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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., Highlights • Regulations in Cell therapy and Regenerative medicine (WG2 white paper). • A risk-based approach for starting cells to fill gaps in regulation. • Controlling the risk of viral contamination for global development. • Characterization of MSC-based products for comparability assessment. • Stability of MSC-based products under accelerated and stress conditions.

Resumen Introduccion La pandemia por COVID-19 ha conllevado la suspension de la actividad programada en la mayoria de las Unidades de Endoscopia de nuestro medio. El objetivo del presente documento es facilitar el reinicio de la actividad endoscopica electiva de forma eficiente y segura. Material y metodos Se formulo una serie de preguntas consideradas de relevancia clinica y logistica. Para la elaboracion de las respuestas, se realizo una busqueda bibliografica estructurada en las principales bases de datos y se revisaron las recomendaciones de las principales instituciones de Salud Publica y de endoscopia digestiva. Las recomendaciones finales se consensuaron por via telematica. Resultados Se han elaborado un total de 33 recomendaciones. Los principales aspectos que se discuten son: 1) la reevaluacion y priorizacion de la indicacion; 2) la restructuracion de espacios, agendas y del personal sanitario; 3) el cribado de la infeccion, y 4) las medidas de higiene y los equipos de proteccion individual. Conclusion La AEG y la SEED recomiendan reiniciar la actividad endoscopica de forma escalonada, segura, adaptada a los recursos locales y a la situacion epidemiologica de la infeccion por SARS-CoV-2.