Dionex Corporation has expanded its emphasis on process monitoring with the creation of the Process Analytics Center of Excellence to realize the advantages of on-line liquid chromatography (LC) analyzers. On-line LC analyzers enable the most widely used analytical technique in the pharmaceutical industry (HPLC) to be moved from the laboratory to the process floor. Moving HPLC to the production area will allow assays currently performed off-line to be directly replicated on-line for process monitoring and control. On-line analysis can enable increases in process capacity, understanding, and containment, and decreases in variability and cycle times. The U.S. Food and Drug Administration's recent initiatives, Process Analytical Technology and GMP's for the 21st Century, have raised awareness of process analyzer technologies and the benefits of continuous process monitoring.
A major focus of the Process Analytics Center of Excellence is to provide solutions for the biotechnology industry, where the resolution and specificity of LC-based process analyzers are well suited for the complexity and variability of these process streams. Examples of how on-line LC analyzers are currently being used in the biotech industry for process monitoring and control are the quantitation of amino acids and glucose in bioreactors; determination of product purity in the eluent stream from process scale chromatography columns; and monitoring the progress of enzyme-mediated reactions.
Former pharmaceutical industry insider Rick Cooley heads the Dionex Process Analytics Center of Excellence. After retiring from Eli Lilly & Company, Mr. Cooley brings valuable new expertise to Dionex. For 25 years, Mr. Cooley was involved in the development, implementation, and support of on-line liquid chromatography-based analyzers used for biotech products of Eli Lilly.