Modernizing manufacturing of parenteral products - From batch to continuous lyophilization

Even though continuous manufacturing has long been applied in a wide variety of industrial fields, the pharmaceutical industry strongly relies on batch production, which is incompatible with the fast-changing market demand. Furthermore, the transition from batch to continuous manufacturing strategies would be beneficial to the reduction of the production time and footprint, higher yield, improved process flexibility, and easier Quality Assurance. So far, the strict rules imposed by the regulatory authorities have pushed most pharmaceutical companies to use well-established batch technologies. Nonetheless, the increasing demand for drug products and the inherent inefficiency of batch production have led to the development of new ideas and, hence, patent filing which may accelerate the transition to innovative manufacturing technologies, including continuous ones. The present contribution aims to provide a comprehensive description of the most promising continuous concepts for freeze-drying which can further promote the development of an end-to-end continuous manufacturing plant for pharmaceutical products.