U.S. Biopharma Manufacturing: Not An Overhead Cost But A Value Center!

By Jeffrey Baker, Ph.D.

Posited: In the year 2021, biopharma manufacturing operations focus on minimizing costs and risks to the timeline, whether that timeline represents speed to market or scheduling a manufacturing campaign.

Posited: In the year 2021, biopharmaceutical development programs and subsequent commercial operations are characterized to the barest levels associated with permission to operate, minimizing development costs and time invested in process understanding.

Posited: Since smart, committed people are working very hard to minimize cost and risk to project timelines, they tend to succeed and subsequently build cultures that engender those successes! These cultures tend to be profoundly risk averse with respect to new technologies or manufacturing paradigms and view questions from regulators, quality units, or even their own process development or manufacturing science staff as “bad” because they are distractions from speed-to-market goals or lot release.