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Toward GMP-compatible derivation of human induced pluripotent stem cells

Thursday, November 07, 2013 — Poster Session II

12:00 p.m. – 2:00 p.m.

FAES Academic Center (Upper-Level Terrace)




  • B.S. Mallon
  • Y. Shi
  • S. Civini
  • M. Sabatino
  • D. Stroncek
  • P.G. Robey


One of the major obstacles in translating human induced pluripotent stem cells (hiPSCs) to clinical applications is in deriving the pluripotent cells in a manner complicit with Good Manufacturing Practice (GMP). To address this, there are 3 major steps to consider: (1) the source material must be derived in a GMP manner, (2) the method of reprogramming must avoid troublesome processes (3) the derivation substrate and media must be GMP-compliant. On campus, the Cell Processing Section is already obtaining material using GMP standards and so we have been focusing efforts on the xeno-free derivation of iPSC clones and subsequent culture. Some of the issues with reprogramming vectors include integration of the reprogramming factors or possibly the use of certain viral vectors. We have tested non-integrating Cytotuneâ„¢ (Life Technologies) Sendai virus mediated and miRNA/mRNA (Stemgent) transduction using several xeno-free media and substrates including Laminin-521 (BioLamina) and Synthemax II (Corning). Initial findings are good and these protocols look promising for future adaptation to GMP protocols.

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