Pfizer, GEA, and G-Con Manufacturing initially set out plans to design and build a ‘portable, autonomous manufacturing environment for continuous oral solid dosage production’ using GEA’s ConsiGma 25 system and G-Con's modular system.
On the Road
Now, the platform has been awarded a 2016 Facility of the Year award in the Equipment Innovation category.
Installed at Pfizer's labs in Groton, CT, the current prototype transforms raw materials into uncoated tablets in minutes. The equipment fits in a portable facility called a ‘Pod’ that can be shipped to any location to get medicines to patients when and where they are needed.
Described on the Facility of the Year awards’ website, the innovation is known as PCMM (portable, continuous, miniature and modular) and is designed for the development and manufacturing for solid oral dosage forms. It is a platform that can be used in product development and commercial manufacture. It means that the operator can use the same equipment throughout the entire product lifecycle and to shorten development timelines and technology transfer. This continuous processing equipment was designed and fabricated at GEA’s facility in Wommelgem, Belgium and incorporates both wet granulation and direct compression process capabilities. Both systems convert powder to tablets within minutes, according to the manufacturers.
G-Con designed and fabricated the POD system at its manufacturing facility in College Station, Texas, USA, according to the FOYA awards site. Each system was fully assembled and functionally tested prior to shipment to the final assembly site at Pfizer’s Worldwide Research and Development campus in Groton, Connecticut, USA. Critical to the success of the design effort was the close coordination between the Pfizer, G-Con and GEA Engineering design teams. To meet the schedule, both the process equipment design and POD designs had to be conducted in parallel.
“Receiving this award is a source of tremendous pride to our young firm and shows the dedication of each of the team members and our employees to the success of this bold project. It also validates our cleanroom design principles for rapidly deployable, flexible and repurposable manufacturing infrastructures. We are extremely grateful to our partners, Pfizer and GEA, who collaboratively worked with us to complete this transformative project. We also would like to thank Pfizer for their tremendous vision and drive to initiate and complete this project which we believe will alter the way that drugs are manufactured in the future,” said Maik Jornitz, president of G-Con Manufacturing.
Pfizer will use the PCMM prototype unit to manufacture cGMP clinical supplies of immediate release tablets for various New Chemical Entities (NCEs). The PCMM prototype produces uncoated tablet cores via direct compression and wet granulation processes. In the near future, further POD-based installations containing continuous tablet coating technology are reportedly being planned. A key feature of the POD-based installation is that significant construction/expansion activities can occur without disrupting the ongoing operations within the prototype unit.
The PCMM ConsiGma 25 contains a continuous direct compression and continuous high shear granulation and drying system that converts API and excipients into tablets for development, pilot, clinical and production in a single, compact unit. The system can be configured into a direct compression mode that allows for gravimetric feeding and in-line mixing of these powder streams and direct conversion into tablets. Alternatively, the operation can be reconfigured for wet granulation so that powder streams can be wet granulated, dried, milled and compressed into tablets. There is minimal waste during start-up and shutdown. Batch size is determined simply by how long the machine operates. The system can operate at rates of 5 to 30 kg per hour. Quality is measured throughout the process, with five integrated PAT instruments. The integrated advanced process control system and PAT tools enable monitoring and control during production.
The Pfizer collaboration says it anticipates the opportunity for significant expansion of the platform itself, and PCMM becoming the industry platform for OSD manufacturing. The miniaturisation of the equipment allows the equipment to fit inside a cGMP enclosure, a POD, and that POD can then be placed inside a cost efficient structure. The modular and portability components allow for unit operations to be plugged in when needed. Modularity and portability will also minimise construction issues. Lastly, risks associated with stranded assets/facilities are mitigated due to the modularity and portability of these designs.