Axsun Technologies and GSK Develop Support for
the FDA’s Process Analytical Technology Initiative
BILLERICA, Massachusetts (Sept. 30, 2004) – Axsun Technologies, Inc., a leading manufacturer of micro-optoelectronic products that improve quality, performance, and productivity in a variety of industries, today announced the successful completion of tests at GlaxoSmithKline (GSK) using the Axsun NIR-APS analyzer to analyze core drying functions, an important element in meeting GSK’s commitment to implementing the U.S. Food and Drug Administration’s (FDA) Process Analytical Technology (PAT) initiative.
The goal of the PAT Initiative is to “help manufacturers develop and implement new efficient tools for use during pharmaceutical development, manufacturing, and quality assurance.” As the FDA explains, “Significant opportunities exist for improving the efficiency of pharmaceutical manufacturing and quality assurance through the innovative application of novel product and process development, process controls, and modern process analytical chemistry tools.” Or put simply, “Quality cannot be tested into products; it should be built-in.”
“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, US 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.”
About GlaxoSmithKline
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company with a powerful combination of skills and resources that provides a platform for delivering strong growth in today's rapidly changing healthcare environment. GSK's mission is to improve the quality of human life by enabling people to do more, feel better, and live longer.
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