This new OSD manufacturing paradigm will achieve significant cost savings and simplified technology transfer/scale-up from R&D to commercial manufacturing.
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(PRWEB) September 24, 2013
GEA Process Engineering and G-CON Manufacturing announced today that they have entered into a PCMM (Portable Continuous Miniature & Modular) manufacturing collaboration with Pfizer Inc. with the aim of developing the next generation of oral solid dose (OSD) processing technologies to address the rapidly changing requirements of pharmaceutical development and manufacturing. This collaboration brings together three companies with leading 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 already been completed, and the new collaboration will focus on the fabrication and qualification of a prototype unit.
“We are very enthusiastic to be working with Pfizer, a leading multinational pharmaceutical corporation, and G-CON to develop a turnkey solution for a continuous and portable manufacturing system,” says Jan Vugts, Managing Director, GEA Pharma Systems. “This project is another milestone in the advancement of the GEA Process Engineering Continuous Manufacturing activities in pharmaceuticals. 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. 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. "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," states Maik Jornitz, Chief Operating Officer, G-CON Manufacturing LLC. "We are privileged to work with Pfizer and GEA and look forward to achieving the goals of the consortium."
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.
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.”
To more rapidly advance and develop this vision, Pfizer, GEA and G-CON will further explore opportunities to partner with additional, interested companies.