PITTCON Preview: Mini Spectrometer Symposium, Plenty of PAT

01/26/2005

Orlando’s PITTCON 2005, February 27 to March 4, will offer more than enough for PAT aficionados. A few symposia of note:

• “PAT for Biopharmaceuticals: Analytical Technologies for Real Time Biological Process Monitoring” (Wednesday morning, March 2): Xcellerex’s Elizabeth Fowler hosts the discussion and will present. She’ll be followed by a contingent from Pfizer speaking on a high-throughput platform for monoclonal antibodies. Don Strauss of Genomic Profiling Systems will present as well, followed by Nicole Denkinger of Boehringer Ingelheim.
  
  
• “Development of Process Analytical Technology Applications—From Design Stage to Implementation” (Wednesday afternoon, March 2): AstraZeneca’s Peter Brush presides over a forum that includes FDA’s Chris Watts, Pfizer’s Andrew Lange and Thomas Garcia, Abbott’s Walter Dziki and Jean-Marie Geoffrey, and others.

Miniature Spectrometers

Richard Crocombe, director of marketing for optical micro-instrumentation at Axsun Technologies, will chair a Thursday afternoon symposium, “Miniature Spectrometers for Process Analytical Chemistry: Towards a Spectroscopic Sensor.”

The symposium will feature Pfizer’s Martin Warman, on-line analysis team leader of the Global Process Analysis Support Group, and GlaxoSmithKline’s James W. Rydzak, investigator, Process Analytical Technology and Chemometrics Group. They will describe process analytical applications for miniature near-infrared spectrometers in both primary (active pharmaceutical ingredient) and secondary (tablet and solid dosage formats) manufacturing. These include ‘unit operations’ like blending and drying, as well as applications for mobile, or ‘point-of-use’ spectrometers.

John Coates, a consultant and long-time champion and developer of micro-spectrometers, will describe a wide variety of applications for specially designed, or targeted, optical spectrometers, using a variety of technologies, and operating from the visible to the mid-infrared region of the spectrum. Mike Doyle, president and CEO of Axiom Analytical, a manufacturer of process probes and interfaces, will discuss the integration of miniature near-infrared spectrometers, probes and real-time chemometric software to produce process spectroscopic sensors. In addition to chairing the session, Crocombe will describe how adaptation of modern telecommunications technology leads to miniature and rugged near-infrared spectrometers with high-power tunable sources, and how these are now being deployed in chemical process analyses.

Spectroscopic Breakthroughs

Over the past 30 years, optical spectrometers have shrunk dramatically in size: from the room-filling behemoths of the 1970s, to benchtop instruments of the 1980s, and portable units in the 1990s. However, until now, the available analytical tools have been too delicate, too big, and too costly to deploy effectively throughout most industrial process lines. A new generation of MEMS-based miniaturized spectrometers has recently emerged, and these new instruments — spectrometers-on-a-chip — can now be mounted directly on a process probe, by-pass loop, or pharmaceutical dryer and blender. This greatly facilitates installation and widespread deployment of process spectrometers, and leads towards their use as dedicated spectroscopic sensors.

These breakthroughs in miniaturized spectroscopic instruments are enabling true process-analytical spectroscopy and will ultimately change pharmaceutical and chemical manufacturing so that quality is designed in as an integral part of the production process — from raw materials through manufacturing, to final packaging. The symposium will provide real-world examples of this new trend in manufacturing, which is being driven both by internal company cost-savings, quality, and productivity-enhancement programs, and regulatory initiatives, such as the U.S. Food and Drug Administration’s (FDA) Process Analytical Technologies (PAT) Initiative.

Updated information on the symposium may be found at: www.axsun.com/html/news_events_pittcon2005.htm.
PITTCON information is available at www.pittcon.org.