Formulation robustness studies
We make sure that your formulation is ready for manufacturing.
To reproducibly obtain a high-quality drug product with the desired shelf-life, the formulation needs to be robust towards potential variations in certain process parameters, such as solution pH, excipient concentrations or primary packaging.
Coriolis has many years of experience in performing formulation robustness studies, employing carefully selected analytical methods to test potential critical quality attributes (pCQA) at real time and under accelerated stress. This enables us to scientifically define process specifications for manufacturing a biopharmaceutical drug product in late development phases.
Contact our experts today to find out how to design a formulation robustness study that supports your drug development strategy.