Ardena has market leading crystallization process development capabilities. Our team is focused on creating crystal forms that provide our customers with highly detailed information about their drug substances.
Our approach is to develop crystallization processes in parallel with manufacturing processes to optimise yield, flowability, particle size and/or bulk density, and facilitate downstream processing and formulation.
Early in the program, we will prioritise the development of the final purification stages, including the final crystallization process. This is because these steps are more likely to have a high impact on the drug substance impurity profile and other critical quality attributes such as solid state properties.
A well-designed crystallization programme provides full control over your drug substance bulk properties. For early stage compounds, we can set up small scale crystallization screening experiments.