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(Case study) DoE utilization in biopharmaceutical liquid formulation development (2022-KR-30MP-1244)

Sang-Oh Kwon, CKD Pharm.

 

DoE is a technique currently widely used in drug development. In the development of biopharmaceutical processes, DoE is widely used not only in the development of culture and purification processes to produce biopharmaceuticals, but also in the development of formulations that can stabilize manufactured biopharmaceuticals. The difficulties in applying DoE for optimization in the development of biopharmaceutical liquid formulations are a) that when using a general RSM design, the number of test runs is too large because there are many fixed variables, and b) when conducting stability tests, changes at each time point are required. The point is that the results are accumulating. Therefore, in some cases, additional tests are conducted to reduce variables, or results are interpreted only at specific points rather than all points. However, when using JMP, we were able to solve these difficulties and select an optimized formulation using custom design and flexible DoE analysis. Through JMP's custom design, we were able to create an optimized design that allows testing within a single test set, and by performing analysis of the results with the time point as an additional variable after the DoE design, even changes over time can be interpreted as a single model. There was.Breakout