神戸大学附属図書館デジタルアーカイブ
https://hdl.handle.net/20.500.14094/0100491880

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メタデータID
0100491880
アクセス権
open access
出版タイプ
Version of Record
タイトル
Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee
著者
Madrid, Marinna ; Lakshmipathy, Uma ; Zhang, Xiaokui ; Bharti, Kapil ; Wall, Dominic M. ; Sato, Yoji ; Muschler, George ; Ting, Anthony ; Smith, Nathan ; Deguchi, Shuhei ; Kawamata, Shin ; Moore, Jennifer C. ; Makovoz, Bar ; Sullivan, Stephen ; Falco, Veronica ; Al-Riyami, Arwa Z.
著者名
Madrid, Marinna
著者名
Lakshmipathy, Uma
著者名
Zhang, Xiaokui
著者名
Bharti, Kapil
著者名
Wall, Dominic M.
著者名
Sato, Yoji
著者名
Muschler, George
著者名
Ting, Anthony
著者名
Smith, Nathan
著者名
Deguchi, Shuhei
著者ID
A3480
研究者ID
1000000360842
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail.html?systemId=83cb7e6f8a81b25e520e17560c007669
著者名
Kawamata, Shin
川真田, 伸
カワマタ, シン
所属機関名
科学技術イノベーション研究科
著者名
Moore, Jennifer C.
著者名
Makovoz, Bar
著者名
Sullivan, Stephen
著者名
Falco, Veronica
著者名
Al-Riyami, Arwa Z.
言語
English (英語)
収録物名
Cytotherapy
巻(号)
26(11)
ページ
1382-1399
出版者
Elsevier
刊行日
2024-11
公開日
2024-11-01
抄録
Since their first production in 2007, human induced pluripotent stem cells (iPSCs) have provided a novel platform for the development of various cell therapies targeting a spectrum of diseases, ranging from rare genetic eye disorders to cancer treatment. However, several challenges must be tackled for iPSC-based cell therapy to enter the market and achieve broader global adoption. This white paper, authored by the Japanese Society for Regenerative Medicine (JSRM) - International Society for Cell Therapy (ISCT) iPSC Committee delves into the hurdles encountered in the pursuit of safe and economically viable iPSC-based therapies, particularly from the standpoint of the cell therapy industry. It discusses differences in global guidelines and regulatory frameworks, outlines a series of quality control tests required to ensure the safety of the cell therapy, and provides details and important considerations around cost of goods (COGs), including the impact of automated advanced manufacturing.
キーワード
regenerative medicine
iPSC-derived cell therapies
the cost of goods (COGs)
quality by design (QbD)
critical quality attributes (CQAs)
good manufacturing practice (cGMP)
quality control (QC)
カテゴリ
科学技術イノベーション研究科
学術雑誌論文
権利
© 2024 International Society for Cell & Gene Therapy. Published by Elsevier Inc.
CC license
This is an open access article under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International license
関連情報
DOI
https://doi.org/10.1016/j.jcyt.2024.05.022
PMID
38958627