PharmaPy 2.0: Dynamic process modeling and analysis of end-to-end continuous pharmaceutical manufacturing

As pharmaceutical manufacturing transitions from traditional batch processes to continuous manufacturing (CM), there is a need for CM design and development tools that integrate drug substance and drug product unit operations to enable a comprehensive assessment of product quality. PharmaPy, a Python-based framework was recently proposed to advance CM. The original model library, however, only covered drug substance processing. In this work, new capabilities, including drug product unit operations such as feeder, blender, roller compactor, milling, and tablet press, have been added to the PharmaPy framework, enabling end-to-end dynamic study of direct compaction and dry granulation processes. The platform supports the integration of drug substance and product parameters to evaluate their combined impact on final product quality attributes. Sensitivity and feasibility analysis are performed on the integrated simulator to identify critical input variables and their corresponding design spaces for achieving desired product quality. The dynamic response of process models is studied through step changes in input variables. The enhanced PharmaPy package can now support decision-making from early research and development stages through manufacturing.