Allele Discloses How its Highly Efficient iPSC Culturing is Conducted Under cGMP

In their latest paper published in the online prepublication by the peer-reviewed journal Current Protocols, scientists and cGMP operation managers at Allele Biotechnology present a series of step-by-step protocols for manufacturers of iPSC (induced pluripotent stem cells) and other types of stem cells with streamlined cleanroom practices for growing clinical grade cell products. Additionally, in the open access version of the paper, Rivera et al. provide sources of cGMP-grade culture media, key reagents, equipment as well as the critical steps taken during splitting, stocking, and thawing of frozen iPSC stocks.

This is the continuation of a series of protocol publications in the same journal, where Allele has provided procedures for mRNA reprogramming and generating iPSCs using cGMP materials. Five years after establishing Allele's own iPSC-dedicated cGMP facility and with three years of actual production, the knowledge obtained has been distilled into the most recent publication describing the key elements critical to successful pluripotent stem cell manufacturing for cell and gene therapies.

The mRNA reprogramming technology developed by Allele has proven to be highly efficient, consistent, and reproducible. It allows generation of iPSCs that better recapitulate the molecular signatures of human embryonic stem cells and with faster kinetics than other methods. Differentiation potential of iPSC lines generated using published protocols by Allele have been tested towards more than a dozen different cell types successfully by several teams in the industry with minimal line-to-line variations.

Dr. Jiwu Wang and his coauthors state that "this fully tested protocol for iPSC culture has been optimized for efficient iPSC proliferation and stemness. It allows scalable manufacturing operations that are fully compliant with cGMP standards; it can be adopted by any cGMP facility, providing a valuable platform to generate iPSCs for clinical applications. Moreover, this platform is designed to allow an easy transition to closed cell culture systems towards automation, which facilitates scalability and controllability and reduces operator-introduced variability, a direction of development Allele is actively engaged in."

The paper can be obtained by visiting the Current Protocols website or by searching for the publication's reference: Rivera, T., Zhao, Y., Ni, Y., & Wang, J. (2020). Human-induced pluripotent stem cell culture methods under cGMP conditions. Current Protocols in Stem Cell Biology, 54, e117.