CMC Vellore, @FateThx, @ufrj, @CellDynamics, @Inserm, Korean Institute of Health, @MCRI_for_kids, @nyscf, @givebloodscot , @STEMCELLTech, @usponline @YposKesi
Quality Round Participants are now uploading their data to the Data Portal. We are very grateful to Co-Organizers @STEMCELLTech , @NIBSC_MHRA, @CiRA_KU_E and to @Worldcourier for the viability of this enterprise.
Today Professor Yamanaka @CiRA_KU_E visited the @CGTCatapult manufacturing centre in Stevenage, part of the world leading advanced therapies ecosystem in the UK #stemcells #iPSC #manufacturing - https://t.co/LeRDvyafVL
During the visit Professor Yamanaka @CiRA_KU_E met with @CGTCatapult executives and the group discussed their experiences in the development of iPS cell therapies #stemcells #iPSC #collaboration - https://t.co/w1C1kcbRkA
For those at #WATRMC19, join NYSCF's @liz_schwarzbach, Jacqueline Barry of @CGTCatapult, Jane Lebkowski of Regenerative Patch Technologies, Chaim Lebovits of @BrainstormCell, & Revindra Gupta of @ucl for a discussion happening now on #clinicaltrials for #celltherapies
NEW feature >> ARM just launched our searchable, downloadable database of RM / AT products & product candidates with RMAT, Breakthrough, and/or Fast Track designations in the U.S.; EU PRIME designation; and/or Sakigake designation in Japan. Explore here: https://t.co/NDQiuGs3AQ
GAiT will speak this month at ISCT2019 (Melbourne) on building a global haplobank network for clinical-grade induced Pluripotent Stem Cells.
FDA: In contrast to traditional drug development, when it comes to cell and gene therapies some of the more challenging questions relate to product manufacturing and quality, safety.
FDA pledges to support cell and gene therapy manufacturing innovation - BioProcess International
Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms ...