Skeptics underestimate the potential of quality by design. But when you look at it as a means toward improving product and process development (PPD), as McKinsey does, QbD becomes a lot more compelling. Even to executives.
PPD "directly determines" production costs before and after commercial launch, write Ted Fuhr, Michele Holcomb and Paul Rutten in Pharma QbD. They estimate that improving PPD can increase an individual compound's lifetime value by 30 to 50 percent--a real executive-enticer--thanks to a drop in manufacturing defects, cycle time, compliance cost and commercialization cost, coupled with a yield increase.
Pharma's failure to realize these benefits is due in part to its practice of transferring clinical trial compound-production methods to commercial manufacturing. Processes developed in the course of speeding a compound from one trial phase to the next are rarely well suited to mass production.
Yet the suboptimal process often becomes the commercial process, thanks to a failure to plan for optimization as part life-cycle management, they write. Management might want to reconsider: McKinsey models suggest that ineffective PPD is costing them as much as 20 percent of potential net profits.
- here's the article (PDF)