PAT, QbD, and the ISA

The Process Analytical Technology (PAT) guidance from the FDA has been out for several years now. And the concepts of Quality by Design (QbD) are certainly nothing new. Interestingly, some of the references associated with the rollout of PAT had to do with the marked differences in fundamental process understanding between the pharma/biotech world and the rest of manufacturing.

I’ve taken a keen interest in all things PAT related (I’ve written about this before), because I truly believe we folks in the automation industry can provide the technological muscle, hard and soft, for the pharma and biotech industries.

So I was really pleased by the cover story of the March issue of InTech magazine from the ISA titled “If you build it in …”

http://isa.org/InTechTemplate.cfm?template=/ContentManagement/ContentDisplay.cfm&ContentID=74790

It brought into the mainstream of process control and automation the challenges and potential rewards of PAT in providing better process understanding. This understanding translates into increased yields, shorter production cycles, less “bad batches”, and ultimately, lower manufacturing costs.

And I guess there’s somewhat of the proud grandfather complex in me (thanks, Larry Wolfe), but checkout the section in the article labeled “Real-time quality by design” and Talecris Biotherapeutics in Clayton, NC. The water system monitoring and control described was our first DeltaV installation at Talecris and has been one of early PAT wins by any company in the industry. While some of the innovative principles have moved on (Joydeep Ganguly is now at Biogen Idec and Gerrit Vogel is back in the Bayer family), Phil Culberson continues to drive innovation at Talecris as they expand the PAT and QbD concepts, leveraged by their use of DeltaV.