Background:
A multivariate formulation robustness study was performed on a selected monoclonal antibody formulation using a custom-designed model. Comprehensive quality testing was performed through a series of stability studies.
Table 1. 5 Formulation Factors at 3 Levels Evaluated in a Customer Design of Experiments
Result:
Statistical analysis was performed using JMP 16 software, which included regression fit models, predictive profile graphs, CPP determination, contour maps and Monte Carlo simulations. The product's critical quality attributes and shelf-life stability met the requirements when formulation compositions were at target and varies within the acceptance ranges.
Figure 1. Predictive Profile Graph of Purity Test for 40℃ 4W Stability
Figure 2. Robustness Diagram Generated Using 4 weeks Stability of Storage at 40℃
(Blue Contour: Acid%, Green Contour: LMW%, Red Box: Acceptance Criteria)
Figure 3. Monte Carlo Simulation Results of 40℃ 4W Stability Study