Duquesne University's Jim Drennan on PAT Calibration and Innovation

The following is a transcript of Emil Ciurczak's interview at IFPAC 2007 with James Drennan III, Associate Dean of Duquesne University and editor of ISPE’s Journal of Innovation. In this interview, he discusses the new consulting group that he and some colleagues have established, as well as the new journal. To hear the audio file, click the Download Now button below the transcript.

JD: I was approached over 18 months ago by ISPE and they were interested in developing a journal and sought my help with chairing a task force of ISPE members to do that. We kicked that off and spent virtually a year putting together a first issue, which came out in the fall of 2006.

EC: And your publisher is?

JD: The publisher of the first issue was Elsevier. I’m not sure who the new publisher will be, going forward. The goal of the journal is to create a forum for publication in an area that is unique right now compared to other journals out there. We’re looking to provide an opportunity for dialogue in an area that is at the intersection between traditional pharmaceutical sciences and pharmaceutical engineering. And so the task team was made up of a lot of engineers from ISPE and some pharmaceutical scientists. We’ve put together a plan that will let us go forward with a peer-reviewed journal that will allow us to address a lot of critical issues that the industry faces today, working at this interface between engineering and traditional science.

EC: I believe that I’ve already "plagiarized" several of the papers from your first edition in some of my columns. I was struck with the idea that we’re not measuring enough of the physical parameters. We’re only interested in whether something is clean and whether it’s the right chemical, and we do some compendial tests and is it heavy metals that are going to help us make a good tablet. Could you tell me some of the precepts of the papers in your first issue?

JD: We had a variety of papers there, looking at everything from novel software and approaches for product development, to try to speed up pharma product development to new analytical technologies like Terahertz spectroscopy to articles on PAT.

The first issue had a real cross-section of interesting topics. We’ll look for significant variety in the future. I’d imagine us accepting articles on new technologies like nanoparticles and their value in developing new dosage forms, improving drug delivery, gene therapy, and we’ll look for more papers on some of the critical important topics like PAT. So, we’ll let the readers and the industry direct us in identifying critical topics for the journal, but I’d like to keep it focused on the cutting edge of technology.

EC: I notice that you have formed a consulting team with a former professor and former Duquesne student.

JD: About a year ago, we formed Strategic Process Control Technologies LLC with Carl Anderson and former student Dr. Robert Cogdill, who has recently completed his studies at Duquesne in pharmaceutical sciences, and who is now on the faculty at Duquesne University for pharma tech, where he is an industrial research coordinator.

We have a partnership focusing on process control, PAT multivariate data analysis, risk assessment and we’re working to help the industry develop and implement PAT efforts and unique methods for optimizing products and processes. We have some interesting business at this point, and are seeking additional business with the industry, taking advantage of our many years of experience with NIR spectroscopy, chemometrics, data analysis and also pharmaceutics and pharma processing.

EC: Dr. Anderson came from industry and Bob Cogdill had some experience in Europe, if I’m not mistaken, before he came back to complete his Ph.D.

JD: Dr. Anderson’s background is as an analytical chemist. He spent seven years in industry with Aventis. Bob has a background in agricultural engineering and came to Duquesne to complete his Ph.D. in pharma sciences. My background is in pharmacy and pharmaceutical sciences. It’s a good combination that gives us the ability to solve problems well, to provide our clients with some valuable help.

EC: Carl was showing me some of your software, and says you have some unique approaches to chemometrics.and statistics.

JD: Actually, in the last two and a half years we’ve been developing what we call efficient calibration methods. This was actually part of Bob’s Ph.D. work. We found, in the last few years, that as we worked to develop and implement PAT methods with industry, spectroscopic calibration can become a real challenge. With traditional methods, it can require going back to the laboratory and developing essentially out-of-spec product across a wide range of active concentrations as well as excipient concentrations.

It becomes very time-consuming and expensive for the manufacturer who wants to develop an online method of measurement so we through Bob's work have been working on efficient calibration methods which allow us to synthetically create calibration using minimal data. We require raw material spectra, typically, and a very minimal, designed experiment looking at combinations of components and spectra from these materials. In weeks we can create calibrations of identical quality to traditional methods that might require hundreds of samples, months of time and effort to create, not to mention use of valuable active materials and other raw materials that are hard to get in the early development stage.

EC: And of course, it’s frowned on by FDA to make out-of-spec product in a GMP facility so that made it hard for pharma companies to make these samples, too.

JD: The challenge there, Emil, is the fact that no plant manager is going to allow you to go into the manufacturing facility and make OOS material at the plant. That had to be done at the laboratory, and that caused certain challenges in adding lab samples to the calibration. Not insurmountable challenges, but to be able to do this synthetically and use actual product just to validate the calibration is an advance.

EC: So apparently, I have to "steal" a whole set of new slides from you. And of course you’re still cranking out new students, teaching. I was impressed talking to Carl earlier. Thank you for your time. I think people need to hear about all this.