Process development activities are a series of steps to develop and control the process parameters whilst scaling up the activities. Purification optimization aims to enhance the purity and quality of the API. Process parameters such as temperature, pressure, and reaction times are developed to maximize yield and quality. Analytical support ensures reliability and consistency during the efforts to scale-up the process volumes. These stages are essential for validating and preparing the process technology before proceeding to greater batch sizes.
Commonly, preliminary process development ends with a representative technical batch expected to match required technical specs.