title: cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications.
abstract: The discovery of induced pluripotent stem cells (iPSCs) and the concurrent development of protocols for their cell-type-specific differentiation have revolutionized our approach to cell therapy. It has now become critical to address the challenges related to the generation of iPSCs under current good manufacturing practice (cGMP) compliant conditions, including tissue sourcing, manufacturing, testing, and storage. Furthermore, regarding the technical challenges, it is very important to keep the costs of manufacturing and testing reasonable and solve logistic hurdles that permit the global distribution of these products. Here we describe our efforts to develop a process for the manufacturing of iPSC master cell banks (MCBs) under cGMPs and announce the availability of such banks.
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Behnam Ahmadian
authors.initials: BA
authors.lastname: Baghbaderani
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Xinghui
authors.initials: X
authors.lastname: Tian
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Boon Hwa
authors.initials: BH
authors.lastname: Neo
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Burkall
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Tracy
authors.initials: T
authors.lastname: Dimezzo
authors.affiliation: XCell Science, Inc., Novato, CA 94947 USA.
authors.forename: Guadalupe
authors.initials: G
authors.lastname: Sierra
authors.affiliation: XCell Science, Inc., Novato, CA 94947 USA; Buck Institute for Age Research, Novato, CA 94945, USA.
authors.forename: Xianmin
authors.initials: X
authors.lastname: Zeng
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Kim
authors.initials: K
authors.lastname: Warren
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA.
authors.forename: Don Paul
authors.initials: DP
authors.lastname: Kovarcik
authors.affiliation: Lonza Walkersville, Inc., Walkersville, MD 21793, USA. Electronic address: thomas.fellner@lonza.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Fellner
authors.affiliation: Q Therapeutics, Salt Lake City, UT 84108, USA. Electronic address: rao1789@gmail.com.
authors.forename: Mahendra S
authors.initials: MS
authors.lastname: Rao
mesh_terms: D001709:Biotechnology / Q000379:methods*; D018929:Cell Culture Techniques / Q000379:methods; D002454:Cell Differentiation; D002460:Cell Line; D064987:Cell- and Tissue-Based Therapy; D000067470:Cellular Reprogramming Techniques / Q000379:methods*; D018390:Gene Targeting / Q000379:methods; D006801:Humans; D057026:Induced Pluripotent Stem Cells / Q000166:cytology* / Q000378:metabolism; D033581:Stem Cell Transplantation; D014015:Tissue Banks