GEA, G-CON, and Pfizer Collaborate on Continuous Manufacturing Process

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.”