iPS的EB球形成In 2006 Japanese researcher Shinya Yamanaka discovered 4 genes (now known as Yamanaka factors) that can revert somatic cells back into their pluripotent state. These induced pluripotent stem cells hold the potential to revolutionise the fields of drug discovery, personalised medicine, disease modelling and regenerative medicine and have attracted attention from many pharmaceutical and biotechnology companies. However, a hurdle that still stands in the way of widespread utilisation of iPSC's is the difficulty and time required to produce them in the massive quantities required for research and therapeutic applications. The ABLE Biott bioreactor provides a low cost, scalable solution to this problem with its disposable continuous stirred tank reactor design. The unique delta impeller design found on the ABLE Biott allows the suspension of cells to form more biologically relevant spheroid clusters within the medium, providing yet another benefit when compared to traditional iPSC culturing techniques.
iPS的质控放行在发布 iPSC 储存之前，确认了对微生物（无菌）、支原体、内毒素和人类病毒（包括 HBV、HCV、HIV HTLV 和细小病毒 B19）的阴性测试，以及形态学、HLA 基因分型和 STR 分析。此外，还进行了参考测试以获得良好的克隆选择。这些测试包括增殖能力、解冻后活力和细胞计数（NucleoCounter NC-200)、多能性标记、核型分析、单核苷酸突变/插入缺失突变 (SNV/Indel) 和 (拷贝数变异 (CNV) 分析，这些分析与癌症相关数据库（Catalogue of Somatic Mutation in Cancer (COSMIC) Cancer Gene Census (Sondka et al., 2018) 和 Shibata List (http://www.pmda.go.jp/files/000152599.pdf)）和克隆结构分析。在运送 iPSC 库存时，会提供一份分析证书，其中包含每个 iPSC 库存细胞系的捐赠者信息和测试结果的详细信息。
