Head of R&D Pharma MyBiotech GmbH Ueberherrn, Germany
Presentation Description: Continuous production becomes increasingly popular for large-scale production of nanoparticles, since flexibility during development and early processes establishment that can be directly transferred to industrial environments offer better process understanding and facilitate commercial manufacturing process. Development of flexible and continuous particle manufacturing (CPM) technologies, however, remains to be an unmet need in nanomedicine. Here presented novel CPM technology offers versatile manufacturing method enabling the choice of most convenient strategy, top down or bottom up, using a single set-up, where integrated Process Analytical Tools (PAT) offers online production monitoring, thus, robust processes to yield batch-to-batch reproduciblity. In bottom up method different active pharmaceutical ingredients (APIs) are dissolved in appropriate organic solvent(s) in the presence of excipient(s) and sprayed into non-solvent stream using the CPM technology. In top down method APIs are dispersed in water phase with(out) excipients and is sprayed against a plate under high pressure to reduce the particle size.
Upon completion, participant will be able to choose their particle manufacturing method based on a rational design to maximise the particle quality, safety and efficacy-
Upon completion, participant will be able to design particle development strategies for maximum yield by comparing different manfuacturing methods based on either top-down or bottom-up approach
Upon completion, participant will be able to integrate qualiy-by-design concepts to their innovative particles and their manufacturing methods