Working group 2 (WG2) of the Asia Partnership Conference of Regenerative Medicine has discussed eligibility of mesenchymal stromal cells (MSCs) as starting cells for the manufacture of cell therapy products, and comparability before and after changes in their manufacturing process. Asian countries and regions have their own regulations on the quality of starting cells, and these regulations are not harmonized. As cell therapy products are being developed across countries and regions, we propose a risk-based approach based on donor location, window period of virus test, and additional virus tests on the master cell bank to fill the gaps in regulation while controlling the risk of viral contamination. Moreover, a standard procedure of comparability assessment after changes in the manufacturing process of MSC-based products does not exist. The WG2 discussed points of comparability assessment specifically for MSC-based products considering the similarities and differences with parallel assessments for protein and polypeptide products, which are within the scope of the International Council for Harmonization Q5E guideline. We also summarize possible characterization procedures for MSC-based products and report our discussion on stability evaluations under accelerated and stress conditions for comparability assessment of cell therapy products.

亚洲再生医学合作伙伴会议第2工作组（WG2）讨论了间充质基质细胞（MSC）作为生产细胞疗法产品的起始细胞的资格以及其制造工艺改变前后的可比性。亚洲国家和地区对起始细胞的质量有自己的规定，这些规定不统一。随着细胞疗法产品在各个国家和地区的发展，我们提出了一种基于风险的方法，该方法基于供体的位置，病毒测试的窗口期以及对主细胞库的其他病毒测试，以填补监管方面的空白，同时控制风险。病毒污染。而且，不存在基于MSC的产品的制造过程发生变化后进行可比性评估的标准程序。WG2讨论了针对基于MSC的产品的可比性评估要点，考虑了与针对蛋白质和多肽产品的并行评估的异同，这在国际协调委员会Q5E指南的范围内。我们还总结了基于MSC的产品的可能表征过程，并报告了我们在加速和压力条件下进行稳定性评估以进行细胞治疗产品可比性评估的讨论。