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
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.
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
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
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
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
GAiT will speak this month at ISCT2019 (Melbourne) on building a global haplobank network for clinical-grade induced Pluripotent Stem Cells.
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 ...
Register for Pluripotent Stem Cell Manufacturing - Expert Panel Discussion 30 JUNE 2019
Pluripotent Stem Cell Manufacturing Meeting - Expert Panel Discussion
Pluripotent Stem Cell Manufacturing Meeting 2019
GAiT is looking forward to assisting in tomorrow's Core Session at #AutomationSIG: Controlling manufacturing variability by adopting Quality by Design principles
GAiT is participating in #automationSIG which will focus on quality, cost, safety & scalability of iPSC and other cell therapies. #beginwiththeendinmind
#RESTOREkickoff: Importance of starting PSC manufacturing with appropriate donor material & having strong focus on Quality from outset seen as important. Challenges of manufacturing at scale & demonstrating comparability still not fully appreciated by a general audience though.
Marc Peschanski of I-Stem on the economics of manufacturing iPSC therapies for Europe at #RESTOREkickoff
Fine overview of the need for cell therapy development in Europe at #restorekickoff
GAiT is speaking in Berlin today at the #RESTOREkickoff event. Our current efforts with the Quality Round will be discussed.
GAiT will be attending the RESTORE kickoff in Berlin 5-7 MAY 2019 () and AUTOMATION SIG in Baveno 8-9 MAY 2019 (https://t.co/wbwCwtfZ62) next week.
Kick-off event: agenda available online
Let’s get to work! Next week, RESTORE partners and supporters will officially kick-off RESTORE’s preparatory phase in Berlin. At this...