Quality and Regulatory Requirements for the Manufacture of Master Cell Banks of Clinical Grade iPSCs: The EU and USA Perspectives

被引:0
作者
Martins, Fernando [1 ,2 ]
Ribeiro, Maria H. L. [1 ,3 ]
机构
[1] Univ Lisbon, Fac Pharm, Ave Prof Gama Pinto, P-1649003 Lisbon, Portugal
[2] Stemamatters SA, P-4805017 Guimaraes, Portugal
[3] Univ Lisbon, Res Inst Med i Med ULisboa, Fac Pharm, Ave Prof Gama Pinto, P-1649003 Lisbon, Portugal
关键词
Induced pluripotent stem cells; iPSCs; Master cell banks; Quality requirements; Regulatory requirements; Manufacture; Clinical grade; PLURIPOTENT STEM-CELLS; MECHANISMS; HISTORY;
D O I
10.1007/s12015-024-10838-9
中图分类号
Q813 [细胞工程];
学科分类号
摘要
The discovery of induced pluripotent stem cells (iPSCs) and protocols for their differentiation into various cell types have revolutionized the field of tissue engineering and regenerative medicine. Developing manufacturing guidelines for safe and GMP-compliant final products has become essential. Allogeneic iPSCs-derived cell therapies are now the preferred manufacturing alternative. This option requires the establishment of clinical-grade master cell banks of iPSCs. This study aimed at reviewing the Quality and Regulatory requirements from the two main authorities in the world-Europe (EMA) and the United States (FDA)-regarding the manufacture of clinical grade master cell banks (iPSCs). The minimum requirements for iPSCs to be used in first-in-human clinical trials were also reviewed, as well as current best practices currently followed by iPSC bank manufacturers for final product characterisation. The methodology used for this work was a review of various sources of information ranging from scientific literature, published guidance documents available on the EMA and FDA websites, GMP and ICH guidelines, and applicable compendial monographs. Manufacturers of iPSCs cell banks looking to qualify them for clinical use are turning to the ICH guidelines and trying to adapt their requirements. Specifically with the impact of the field of iPSC cell banks, the following areas should be subject to guidance and harmonisation: i) expression vectors authorized for iPSC generation; ii) minimum identity testing; iii) minimum purity testing (including adventitious agent testing); and iv) stability testing. Current ICH guidelines for biotechnological/biological products should be extended to cover cell banks used for cell therapies.
引用
收藏
页码:645 / 679
页数:35
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