Scientists and cGMP operation managers at Allele Biotechnology have presented a series of step-by-step protocols for manufacturers of iPSC and other types of stem cells with streamlined cleanroom practices for growing clinical-grade cell products
Allele Biotechnology has published its latest paper in the September 2020 issue of the Current Protocols journal. This is notable because many therapeutics developers and manufacturers are struggling to establish the best methods to culture, examine, and store clinical-grade iPSCs using reagents, materials, and equipment that are compliant with cGMP standards.
This paper provides a high degree of detail about the methods and materials we have been successfully using in our own facility for several years.
In the latest paper published in the September 2020 edition of 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.
This fully tested protocol for iPSC culture has been optimised for efficient iPSC proliferation and stemness
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 its own 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: "This fully tested protocol for iPSC culture has been optimised 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."