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The OPC (Object Linking Embedding for Process Control) interface is crucial for bioprocess analysis, says Bob Fox, district sales manager at Nova Biomedical, as he comments on the Food and Drug Administration's (FDA's) Process Analytic Technology (PAT) initiative, which promises to bring pharmaceutical into the 21st century through real-time, automated process monitoring and control. PAT will improve process understanding, and, in turn, will lead to more efficient process control, lower process variability, and higher product quality and patient safety. Ajaz S. Hussain of the FDA says the main goal of PAT is to support more stringent science-based manufacturing and to act as a platform for innovation. PAT guidance is intended to relieve any fears in the industry of process innovation. FDA's advisory committee on PAT for biologics is in the process of identifying the areas of bio-manufacturing that will gain the most benefits, and the guidelines concentrate on cultivation of existing analytic abilities. Also commenting are spokespeople for Malvern Process Systems, another spokesman for FDA's Center for Drug Evaluation and Research, Bruker Optics, and Umetrics. Umetrics software components are the engine for such PAT-able analyzers as HPLC, IR, NIR, and cell counters for biotechnology customers that include Novo Nordisk, Novartis, Biogen, and Degussa.
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