Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 17 (i.e., predicting) the currently evolving batch into a process monitoring model to uncover whether this batch conforms to, or deviates from, normal operating conditions. In another aspect, predic- tive analytics may mean an attempt to explain (i.e., predict) final batch critical quality attributes (CQAs), such as peak VCD or titer, in terms of their correlations to batch critical process parameters (CPPs). Irrespective of the connotation of the term, predictive analytics to find out what will happen is conveniently carried out by using tools like DOE, PCA, PLS, and OPLS (2, 3). Prescriptive analytics Prescriptive analytics is the last stage of the data analytics continuum, and, at this stage, focus lies on forecasting the future, either to drive the manufacturing toward an optimal situation or to avoid certain undesirable process hiccups from happening. In general, in real-time applications, the stages of predictive and prescriptive analytics are often intimately linked (4). According to refer- ence 4, "one approach that has become common in biologics manufacturing is the use of multivariate modeling and calibrate models to determine how a process should run. We turn such models into control charts and track a process as it is running." Beyond this real-time monitoring step, model pre- dictive control tools are described, which are avail- able in terms of a real-time bioprocess forecasting, control, and optimization toolbox (4). With this toolbox, "smart changes" (i.e., "advised future") to setpoints of bioprocess CPPs resulting in opti- mized production are given. Conclusion The data analytics continuum is a way to concat- enate the four major steps of data analytics into an Figure 3: Scatter graph arising from a batch-scale comparison model. Each plotted point represents one completed batch. Points that are close to each other correspond to batches of similar process operating conditions. Points that are far away from each other correspond to batches of very different process operating conditions. Symbol color indicates batch scale: blue is micro, red is micro+, and green is pilot. Symbol size indicates final peak viable cell density (VCD). In particular, there is a conspicuous deviation on the micro+ scale for some batches marked by the frame at the top of the graph.

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