News

Posted On: 10/20/2004

Axsun, GSK Develop Support For FDA's PAT Initiative

Axsun Technologies, Inc., has completed tests at GlaxoSmithKline (GSK) using the Axsun NIR-APS analyzer to analyze core drying functions, an important element in meeting GSK's commitment to implement the Food and Drug Administration's (FDA) Process Analytical Technology (PAT) initiative.

"We have been working with Axsun to develop near-infrared (NIR) monitoring of our drying processes as a part of our PAT initiative support," said James Rydzak, U.S. PAT coordinator for GlaxoSmithKline's Chemical Development Strategic Technologies Division. "In our testing, the Axsun NIR-APS spectrometer has proved that a miniature near-infrared monitoring instrument can be used to ensure high product quality during this important manufacturing process."

Petros Kotidis, Axsun's vice president of marketing and business development, explained, "The FDA's PAT initiative encourages pharmaceutical companies to monitor the drug-manufacturing process to increase efficiency. Our NIR-APS analyzers let pharmaceutical customers evaluate near-infrared PAT capabilities before deploying complete process solutions. Many companies are finding that they can significantly reduce manufacturing time and help ensure quality on an ongoing basis with a small, high-quality near-infrared instrument well-suited to on-line applications."

Dr. Kotidis continued, "We are designing a spectroscopy product specifically for on-line process applications, based on the results of trials with the NIR-APS unit at GSK and other companies."