(1135-D) Establishment of a quality-driven manufacturing process to reprogram human donor material into human induced pluripotent stem cells to support drug discovery.

Abstract: Since the discovery of technology to reprogram adult cells back into a stem cell state, induced pluripotent stem cell (iPSC) technology has been utilized by researchers seeking to model human disease in an in vitro environment.

Realizing this potential, at an appropriate scale, requires the establishment and implementation of an effective Quality Management System (QMS) that looks to control and understand the consistency, purity, and functionality of iPSCs, as well as supporting media and supplements.

Over the past 10 years, we have established methodologies to manufacture iPSCs under ISO-accredited standards. Our QMS begins with establishing the legal rights to use the donated materials and works through to the functional utility of the derived cells in in vitro models.

With experience in generating over 50 lines, both from healthy and patient donor material, we describe our experience in understanding and managing variability and establishing standardized reprogramming techniques and quality control checks of pluripotency, genomic stability and karyotyping.

With these systems in place, iPSC reprogramming can be realized at a suitable scale and with sufficient quality to support a new generation of credible in vitro models of human disease.