Prime Time Batch Analytics

I mentioned last week that I was helping out at the Emerson Exchange during the technology exhibits for DeltaV Batch. And while we had good traffic from customers (despite my tag as a booth babe), the two areas on either side of us were packed. To the left was the Syncade area where folks were 2 and 3 deep waiting to get a chance to see both the current offerings and soon to be released version 5.3.

To the right was the Advanced Control area, and specifically, the Batch Analytics tool. Emerson announced during Exchange that Batch Analytics will be part of the version 12 release of DeltaV. Coupled with its PAT implications, Batch Analytics promises to be a game changer in the batch process control world.

I’ve been following the development of the Batch Analytics tool for almost 4 years now. And while the discussions about its PCA, PLS, and Dynamic Time Warping components are better left to Terry Blevins, David Rehbein, and Chris Worek, I feel I’m qualified to talk about the Batch Analytics interface app for the iPad.

It is so cool! Paul Muston from Emerson in England did the development work and I nagged enough folks to get the first version installed on my iPod Touch, and then the enhanced iPad compatible app this past May (to be fair, I bought the iPad as a mother’s day present to my wife – she proceeded to get me diamond studded earrings for father’s day).

Below you’ll find some iPad screenshots of the fault detection, endpoint quality, and contribution screens. I’ve also posted a video on my YouTube channel showing the iPhone version running on my iPad.

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!

FDA sponsored PAT Conference

The FDA and the University of Rhode Island are sponsoring a two day Conference entitled “FDA and PAT for Pharma Manufacturing FDA-Partnering with Industry”. It’s being held on May 11th and 12th at the Hyatt Regency in Bethesda, MD.  It's part of the FDA's 2010 Conference Series.

Besides my buddy Terry Blevins from Emerson, there are 16 other speakers from both industry and the FDA. You can use this link to get to a PDF with all the important info, including another link to register.

Lobbying will start immediately to secure my attendance.

Transitional Analysis and PAT

I was with a customer last week and I was going over my Transitional Analysis application. As I described it in more detail – its ability to non-obtrusively measure chromatography column viability prior to applying product – the customer got more and more animated. Finally, he looked at me and said “Why, that’s PAT!”

So check out www.transitionalanalysis.net for more information about the application. And by the way, the customer I was talking to doesn’t have a DeltaV system. He does have a bunch of chromatography skids with proprietary (vendor supplied) method controls. The TA application is platform agnostic.

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.

Technology Forum in RTP

On October 3rd and 4th, we hosted our first Carolinas Life Science Technology Forum at the Sheraton Imperial in RTP.

We had a great turnout and even hosted an open house at the RE Mason RTP office Wednesday evening. Over 20 workshops were held and one of the highlights was a talk from Joydeep Ganguly of Biogen Idec entitled “PAT from a Users Perspective”.