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 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.
Trial and error. That’s one way to discover which molecules to use to create a new plasticizer with specific qualities. But it has its limits. It doesn’t do the best job of putting accumulated knowledge to good use as there are usually only a few people with the right knowledge and experience to contribute to development. A leading producer of specialty chemicals used the Umetrics Suite™ as part of a new tool and a new way of working with the aim of streamlining their work through better use of information – and saving time and resources