For therapeutic proteins and monoclonal antibody- (mAb) based medicines, CMC requirements are well established. And more importantly developers ...
https://www.google.com/url?rct=j&sa=t&url=https://www.genengnews.com/topics/bioprocessing/cell-and-gene-therapy-sector-needs-cmc-clarity/&ct=ga&cd=CAIyGjg0YzkwMzEwZTQwYzQxNjA6Y29tOmVuOlVT&usg=AFQjCNH8OPmc6jOGc0To2Q8OyhHBu-Sokg
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