PAT Initiative Hogs the Spotlight at IFPAC 2005

Despite a broad conference program, pharmaceutical PAT held the center stage.

By Terrence K. McMahon, McMahon Technology Associates

Held at Washington’s Crystal Gateway Marriott for the second consecutive year (Jan. 10-13), IFPAC/2005, a major conference on instrumentation was dominated by pharmaceuticals conferees and papers. Total attendance surged past the 500 mark, and about 28% of those attending had some connection with the pharmaceutical industry, either as drug manufacturers, FDA regulators, contract services firms or academic or research institutions.

Of the more than 200 papers presented at the conference, close to 20% mentioned Process Analytical Technologies (PAT) in the title. Many others dealt with the substance of the PAT Initiative. The 2006 IFPAC meeting also appears headed for the Nation’s Capitol as a number of Federal agencies, in addition to FDA, are keenly interested in on-stream analysis.

More than a dozen pharmaceutical/biotech manufacturers presented technical papers. Analytical techniques employed included:

  • Process GC, Process MS for gas phase process development and vacuum drying;

  • Process HPLC, FT-IR, NIR and FIA for liquid-phase applications, including reaction monitoring, API measurement and separations;

  • NIR, Raman, Acoustic Emission and EDXRF for solid-phase and dosage forms, including crystallization, compounding, imaging and monitoring of granulation and blending;
as well as a range of chemometric and statitical interpretive methods.

Rick Cooley of Eli Lilly discussed his company’s 24-year history with on-stream HPLC in the context of biotech API processes.

“The types of sensors that we have used span from simple pH and conductivity detectors, through fixed wavelength optical measurements, to on-line HPLC analyzers Although our goal is to utilize simple, rugged measurement technologies whenever possible, the complexity of biotech processes has required us to make use of on-line HPLC as one of our mainstay monitoring technologies.”

Cooley stated that Lilly currently has 30 on-line HPLC analyzers in operation, most within the company’s Indianapolis manufacturing complex. While this technology took years to develop and perfect, HPLC is the only method suitable for these applications, which include the manufacture of biosynthetic human insulin. Biotech manufacturing, in particular, is believed to have a large concentration of potential uses for on-stream HPLC.

Merck and Pfizer discussed the use of on-line Raman spectroscopy for process development in crystallization, while Bristol-Myers Squibb (BMS) discussed the technology’s use in dosage form monitoring -- specifically, in tablet coating and blend uniformity.

Dr. T.D. Stevens from BMS reviewed the development, implementation and assessment of a project to apply on-stream NIR monitoring to a Glatt 500 Fluid Bed Dryer including:

  • Instrument Selection/Feasibility Analysis
  • Chemometric Modeling
  • Mechanical Installation/Data Collection
  • Software/Hardware System Integration
  • Process Control, Product Release Strategy Development
  • Long-term Performance
After nearly half a million kilograms of product throughput, the NIR instrumentation and chemometric model has been shown not only to be robust in a manufacturing environment but also to be more reliable and repeatable than the traditional LOD (Loss on Drying) release method.

For further information, contact IFPAC Executive Director Robert Zutkis (ifpac@ais.com).

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