PCMM, The Next Generation

Agnes Shanley

Agnes Shanley is senior editor of Pharmaceutical Technology.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

In September 2013, Pfizer, GEA and G-CON Manufacturing launched the PCMM (Portable, Continuous, Miniature and Modular) collaboration with the goal of designing and building a first-of-a-kind modular and transportable oral solid dosage (OSD) drug manufacturing facility. Two years later, G-CON’s pre-fabricated cleanroom PODs and GEA’s OSD continuous manufacturing process train were delivered, installed and assembled in an existing warehouse on Pfizer’s Groton, Connecticut campus. The facility was up and running just weeks after it was delivered, and PCMM won the International Society of Pharmaceutical Engineers'  Facility of the Year award in 2016 for equipment innovation category, with judges citing:

  • Its smaller footprint (i.e., 60-70% smaller than that for a conventional OSD facility)

  • The fact that the same facility could be used for development, clinical trials, and commercial manufacturing

  • Shorter installation and startup times (i.e., approximately one year versus two to three years for standard processes).

Since 2015, Pfizer has used the PCMM facility internally, to develop new chemical entities and products and to manufacture clinical product, says Dennis Powers, director of sales engineering at G-CON. The company has also taken the steps to obtain FDA approval to use the facility to manufacture commercial products in the future, he says. G-CON and GEA have worked with Pfizer to optimize the existing PCMM installation and to add film coating capability to the continuous tableting operation, says Powers. 

GSK joins the effort
In October 2015, GSK joined the PCMM collaboration, opening up the possibilities of additional collaboration and alignment on patient-centered manufacturing goals. Since that time, PCMM collaborators have developed a second-generation PCMM design incorporating new process capability, improved flexibility, and an optimized POD facility layout, says Powers. Taking the lessons learned from Pfizer experience with the start-up and operation of the PCMM installation and incorporating additional continuous manufacturing expertise from GSK, as well as innovations from both GEA and G-CON, the second generation design includes:

  • Tableting and encapsulation dosage form manufacturing capability

  • Direct compression and wet granulation capacity

  • Configurable POD facility design

  • Multiple container format handling ability

  • Additional and optimized support areas.

As Powers explains, the alignment of Pfizer's and GSK’s visions for transforming industry practices and enhancing supply chain capabilities has resulted in a design with superior process technology integrated within an improved modular and portable facility that can be rapidly deployed anywhere in the world.

Members of the PCMM collaboration are promoting  this second-generation design, with the goal of having it become an industry standard for agile, flexible manufacturing of oral solid dosage drugs. "The goal is to manufacture products more quickly for the patients who need them," says Powers.

Both Pfizer and GSK are considering using the second-generation modules internally, says Powers. In May 2017, Pfizer reported, the company started up a PCMM facility at its manufacturing site in Freiburg, Germany.  Although it did not specify whether the facility reflected first- or second-generation PCMM design, the company is clear on its intentions. "With our PCMM system, we can accelerate the development of highly potent drugs and make new drugs available to patients sooner," explained Dr. Kirsten Lund-Jurgensen, executive vice president and president, Pfizer Global Supply. Pfizer invested 50 million Euros on its Freiburg  site, including the PCMM production unit and improvements to continuous manufacturing capacity.