Hot Topic for Emerson Exchange?

I’ve been following a very interesting discussion thread out on LinkedIn. It’s in the Process Analytical Technology group and it’s entitled “Dangling a Carrot: Should PAT Be Mandated, or Incentivized?” The discussion was started by Paul Thomas, Senior Editor at Pharmaceutical Manufacturing, based on comments made back in May at the PAT and QbD Conference in Bethesda.

While I am infinitely under-qualified to comment, I’ve found the opinions on both sides to be quite passionate. And maybe that’ll be the catalyst to finally get some traction going within the Life Sciences community.

I think this could make a great discussion topic in the Life Sciences Industry Forum at the upcoming Emerson Global User Exchange in San Antonio. Gawayne Mahboubian-Jones (the man from Optimal) has been chiming in on the LinkedIn thread and is one of this year’s presenters at Exchange, so this could be a lively discussion.

And if you haven't gone out and looked at the Workshops and Short Courses being offered at this year's Exchange, you should.  I've already highlighted 30 sessions I want to attend, and with presenting one myself (how's that for another shameless plug?), I'm going to have to make some tough choices on how to spend my time.  And you'll also find me in the exhibit hall from 4 to 8 pm in the DeltaV Batch area - I'm a Booth Babe!

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.