Early Stage Development
Solid State Pharma is prepared to engineer and develop a robust process for your early phase API that ensures the correct polymorph is isolated as a flowable solid. Our scientists are experienced in efficiently resolving crystallization challenges such as oiling out, gumming, filtration, drying, impurity purging, particle size and morphology control, minimizing residual solvent, maximizing yield, and many other parameters to meet our client’s specifications. This can range from developing a novel process to troubleshooting or building upon an existing process.
Solid State Pharma is also equipped to conduct Design of Experiment (DOE) studies utilizing Design-Expert software and statistical analysis. Upon completion of this service, you are provided with all the data and knowledge generated for your API and a robust process to move forward with for development.
Later Stage Development
Crystallization engineering is crucial in achieving consistent particle size distribution, morphology, filtration and drying. Crystallization engineering is usually performed on late-phase APIs where a deep understanding of the effect of process parameters on the quality of the compound is required. At this stage of development, there is already a wealth of knowledge available around the solid state and crystallization behaviour of the API. In many cases, the solvent system is also locked.
With the crystallization engineering workflow, we primarily develop an understanding around the effect of supersaturation release, temperature, pH, mixing regimen, mixing shear and dynamic on nucleation, growth, morphology, polymorphic form (if any), attrition, agglomeration etc. PAT tools such as FBRM will be used to monitor the particle size in real time. The outcome of this work is a scale-independent robust process.