Manufacturability Assessment

Overview

A systematic pre-launch evaluation of biologics manufacturing risks performed by a product technical leader with an operations mindset during the put-to-phase, functioning as an independent check on CMC development to identify and correct issues before commercialization. Manufacturability assessments are distinct from developability assessments in that they evaluate manufacturing process risks at scale — led by someone with an operational manufacturing mindset rather than CMC scientists — and are conducted during the put-to-phase to identify course corrections before launch. Roche's Global MSAT function acts as a natural organizational tension against the CMC development head by providing independent manufacturability risk assessment, creating a checks-and-balances structure that counters the speed bias inherent in technical development. (Segment 5 (20:00-25:00))