DoE is a technique currently used universally in pharmaceutical development. In biopharmaceutical process development, DoE is widely used not only for the development of culture processes/purification processes for producing biopharmaceuticals, but also for the development of formulations that can stabilize manufactured biopharmaceuticals. The difficulty in applying DoE for optimization in the development of liquid formulations of biopharmaceuticals is that a) when using general RSM design, there are too many fixed variables, so the number of test runs is too large, and b) when conducting stability tests, the results change at each time point. Therefore, additional tests are conducted to reduce variables, or results are interpreted only at specific points, not all points. However, when utilizing JMP, custom design and flexible DoE analysis were used to resolve these difficulties and select optimized formulations. Through JMP's custom design, an optimization design that allows testing within a single test set was created, and by performing result interpretation with time points as additional variables after DoE design, changes over time were also interpreted as a single model.
