The Importance Of Continuous Manufacturing Research And Development For Small Molecule Pharmaceutical Products

Dr. Malcolm Berry is a recognized leader in the field of continuous processing for small molecules, whose work includes the development of the world’s first FDA- and EMA-approved multistage continuous production platform, as well as the lab-based technology and a workflow for developing continuous active pharmaceutical ingredient (API) processes. Dr. Berry has decades of experience working in the pharmaceutical industry as an organic chemist, including 26 years in process research and development in GlaxoSmithKline. He also has extensive experience working in research and development (R&D) pilot plants and leading the technical transfer of both new batch and continuous processes from R&D to manufacturing. In 2019, Dr. Berry left Glaxosmithkline (GSK) and started a successful continuous API consulting practice that grew throughout the global pandemic. In 2022, Dr. Berry began a partnership with Phlow Corp, a U.S.-based essential medicines public benefit company, to enable peer-to-peer collaboration and the development of customized solutions for pharmaceutical and biotechnology companies as part of Phlow’s Continuous Care.

This Q&A explores the evolution of numerous chemistries and processes for new drug molecules, disruptive technology, process design and workflow, the importance of the application and integration of Process Analytical Technologies (PAT), and regulatory considerations when integrating continuous flow technology.