IFPAC (International Forum of Process Analytical Technology; Process Analysis and Control) is a deceptive conference. It might seem to be highly niched, and only for the most serious analytics enthusiasts, but many of its presentations cut to the heart of Lean Six Sigma, continuous improvement, quality systems and Quality by Design.
We were fortunate this year to have the event covered by two expert spectroscopists, our esteemed editorial advisors Emil Ciurczak and Gary Ritchie, who videotaped interviews with key figures from FDA, industry, academia and vendor companies, including Pfizer’s Steve Hammond, Dionex’s Rick Cooley, Amgen’s Martin Van Trieste and Infometrix’s Brian Rohrbach.
Here, a brief summary of what our staff experienced:
This year’s program kicked off with a Sunday afternoon FDA Workshop featuring Lawrence Yu, Ph.D. (Office of Generic Drugs, OPS, CDER), Steven Kozlowski, M.D. (Office of Biotechnology Products, OPS, CDER) and Christine Moore, Ph.D. (Office of New Drug Quality Assessment, OPS, CDER). They updated the status of PAT/QbD in their departments and endured a vigorous, hour-long Q&A following in which audience members probed on issues ranging from subpar generics to follow-on biologics.
Biotech found its way into the program as well. On Monday, an entire session was devoted to PAT in bioprocessing, with presentations by university professors and instrument company representatives who, in contrast to leaders of small molecule PAT efforts, seem to be spearheading PAT together. In another track, Anurag Rathmore and Ashutosh Sharma from Amgen discussed the application of PAT and QbD to the biopharma process, outlining the opportunities and challenges.
The session covered the overall process: its potential and challenges; multiple on-line instrumentation and chemometrics, along with the use of proton transfer reaction mass spectrometry (PTR-MS) as a monitor, and laser analyzers to monitor the headspace of bioreactors. An interesting use of Raman to analyze biofuels was presented by Stuart Farquharson of Real-Time Analyzers. (A video of his discussion of on-line pharma applications can be found on PharmaManufacturing.com.)
Attendees were abuzz with conjecture about what the merger of Pfizer and Wyeth would bring. Both companies bring substantial contributions to both PAT and QbD. Steve Hammond, who has led Pfizer’s PAT initiatives for many years, discussed the application of PAT to biopharma in an interview. Wyeth also has robust PAT and QbD programs in place (interviews with PAT leader Pedro Hernandez and QbD guru Steve Simmons are also on our web site.)
Another interesting concept, PQLI (Product Quality Lifecycle Implementation), was unveiled at an ISPE-sponsored session. The first three presentations by consultant Bruce Davis, Stephen Tyler of Abbott and Jean-Sebastien Simard of Wyeth, explained the concept. Following were detailed explorations of the design space by Theodora Kourti of GSK and the U.K.-based consultant Charles Potter.
Interspersed with presentations to the chemical industry were some interesting hardware and methodology talks. A group from GSK and Custom Sensors & Automation shared data generated by light-induced fluorescence (LIF) in a process stream and in the field, while researchers from Rutgers discussed laser-induced breakdown spectroscopy (LIBS) for tablet coating uniformity and endpoint. Pat Faustino from FDA, in cooperation with F.R. Doucet of Canada’s National Research Council and Martine Tourigny of PharmaLaser, shared some interesting work on matrix effects on the signal intensity of a LIBS analysis. We interviewed Stephane Mallett and Dr. Doucet of PharmaLaser on this work. In another paper, Doucet discussed determination of physical properties with LIBS.
Spectroscopy, naturally, was one of the central themes of PAT/QbD. Discussions ranged from time-domain Terahertz measurements in on- and off-line measurements of variation. In an interview, Mark Kemper of Picometrix explained the theory of TD-THz.
An entire session was devoted to chemometrics — no surprise, since all the disparate signals generated by an NIR-based PAT system must be interpreted and correlated. An excellent overview was given by Brian Rohrbach of Infometrix, who discussed with us the problems of integrating signals (spectra, etc.) and making meaningful chemometric equations in a video interview.
Optimal chemometric approaches for counterfeit products were discussed by T.W. Brueggemeyer of FDA, while statistics and statistical process monitoring (SPM) were covered by Nouna Kattanah and Svante Wold, founder of Umetrics and winner of numerous awards for his work in the field. Chemometrics was covered in the context of QbD program development by Louis Halvorsen of Northwest Analytical, while Gregory Banik of Bio-Rad expanded the topic to cover global databases. This is important in light of the wide range of suppliers to any multinational pharmaceutical company; QbD aims for quality, reproducible product, so tight control of raw materials and intermediates is critical.
Another methodology worth mentioning is chemical imaging (CI), to which a whole session was devoted. Steve Hammond discussed the business advantages of CI. Janie Dubois of Malvern Instruments showed data on applying the technique to troubleshoot dissolution failures, while Eli Margalith of Opotek discussed hyperspectral imaging using a tunable laser. Brueggemeyer and FDA colleagues showed how CI might be used to categorize excipient formulations in counterfeit products.
Eunah Lee of Horiba Jobin Yvon showed ways to improve imaging, while University of Tennessee professor Frank Vogt discussed spectroscopic analysis of biological materials. Neil Lewis of Malvern spoke about applications for Raman microscopy. The session closed with Phil Taday of TeraView speaking about pulsed terahertz in pharmaceuticals.
Emil and Gary recommend that any company planning to attend IFPAC in the future send more than one person, just to cover the broad range of topics and papers presented.
