The Pfizer Continuous Manufacturing Module (PCMM) is capable of manufacturing tablets via either direct compression (DC) or wet granulation (WG). The initial commercialization of DaurismoTM (Glasdegib) and CibinqoTM (Abrocitinib) was achieved in 2018 and 2021 respectively using a PCMM- DC continuous direct compression approach. In this case study we will discuss the development of the PCMM-WG technology for Pfizer’s third NCE small molecule compound. This presentation will primarily be focused on the development of the multi-component control strategy which integrates multiple elements, including PAT and end-to-end flowsheet modeling to capture the process dynamics, and ensure a robust control of the process.
