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
With a very heavy heart, we announce the passing of our CEO and co-founder, Susan Solomon, following a long battle with ovarian cancer. We owe all that NYSCF has accomplished to Susan, and no words can express our gratitude and awe for her catalytic impact on stem cell research.
Great panel on regulatory futures for CGT from various perspectives - Niloofar Davoodi, @TakedaPharma, Ian Rees, @MHRAgovuk, Michael von Forstner, @biogen and led by Jacqueline Barry, @CGTCatapult
#advancedtherapieseurope #ate2022 #ate22 #celltherapy #regulatory
Companies developing iPSC-based cell therapies
Characterization of advanced therapies: leveraging advanced #analytics to avoid #FDA holds
Find out the key #assay types needed for successful characterization of #cellandgenetherapy
Read the FastFacts poster, or watch the video, here: http://bit.ly/3AxQmMz
GAiT looks forward to speaking to Indian Colleagues from CMC Vellore at the 7th Cell and Gene Therapy Symposium 1st -3rd September 2022. http://www.cscr.res.in/symposium