Düsseldorf (Germany), March 10, 2016 – Pfizer combines GEA’s continuous processing technology with G-CON portable cleanroom PODs for the manufacture of drug tablets anytime, anywhere.
A flexible and configurable continuous pharmaceutical tablet processing technology developed by GEA has won an international award as part of a groundbreaking mobile manufacturing platform developed in collaboration with Pfizer and G-CON. The prototype Portable, Continuous, Miniature and Modular (PCMM) manufacturing platform, now operational at Pfizer’s facility in Groton, Connecticut, scooped Pfizer the International Society for Pharmaceutical Engineering (ISPE)’s 2016 Facility of the Year Award (FOYA) for Equipment Innovation.
Conceived, designed and built through a future-facing initiative between the three partners, the PCMM technology has at its center GEA’s state-of-the-art miniaturized and mobile ConsiGma™ continuous oral solid dosage (OSD) pharmaceutical processing technology. Configurable for either, direct blending and compression of powder streams into tablets, or for wet granulation, drying, milling and tableting, the ConsiGma™ system features a new vertical in-line powder blender. Five process analytical technologies (PATs) have been integrated into the system to continuously monitor and control all process and quality parameters, and ensure minimal losses in the event that production needs to be stopped or process parameters need to be changed. G-CON has designed and constructed a modular, prefabricated, and highly maneuverable POD® system that can rapidly be set up around the equipment to provide a GMP-compliant cleanroom environment.
The PCMM technology represents a completely self-contained and mobile continuous manufacturing system that can be transported to geographical areas of need, and installed within days to produce as much or as little drug as required, whether for product development, clinical trials manufacture or commercial production. When production is no longer required the unit can just as easily be disassembled and transported to another site. This agile concept for continuous manufacturing could feasibly make huge, purpose-built production plants a thing of the past, significantly reducing capital expenditure and operational redundancy. And with industry driving to reduce costs, increase quality and focus on patient-centric manufacturing, GEA believes that PCMM manufacturing will become the industry standard platform for processing OSD therapeutics.
“We are delighted that the PCMM solution received this prestigious award from the global pharmaceutical engineering society represented by the ISPE,” comments Frans K. A. Maas, Vice President, Application Center (APC) Pharma Solids at GEA. “The consortium of Pfizer, G-CON and GEA have been working successfully on this groundbreaking manufacturing innovation, now in operation in Groton. We’re convinced that this platform, based on GEA’s ConsiGma™ continuous manufacturing technology, provides significant benefits to both the generic and the ethical industry segments when compared with more traditional batch technologies, and is in line with FDA’s guidelines for future solids manufacturing innovations.”
"We are proud to have been part of this award-winning collaboration in manufacturing technology, engineering and design, which we believe will change the face of OSD drug manufacture globally,“ comments H. McCoy Knight, Vice President APC Pharma North America. "As a leading innovator of manufacturing concepts, analytical technologies and processing equipment design, GEA will continue to play a major role in the drive to develop OSD manufacturing technologies and solutions for efficient, cost-effective and patient-centric manufacturing."