To develop oral solid dose processing technologies to address changing industry requirements
GEA Process Engineering and Texas-based G-CON Manufacturing have entered into a PCMM (Portable Continuous Miniature & Modular) manufacturing collaboration with Pfizer, with the aim of developing oral solid dose (OSD) processing technologies to address the rapidly changing requirements of pharmaceutical development and manufacturing.
This collaboration brings together three companies with capabilities in product development and manufacturing, OSD processing equipment, and portable, self-contained Good Manufacturing Practice (GMP) facility modules, known as PODs.
A preliminary engineering study has been completed, and the new collaboration will focus on the fabrication and qualification of a prototype unit.
'This project is another milestone in the advancement of the GEA Process Engineering Continuous Manufacturing activities in pharmaceuticals,' said Jan Vugts, Managing Director, GEA Pharma Systems. 'It builds on the experience of Pfizer and GEA in Real Time Release and has the capability to set the next standard for OSD manufacturing.'
The goal of the collaboration is to create a system that integrates small footprint, continuous/semi-continuous processing equipment, smart control systems, and PODs to process active pharmaceutical ingredient (API) powders and inactive ingredients through to bulk tablets or capsules. The firms say PODs, which are portable and can be rapidly deployed, are a cost-effective alternative to large, highly capitalised manufacturing facilities with fixed equipment and limited flexibility.
'G-CON's team is very excited to be part of this project and to again demonstrate the flexibility and quality of our autonomous cleanroom POD systems, this time in a solid dosage form application,' said Maik Jornitz, Chief Operating Officer, G-CON Manufacturing.
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, said G-CON. Additionally, it would have the potential to allow product development, clinical supply manufacture, and commercialisation 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 also ultimately have the potential to support a fast-response, low-inventory supply chain.
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.
'This new OSD 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. 'Using the same equipment for development, clinical supplies, and commercial production is expected to maximize efficiencies in manufacturing across the enterprise.'