Location: Groton, Connecticut, USA
The Portable Continuous Miniature and Modular Collaboration
Bringing breakthrough medications to patients faster that are affordable and reliably supplied are key objectives of Pfizer. To deliver on these objectives by creating the next generation of Oral Solid Dosage (“OSD”) processing technologies and to address the rapidly changing requirements of pharmaceutical drug manufacturers, Pfizer, GEA, and GCON Manufacturing formed a consortium 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. 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.
Portable, Continuous, Miniature and Modular (PCMM) Development and Manufacturing for Solid Oral Dosage forms— is a platform technology that can be utilized in product development and commercial manufacture; a key innovative advantage is being able to 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 using the standardized platform technology.
G-CON designed and fabricated the POD® system at its manufacturing facility in College Station,Texas, USA. 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. One factor critical to the success of the design effort was the close coordination between 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. Throughout the collaborative design process, innovative approaches were incorporated into the project to increase speed, enhance quality and reduce overall project cost- all ultimately aimed at benefiting patients globally. Significant contributions to the Pharma Industry include:
- Increased project speed significantly reduced project timelines for facility design and construction. The design of the customized air-bearing and POD lifting system allowed the PODs and process equipment to be positioned and installed into a grey space warehouse within one week upon receipt at the landing location.
- Integration of a new vertical, in-line powder mixer for continuously blending pharmaceutical powder streams, integration of five process analytical technology (PAT) sensor systems within the continuous wet granulation and continuous direct compression process equipment and integration of an advanced process control (APC) capability to integrate signals from process and PAT sensors into a real-time monitoring and control system all enhanced quality.
- Lower upfront investment cost compared to traditional facilities and the use of less utilities ( up to 35% energy and resource savings) reduced overall project costs and environmental footprint.
- Efficient experimental study of the process equipment with an estimated ~10 times less material usage and ~10 times faster than conventional batch equipment, multiple formulations and flexible batch sizes, reduction in WIP materials as powder is converted to tablets within minutes, increased OEE and no scale-up from R&D, clinical supply to full scale commercial production were all additional benefits of the project.
Pfizer will use the PCMM prototype unit to manufacture cGMP clinical supplies of immediate release tablets for various New Chemical Entities (NCEs). Today, the PCMM prototype produces uncoated tablet cores via direct compression and wet granulation processes. In the immediate future, further POD-based installations containing continuous tablet coating technology are envisioned. 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.
Facility of the Future
The Pfizer Collaboration anticipates the opportunity for significant expansion of the platform itself, and PCMM becoming the industry platform for OSD manufacturing. The miniaturization 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 minimize construction issues. Lastly, risks associated with stranded assets/facilities are mitigated due to the modularity and portability of these designs. PCMM truly represents a breakthrough platform for facilities of the future.
- Designer/Architect: TLB Architechture, LLC
- Engineer: Hallam ICS
- Main/General Contractor: Harry Grodsky & Co., Inc.
- Major Equipment Supplier(s)/Contractor(s): G-CON Manufacturing, Inc.; GEA Process Engineering N.V.
- Major Equipment Supplier(s)/Contractor(s) of POD: Amec Foster Wheeler; Whitman; Mainstay Engineering Group, Inc.
- Automation and Control Supplier of POD: Rockwell Automation