What can be the future paradigm for continuous manufacturing? Would it be possible to fully integrate manufacturing beginning with the raw materials for an active pharmaceutical ingredient (API) to a finished drug product? How about now? To what extent is continuous manufacturing being applied in the pharmaceutical industry? At a series of discussions at Interphex this week, industry members shared their perspectives on the current and future direction of continuous manufacturing.
The goal of end-to-end fully integrated drug manufacturing in a continuous manufacturing environment was discussed by James Evans, associate director of the Novartis-MIT Center for Continuous Manufacturing. The Novartis-MIT Center for Continuous Manufacturing is a 10-year, $65-million research collaboration, formed in 2007, which is developing new technololgies and related processes in continuous manufacturing. The focus of the research is to integrate small-molecule chemical synthesis with solid-dosage product manufacturing in a continuous manufacturing environment. Although continuous manufacturing is now applied singularly in API manufacture, for example, through microreactors, or in solid-dosage manufacturing, for example, through continuous manufacturing of specific unit operations, the idea of integrating drug substance and finished product manufacturing in an end-to-end fully integrated platform may be a high-reaching fruit in a continuous manufacturing paradigm, but one in which the center is seeking to develop.
The pharmaceutical industry’s interest in improving manufacturing operations as a means to realize process improvements, manufacturing efficiencies, and cost savings through continuous manufacturing also was expressed by other panelists at the Interphex Main Stage presentations. For example, Alex Cheung, director and team leader of the Technology, Science, and Operations Group, Pfizer Global Supply Division, Pfizer, offered several examples of commercial projects in which the company is applying continuous manufacturing in API synthesis and other projects in which continuous manufacturing is being applied in solid-dosage operations.
Fernando Muzzio, professor of chemical engineering at Rutgers University, and president of Mixing Consultants, outlined the technical feasibility of continuous processing in solid-dosage manufacturing. And Moheb Nasr, director of the Office of New Drug Quality Assessment, CDER, FDA, also contributed to the dialogue by outlining the agency’s support for continuous manufacturing and its interest in working with companies as they seek to develop and implement such approaches.
The take-away from these discussions is that continuous manufacturing is certainly part of the current and future direction of pharmaceutical manufacturing. Greater process understanding and process control and the resulting benefit of improved product quality, along with better production economics, make continuous manufacturing a strong proposition for the industry. The extent and pace of adoption, however, has to be balanced with the business case in the near term with the financial realities of adapting manufacturing, particularly in a current environment of excess capacity, as well as addressing certain technical challenges. But bottom line: continuous manufacturing is here to stay.