Salvatore Mascia, PhD.
Although there has been a number of successful continuous manufacturing implementations within the pharmaceutical industry, there are still challenges toward a seamless end-to-end integration of a manufacturing process. In particular, novel solutions for continuous operation of filtration and drying, occurring post-crystallization of API, can be very important for end-to-end integration. Similarly, there are opportunities to rethink about the current drug product process by making use of polymers and produce tablets from extruded material, thin-films and/or electro-spinning processes. These approaches have potential to eliminate the need for the current multi-step, drug product process where often a “corrective” wet granulation is required, followed by drying and compression into tablets.
This talk aims to introduce technological innovation in continuous filtration and drying of final API, as well as novel continuous drug product processes to limit solid handling procedures, reduce number of steps, and streamline the process by enabling the integration of API and drug product into one seamless process.