Abbasalizadeh Saeed, Pakzad Mohammad, Cabral Joaquim M S, Baharvand Hossein
a Department of Stem Cells and Developmental Biology, Cell Science Research Center , Royan Institute for Stem Cell Biology and Technology, ACECR , Tehran , Iran.
b Department of Bioengineering and Institute for Bioengineering and Biosciences , Instituto Superior Técnico, Universidade de Lisboa , Lisboa , Portugal.
Expert Opin Biol Ther. 2017 Oct;17(10):1201-1219. doi: 10.1080/14712598.2017.1354982. Epub 2017 Jul 20.
Currently, promising outcomes from clinical trials of allogeneic cells, especially allogeneic mesenchymal stromal cells, fibroblasts, keratinocytes, and human cardiac stem cells, have encouraged research institutions, small and medium enterprises (SMEs), and big pharmaceutical companies to invest and focus on developing allogeneic cell therapy products. Commercial and large-scale production of allogeneic cell therapy products requires unique capabilities to develop technologies that generate safe and effective allogeneic cells/cell lines and their fully characterized master/working banks. In addition, it is necessary to design robust upstream and downstream manufacturing processes, and establish integrated, well-designed manufacturing facilities to produce high quality affordable products in accordance with current GMP regulations for the production of cell therapy products. Areas covered: The authors highlight: the recent advances in the development of allogeneic products, the available options to develop robust manufacturing processes, and facility design considerations. Expert opinion: Currently, there are multiple challenges in development of allogeneic cell therapy products. Indeed, the field is still in its infancy; with technologies and regulations still under development, as is our understanding of the mechanisms of action in the body and their interaction with the host immune system. Their characterization and testing is also an emerging and very complex area.
目前，异体细胞临床试验取得的良好成果，尤其是异体间充质基质细胞、成纤维细胞、角质形成细胞和人类心脏干细胞的临床试验成果，促使研究机构、中小企业和大型制药公司投资并专注于开发异体细胞治疗产品。异体细胞治疗产品的商业化和大规模生产需要具备独特能力，以开发能够生成安全有效的异体细胞/细胞系及其经过充分表征的主细胞库/工作细胞库的技术。此外，有必要设计稳健的上游和下游制造工艺，并建立集成化、精心设计的制造设施，以根据当前细胞治疗产品生产的GMP法规生产高质量且价格合理的产品。涵盖领域：作者强调了：异体产品开发的最新进展、开发稳健制造工艺的可用选项以及设施设计考量。专家观点：目前，异体细胞治疗产品的开发存在多重挑战。实际上，该领域仍处于起步阶段；技术和法规仍在发展之中，我们对其在体内的作用机制及其与宿主免疫系统相互作用的理解也是如此。它们的表征和测试也是一个新兴且非常复杂的领域。
