Pfizer has announced a multi-year collaboration with GSK on the development of a next-generation equipment design, building upon Pfizer’s existing portable, continuous, miniature and modular (PCMM) prototype for oral solid dose (OSD) pharmaceutical development and manufacturing.
Pfizer’s current PCMM prototype is an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module that is compliant with industry-standard good manufacturing practice (GMP) guidelines.
Together with GSK, which has notable technical and regulatory experience in continuous processing, Pfizer will conduct coordinated experiments to create the next-generation design of Pfizer’s current PCMM prototype. This collaboration expands upon Pfizer’s existing collaboration with GEA and G-CON Manufacturing, which resulted in the design of the current prototype unit presently implemented at Pfizer’s labs in Groton, Conn.
“Pfizer’s success in building a first-of-a-kind, transportable, modular prototype for oral solid dose pharmaceutical development and manufacturing holds promise to help transform industry practices, and we invite other organizations to join us in this effort,” said Rod MacKenzie, senior vice president, PharmaTherapeutics Research & Development at Pfizer. “We believe coupling Pfizer’s industry-leading development and manufacturing capabilities with GSK’s experience and expertise in continuous processing has the potential to lead to a superior technology, thereby allowing us to more quickly and efficiently bring therapies to patients.”
“GSK is pursuing a strategy to enhance our manufacturing supply chains and drive access to medicines for patients. Continuous manufacturing is a key part of that strategy,” said Mark Buswell, Vice President and Head of Advanced Manufacturing Technologies at GSK. “This strategic collaboration allows Pfizer and GSK to align on a vision for PCMM-OSD equipment designs and enables us to deploy flexible, agile and reliable manufacturing solutions to benefit patients.”
About Pfizer’s PCMM Technology
Pfizer’s PCMM technology is a first-of-a-kind manufacturing system that accelerates the speed of tablet production. The pharmaceutical industry has been trending toward lower-volume products, driven by an increased focus on precision medicine approaches to develop and commercialize new therapies. This creates a need for smaller, more flexible continuous processing technologies.
By miniaturizing the equipment, the continuous process can be enclosed in a portable, autonomous space called a POD, which can be transported to any location in the world and quickly assembled.
The PCMM technology has the potential to transform the current biopharmaceutical industry standard of using batch processing to manufacture tablets and capsules from powders—an oftentimes complex process that requires large, dedicated manufacturing facilities. The PCMM continuous process takes only minutes from the addition of raw materials to the completion of finished tablets or capsules.
Highlights of PCMM’s potential for smaller, more flexible, continuous processing technologies include:
- A PCMM facility has a 60 to 70% smaller footprint than a conventional production facility.
- PCMM enables use of the same equipment for development, clinical trials and commercial manufacturing.
A PCMM facility takes about one year to set up and start running, compared to two to three years for standard processes.