Hoffman-Roche Uses DOE to Demonstrate Antibody Formula Robustness
Using MODDE for design of experiments
This quality-by-design example case shows how a multivariate study can be used to successfully predict formulation robustness of a biopharmaceutical product with a specified shelf life.
Using the Umetrics Suite, scientists at Hoffmann-Roche were able to create a design of experiment (DOE) study to predict antibody formula robustness using regression models that were both statistically significant and produced parameters for predicting the acceptable limits of robustness for the formula over time.
As a result, the company:
- created a reliable quality-by-design process that meets the International Conference on Harmonization Q8 (ICHQ8) standards for assessing the robustness of a formulation
- could predict the critical quality attributes for a 36-month shelf life using less than 24 months of data.
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