As seen the documents of Process validation in the registration dossier, if what Ms. Mira referred is same as attached, would you please ask for the process validation protocol and report of each monovalent bulk.
Because the attached looks like the summary.
For the Manufacturing process development, can you please ask Ms. Mira to add the key important development steps of the technology of Japan government too (From Japan government as understood that BF has not yet conduct any developments