TY - JOUR
T1 - Efficient and scalable expansion of human pluripotent stem cells under clinically compliant settings
T2 - A view in 2013
AU - Wang, Ying
AU - Cheng, Linzhao
AU - Gerecht, Sharon
PY - 2014/7
Y1 - 2014/7
N2 - Human pluripotent stem cells (hPSCs) hold great promise for revolutionizing regenerative medicine for their potential applications in disease modeling, drug discovery, and cellular therapy. Many their applications require robust and scalable expansion of hPSCs, even under settings compliant to good clinical practices. Rapid evolution of media and substrates provided safer and more defined culture conditions for long-term expansion of undifferentiated hPSCs in either adhesion or suspension. With well-designed automatic systems or fully controlled bioreactors, production of a clinically relevant quantity of hPSCs could be achieved in the near future. The goal is to find a scalable, xeno-free, chemically defined, and economic culture system for clinical-grade expansion of hPSCs that complies the requirements of current good manufacturing practices. This review provides an updated overview of the current development and challenges on the way to accomplish this goal, including discussions on basic principles for bioprocess design, serum-free media, extracellular matric or synthesized substrate, microcarrier- or cell aggregate-based suspension culture, and scalability and practicality of equipment.
AB - Human pluripotent stem cells (hPSCs) hold great promise for revolutionizing regenerative medicine for their potential applications in disease modeling, drug discovery, and cellular therapy. Many their applications require robust and scalable expansion of hPSCs, even under settings compliant to good clinical practices. Rapid evolution of media and substrates provided safer and more defined culture conditions for long-term expansion of undifferentiated hPSCs in either adhesion or suspension. With well-designed automatic systems or fully controlled bioreactors, production of a clinically relevant quantity of hPSCs could be achieved in the near future. The goal is to find a scalable, xeno-free, chemically defined, and economic culture system for clinical-grade expansion of hPSCs that complies the requirements of current good manufacturing practices. This review provides an updated overview of the current development and challenges on the way to accomplish this goal, including discussions on basic principles for bioprocess design, serum-free media, extracellular matric or synthesized substrate, microcarrier- or cell aggregate-based suspension culture, and scalability and practicality of equipment.
KW - Cellular therapy
KW - Clinical trials
KW - Human pluripotent stem cells
KW - Large-scale expansion
UR - http://www.scopus.com/inward/record.url?scp=84904200925&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84904200925&partnerID=8YFLogxK
U2 - 10.1007/s10439-013-0921-4
DO - 10.1007/s10439-013-0921-4
M3 - Article
C2 - 24132657
AN - SCOPUS:84904200925
SN - 0090-6964
VL - 42
SP - 1357
EP - 1372
JO - Annals of biomedical engineering
JF - Annals of biomedical engineering
IS - 7
ER -