Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) - Scientific guideline

This document addresses questions on how to demonstrate comparability for gene and cell-based medicinal products following change to the manufacturing process or due to introduction of additional manufacturing sites.

Keywords: Gene therapy medicinal products; cell-therapy and tissue engineering.

Current version

Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)

Reference Number: EMA/CAT/499821/2019 Summary:

This document addresses questions on how to demonstrate comparability for gene and cell-based medicinal products following change to the manufacturing process or due to introduction of additional manufacturing sites.