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
GAiT would like to thank all who organized #CGTmfg19 Manufacturing Workshop this week. It was a very interesting and practically useful event.
Today we are organizing shipping of materials for the Quality Round. If you are participating we need you to compete steps 1-5 this week please so we can ship on schedule.
Participating in the Quality Round? We will need you to complete steps 1-5 in the Data Portal if we are to ship materials to you in April. If you have already completed these steps, your invoice will be with you shortly.
The report from the ISCBI workshop, held in collaboration GAiT and the Harvard Stem Cell Institute, Boston 2017 has been accessed for publication in STEM CELLS and should shortly be available to read online with Article ID: STEM3003.
GAiT is attending @CGTCatapult Manufacturing Workshop. Recommended reading is 2019 'Logistics by Design' paper https://t.co/oEHIX4IGJE … A lot to consider when it comes to identifying and solving iPSC manufacturing challenges.
5 of 16 Participants have already completed the first 5 steps of the entire Quality Round process (using the newly activated Data Portal at https://t.co/1WYwnFiXq7 ) . We are happy to see people find it easy to use.
The Quality Round Data Portal is now live. Participants can enter their shipping and billing information and download the Quality Round Data Portal for review.
GAiT is co-hosting a PSC Manufacturing Meeting at USC in Los Angeles 30 JUN 2019. If you are attending ISSCR2019 you might want to stay extra day to participate.
Thanks to co-hosts @ISCTglobal @CIRMnews @HESI_Global & ISCBI
GAiT is gearing up for the iPSC Quality Round it is organising with @NIBSC_MHRA, @STEMCELLTech and @CiRA_KU_E (Kyoto University). Quality Round Participants will be able to access the new Quality Round Data Portal this Friday 08 MARCH 2019 when it goes live.
Watch our Webinar Recording with Jacqueline Barry, Chief Clinical Officer at @CGTCatapult as she discusses ‘Regulatory Strategies to Implement your Manufacturing Processes’. Click here https://t.co/fOH6H0X8Fs #CellularTherapy #GeneTherapy #CellSeriesUS19