Scaling up and transferring an API or drug product process from pilot to manufacturing scale is no simple task. Changes to vessel temperature, distillation volume, and hold times are just a few parameters that can significantly impact either API phase or attribues. Crystal Pharmatech has significant experience in manufacturing scale unit operations and can aid in identifying critical process parameters that are impacting the physical attribute quality of your process. We also have extended experience in identifying root cause in OOS investigations.
