(159e) Building a Continuous Crystallization Capability for Pharmaceutical R&D

Continuous processing of pharmaceuticals is a growing area of interest, with many companies engaged in the effort for both “flow chemistry” and continuous drug product manufacture. A critical missing link between these more popular areas of study is continuous crystallization, isolation, and drying (CCID). Recognizing this essential need, Pfizer have begun developing a CCID capability to provide a critical bridge between synthetic steps as well as enable a “raws in, products out approach,” creating a fully connected continuous processing chain from starting materials to drug products. The approach is based on several distinct pillars: Workflows, Equipment (Lab and Plant scale), PAT, Process Modeling and Control, and Nucleator Design. Each will be discussed in turn and within the context of Pfizer projects and case studies. Challenges in these pillars will be discussed, as well as several opportunities to enhance the capability of the kit. Finally, a modular CC skid for manufacturing in a kg/day scale plant will be presented, showing elements from all the pillars of the platform.