TY - JOUR
T1 - Considerations for the development of iPSC-derived cell therapies
T2 - a review of key challenges by the JSRM-ISCT iPSC Committee
AU - Madrid, Marinna
AU - Lakshmipathy, Uma
AU - Zhang, Xiaokui
AU - Bharti, Kapil
AU - Wall, Dominic M.
AU - Sato, Yoji
AU - Muschler, George
AU - Ting, Anthony
AU - Smith, Nathan
AU - Deguchi, Shuhei
AU - Kawamata, Shin
AU - Moore, Jennifer C.
AU - Makovoz, Bar
AU - Sullivan, Stephen
AU - Falco, Veronica
AU - Al-Riyami, Arwa Z.
N1 - Publisher Copyright:
© 2024 International Society for Cell & Gene Therapy
PY - 2024/11
Y1 - 2024/11
N2 - 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.
AB - 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.
KW - critical quality attributes (CQAs)
KW - good manufacturing practice (cGMP)
KW - iPSC-derived cell therapies
KW - quality by design (QbD)
KW - quality control (QC)
KW - regenerative medicine
KW - the cost of goods (COGs)
UR - https://www.scopus.com/pages/publications/85197458854
U2 - 10.1016/j.jcyt.2024.05.022
DO - 10.1016/j.jcyt.2024.05.022
M3 - Article
AN - SCOPUS:85197458854
SN - 1465-3249
VL - 26
SP - 1382
EP - 1399
JO - Cytotherapy
JF - Cytotherapy
IS - 11
ER -