Abstract
Since its discovery, induced pluripotent stem cell (iPSC) technology has been utilized by researchers seeking to build human-relevant in vitro disease models1. Human iPSC technology has enormous potential for drug discovery, enabling researchers to understand disease mechanisms and screen
potential therapeutics on physiologically relevant cells at scale.
Key to unlocking the full potential of iPSC technology at scale is the establishment of an effective Quality Management System (QMS) to regulate the consistency, purity and functionality of iPSCs and their supporting media and supplements. At Axol Bioscience, we have spent the last decade investing in our quality manufacturing capabilities to create iPSCs under ISO 9001-accredited standards. Our QMS is key to this process, from establishing full donor licensing and consent to characterizing the endpoint cells for use in advanced in vitro models.
Framed by our experience generating over 50 lines at scale (both from healthy control and patient donor material) here we describe our experience establishing standardized reprogramming techniques and quality control checks of pluripotency, genomic stability and karyotyping. With these robust quality systems in place, iPSC reprogramming can be utilized at scale to support a new generation of robust in vitro disease models, to develop better therapies for patients.
