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
#PLE2019 Cell therapy developers need clear strategies around QC testing (in house or 3rd party?) and what assays to use to test quality of intermediate materials and products.
GMP is not a grade - tells you nothing about quality! Up to developers to justify their level of quality according to ultimate application. #PLE2019
#PLE2019 ATMP manufacturing capacity needs to be increased. More facilities, more flexibility and access to facilities critical. Lack of agility can arise from lack of capacity. Training of personnel also critical.
Developers need to consider and act to surmount three challenges: regulation, science, and pricing. We must act to reduce manufacturing costs for AMTPs in the EU #PLE2019
Have a questions/topics you wish addressed at the GAiT regulatory virtual workshop (to be hosted online October 3rd 2019)? Feel free to DM or email us.
Prof Marc Turner, Dr Jacqueline Barry, and Dr Stephen Sullivan from GAiT will speak at Phaciliate Leaders Europe in London 17th/18th September 2019
The agenda for this years conference has been designed to address the 3 core challenges presented by the European advanced therapies market: investmen...
Thanks to all at the Centre for Stem Cell Research (CSCR) at the CMC Vellore, India for an excellent symposium. We discussed the importance of adopting international standards and norms for iPSC manufacture and building quality into the process from the beginning.