GAiT.Global – The Global Alliance for iPSC Therapies

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Welcome to GAiT

The Global Alliance for iPSC Therapies

About Us

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.

our mission

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.

Our Objectives

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 @IPSCtherapies·

14h 1173961025412112384

#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.

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GAiT @IPSCtherapies·

14h 1173957716009725952

Very interesting panel around quality and manufacturing #PLE2019

Twitter feed video.

Image for the Tweet beginning: Very interesting panel around quality

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GAiT @IPSCtherapies·

17h 1173915364348047361

GMP is not a grade - tells you nothing about quality! Up to developers to justify their level of quality according to ultimate application. #PLE2019

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GAiT @IPSCtherapies·

19h 1173888027162292224

#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.

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GAiT @IPSCtherapies·

20h 1173873182115340294

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

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GAiT @IPSCtherapies·

21h 1173858420614713344

Perfect conference weather for Phacilitate Leaders Europe #PLE2019 today

Twitter feed video.

Image for the Tweet beginning: Perfect conference weather for Phacilitate

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GAiT @IPSCtherapies·

12 Sep 1172093301320757248

GAiT is looking forward to speaking at 2nd Korean ISCBI symposium 24th-25th September 2019 https://t.co/giKC9BUytg

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GAiT @IPSCtherapies·

27 Aug 1166368025819471872

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.

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GAiT @IPSCtherapies·

7 Sep 1170366869728944128

Prof Marc Turner, Dr Jacqueline Barry, and Dr Stephen Sullivan from GAiT will speak at Phaciliate Leaders Europe in London 17th/18th September 2019

Agenda

The agenda for this years conference has been designed to address the 3 core challenges presented by the European advanced therapies market: investmen...

www.phacilitate-leaders-europe.com

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GAiT @IPSCtherapies·

7 Sep 1170189169294860288

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.

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