Workhorse analytical tools to reduce human errors
to co-market measuring solutions for the pharmaceutical industry,
as the Process Analytical Technology (PAT) initiative gains
popularity among drug manufacturers constantly looking for ways to
improve processing efficiencies and costs.
The marketing activities have brought together Groton's automated reactor sampling system (ARS) and Agilent's 1200 LC for online High Performance Liquid Chromatography (HPLC). The analytical system is connected directly to the production process bioreactor eliminating the need for manual sampling and delivery to an off-site analytical laboratory. The system provides real time data on the manufacturing process parameters and allows quick process adjustments to increase yield and high quality products, said contract manufacturers Agilent and Groton.
"HPLC is a workhorse analytical tool in the pharma and biotechnology industry. The ability to bring the Agilent 1200 series LC closer to the production process providing near real time data has been desperately needed and requested by many of the major companies and is in alignment with the FDA's PAT initiative," Michael Kraft, product marketing manager at Agilent, told In-PharmaTechnologist.com.
"The pharma industry executives are pressured to reduce the cost of drugs while at the same time ensuring the highest possible level of quality. This online HPLC solution with the Agilent 1200 series LC reduces the amount of expensive manual labour in the development and manufacturing process along with eliminating the chance of human error."
Agilent and Groton said that their combination technology would make it possible to increase sample frequency, which is supported by the PAT initiative, and to eliminate time-consuming manual sampling, sample preparation and analysis, thus reducing cost.
Agilent's revenues for the fiscal year 2006 were $5bn (€3.85bn) and the company employs around 19,000 people serving customers in over 100 countries. Groton Biosystems, a subsidiary of Groton Technologies, has an in-house 14,0000 square foot manufacturing facility based in Boxborough, Massachusetts.