Kallur Therése, Blomberg Pontus, Stenfelt Sonya, Tryggvason Kristian, Hovatta Outi
BioLamina, Stockholm, Sweden.
Vecura, Karolinska University Hospital, Stockholm, Sweden.
Methods Mol Biol. 2017;1590:11-16. doi: 10.1007/978-1-4939-6921-0_2.
For quality assurance (QA) in stem cell banking, a planned system is needed to ensure that the banked products, stem cells, meet the standards required for research, clinical use, and commercial biotechnological applications. QA is process oriented, avoids, or minimizes unacceptable product defects, and particularly encompasses the management and operational systems of the bank, as well as the ethical and legal frameworks. Quality control (QC ) is product oriented and therefore ensures the stem cells of a bank are what they are expected to be. Testing is for controlling, not assuring, product quality, and is therefore a part of QC , not QA. Like QA, QC is essential for banking cells for quality research and translational application (Schwartz et al., Lancet 379:713-720, 2012). Human embryonic stem cells (hESCs), as cells derived from donated supernumerary embryos from in vitro fertilization (IVF) therapy, are different from other stem cell types in resulting from an embryo that has had two donors . This imposes important ethical and legal constraints on the utility of the cells, which, together with quite specific culture conditions, require special attention in the QA system. Importantly, although the origin and derivation of induced pluripotent stem cells (iPSCs ) differ from that of hESCs, many of the principles of QA for hESC banking are applicable to iPSC banking (Stacey et al., Cell Stem Cell 13:385-388, 2013). Furthermore, despite differences between the legal and regulatory frameworks for hESC and iPSC banking between different countries, the requirements for QA are being harmonized (Stacey et al., Cell Stem Cell 13:385-388, 2013; International Stem Cell Banking Initiative, Stem Cell Rev 5:301-314, 2009).
对于干细胞库的质量保证（QA），需要一个规划好的系统来确保储存的产品，即干细胞，符合研究、临床应用和商业生物技术应用所需的标准。质量保证以过程为导向，避免或尽量减少不可接受的产品缺陷，特别包括库的管理和操作系统，以及伦理和法律框架。质量控制（QC）以产品为导向，因此确保库中的干细胞符合预期。检测是为了控制而非保证产品质量，因此是质量控制的一部分，而非质量保证的一部分。与质量保证一样，质量控制对于储存用于高质量研究和转化应用的细胞至关重要（施瓦茨等人，《柳叶刀》379:713 - 720，2012）。人类胚胎干细胞（hESC）作为从体外受精（IVF）治疗中捐赠的多余胚胎中获取的细胞，与其他干细胞类型不同，因为其来源的胚胎有两个供体。这对细胞的使用施加了重要的伦理和法律限制，再加上相当特殊的培养条件，在质量保证体系中需要特别关注。重要的是，尽管诱导多能干细胞（iPSC）的来源和衍生与hESC不同，但hESC库质量保证的许多原则也适用于iPSC库（斯泰西等人，《细胞干细胞》13:385 - 388，2013）。此外，尽管不同国家之间hESC和iPSC库的法律和监管框架存在差异，但质量保证的要求正在趋于统一（斯泰西等人，《细胞干细胞》13:385 - 388，2013；国际干细胞库倡议组织，《干细胞综述》5:301 - 314，2009）。
