The three companies have formed a PCMM (Portable Continuous Miniature & Modular) joint venture to develop a new oral solid dose processing platform, bringing an innovative and cost-effective approach to traditional manufacturing facilities with fixed equipment and limited flexibility.
GEA Process Engineering National Sales Manager H. McCoy Knight told us the “autonomous cleanroom PCMMs are fast and flexibly deployable systems, which are required to act upon drug demand changes and create the opportunity to implement multiple smaller volume sites in various regions.”
Furthermore, the portable, self-contained GMP modules - known as ‘POD’s - “represent a new containment option, allowing multi-product manufacturing options, depending on the product classes.”
If successful, the project hopes to develop a system with a small footprint, continuous/semi-continuous processing equipment, and smart control systems to process active pharmaceutical ingredient (API) and excipients into tablets and capsules.
With the ‘POD’ aspect, manufacturing costs are substantially lower than with traditional facilities due to the elimination of scale up and product transfer stages, Knight said, and so “time to run and therefore time to product launch is greatly reduced.”
“We truly feel this is transformational,” Knight added when asked how the technology could change the industry.
GEA’s views were supported by Pfizer and G-CON Manufacturing who both said:
“With today’s development manufacturing paradigm in a cost-constrained environment, it is becoming increasingly important for companies to have the ability to rapidly deploy (and in some cases redeploy) assets, mandating the use of agile facilities that allow for portability, miniaturization and modularity.”
However, G-CON’s COO Jornitz told us the project itself is not a preemptive to the facility design needs of the industry ,but rather it verifies “that such transformation is necessary and possible.”
Pfizer’s Pfuture Pfacilities
GEA and G-CON have said they will work with Pfizer to deploy the technology components and the POD facility globally, though for now all three firms remained muted on any future strategy once a prototype has been made.
Pfizer spokesperson Andrew Widger told in-Pharmatechnologist.com “as this is at prototype phase, it’s difficult to put a clear timeframe on development.”
When asked whether there were plans to license the technology to other OSD manufacturers, he suggested that at least to begin with the collaboration would focus on its own facilities.