Session: Pharmaceutical Process Development and Pilot Plants

Papers are invited on experimental and theoretical studies on the development and scale-up of pharmaceutical processes. Cases involving models, statistical designs, process control, and analytical data acquisition are encouraged. Efforts can include, but are not limited to applications in small molecule and biologics API processing such as: crystallization, reactions, separations/purification, downstream processing, drying and size reduction. Studies in solid and liquid drug product manufacturing are also relevant such as direct compression, granulation, tablet/capsule production, liquid dosage formulations, softgels, parenterals, lyophilizaiton. Scale-up efforts are sought after in both aseptic and conventional GMP pilot plant settings.