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(Case study) Use of DoE in the development of liquid formulations for biopharmaceuticals (2022-KR-30MP-1244)

Sang-Oh Kwon, CKD Pharm

 

DoE is currently a commonly used technique in drug development. In the development of biopharmaceutical processes, DoE is widely used not only for the development of culture and purification processes that produce biopharmaceuticals, but also for the development of formulations that can stabilize manufactured biopharmaceuticals. Difficulties in applying DoE for optimization in the development of liquid formulations for biopharmaceuticals are a) when using a general RSM design, the number of test runs becomes too large because there are many fixed variables, and b) in the process of stability testing, the number of changes at each time point The thing is, the results are cumulative. Therefore, additional tests may be conducted to reduce variables, or results may be interpreted only at specific points rather than all points. However, when using JMP, it was possible to overcome these difficulties and select an optimized formulation by using custom design and flexible DoE analysis. Through JMP's custom design, it was possible to design an optimization that allows testing within a single test set, and by performing result analysis with the time point as an additional variable after DoE design, it is possible to analyze changes over time as a single model. there wasBreakout