GEA Process Engineering and G-CON Manufacturing have entered into a collaboration with Pfizer to develop PCMM (portable, continuous, miniature, and modular) manufacturing to address the rapidly changing requirements of pharmaceutical development and manufacturing, GEA and G-CON announced in a press release. A preliminary engineering study has already been completed, and the new collaboration will focus on the fabrication and qualification of a prototype unit.
The goal of the collaboration is to create a system that integrates small-footprint, continuous/semi-continuous processing equipment; smart control systems; and self-contained GMP facility modules, known as PODs, to process API powders and inactive ingredients through to bulk tablets or capsules. PODs, which are portable and can be rapidly deployed, are a cost-effective alternative to large, highly capitalized manufacturing facilities with fixed equipment and limited flexibility. This first-of-a-kind system would have the potential to transform the future of pharmaceutical process development and manufacturing while providing the flexibility needed to address the evolving portfolio requirements for in-country and small-lot manufacturing. Additionally, it would have the potential to allow product development, clinical supply manufacture, and commercialization to take place using identical processing equipment, thereby simplifying process transfer, eliminating scale-up, and significantly reducing API consumption during the development process. The platform would ultimately have the potential to support a fast-response, low-inventory supply chain as well.
“This new oral solid-dose manufacturing paradigm will achieve significant cost savings and simplified technology transfer/scale-up from R&D to commercial manufacturing,” said Rod MacKenzie, senior vice-president and head of PharmaTherapeutics R&D at Pfizer, in the press release. “Using the same equipment for development, clinical supplies, and commercial production is expected to maximize efficiencies in manufacturing across the enterprise.”
Upon successful completion of this initiative, GEA and G-CON will work with Pfizer to deploy this complete solution of components and the POD facility globally. To more rapidly advance and develop this vision, Pfizer, GEA, and G-CON will further explore opportunities to partner with additional, interested companies.