Reference Materials for Quality Control of Pluripotent Stem Cell-Derived Products

Zhao Xiang^1#, Zhang Zhenhua^1#, Wang Jian¹, Zeng Tai¹, Yang Xiang¹, Cao Yuhao¹, Lu Zhongzhou², Lu Min^1*

¹Zhejiang Gene Stem Cell Biotech Co., Ltd, Huzhou 313000 China; ²Biochemistry and Molecular Biology Department of Eberly College of Science of Pennsylvania State University, PA 16801, USA

Abstract: Currently， the clinical use of human pluripotent stem cell-derived products (hPSC-derived products) suffers from lacking of reproducibility and consistency， which further impedes the research and clinical translation of such products. Thus， it becomes more necessary for the use of reference materials to ensure the reproducibility and consistency of hPSC-derived products and to identify the drift of process and method over time. Due to the challenge to achieve consensual reference materials， we firstly focused on in-house reference materials. Hereby we outlined the importance of reference materials to hPSC-derived products， assessed the approaches to generate in-house reference materials and discussed the potential routes to achieve reference materials， which might provide valuable tools to measure and interpret the drift of process and method over time.

CSTR: 32200.14.cjcb.2015.12.0013