For pharmaceutical and biopharmaceutical manufacturers, scaling up production has typically meant large, 5000+ liter stainless steel bioreactors for the process. These require cleaning and sterilization between batches. Market demands are driving the need for more flexibility with smaller batches. Single-use technologies (SUT) are being applied to bioreactors to address these demands and reduce the cost […]
One of the inherent challenges in top-down scheduling systems, such as manufacturing plans generated from Enterprise Resource Planning (ERP) systems (Level 4 in ANSI/ISA-95 model), are that they are typically based on the ideal state of manufacturers’ processes. The real state may quite different and include issues with equipment, processing steps that didn’t go as […]
The Interphex conference for pharmaceutical and biotech manufacturers is underway this week in New York City. Emerson’s Bob Lenich is presenting Big Data in Life Sciences Manufacturing. Bob opens citing one pharmaceutical manufacturer who generates 5000 data points every second during a production run. This data rate translates into 1.3*1010 pieces of data per production […]
The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps: Discovery and development Preclinical research Clinical trials FDA review FDA post-market safety monitoring I caught up with Emerson’s Zuwei Jin whom you may recall from earlier posts on the role of automation in the drug development process. Zuwei explained to […]
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