GAiT.Global – The Global Alliance for iPSC Therapies

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.

The website of the #EFI2020 is online! For all details on the next conference visit https://t.co/4gVrobQu7E

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Cell and Gene Therapy Catapult @CGTCatapult·

17 May 1129427665394520065

Commenting on the announcement CEO Keith Thompson said, “With new analytical technologies we will help ensure that cell and gene therapy developers are able to tailor, control and release their products rapidly and efficiently” #analytics #qualitycontrol - https://t.co/Ql5CAcZXAx

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GAiT @IPSCtherapies·

17 May 1129433164353626112

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

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GAiT @IPSCtherapies·

17 May 1129427846013882369

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.

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Cell and Gene Therapy Catapult @CGTCatapult·

17 May 1129349229145710592

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

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Cell and Gene Therapy Catapult @CGTCatapult·

16 May 1129072819436969984

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

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New York Stem Cell Foundation Research Institute @nyscf·

16 May 1129025235255275520

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

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ARM @alliancerm·

15 May 1128662921222021121

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

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GAiT @IPSCtherapies·

15 May 1128630779641253889

GAiT will speak this month at ISCT2019 (Melbourne) on building a global haplobank network for clinical-grade induced Pluripotent Stem Cells.

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GAiT @IPSCtherapies·

14 May 1128324118355546118

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 ...

bioprocessintl.com

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