GSK and Pfizer team up on continuous manufacturing project
Pfizer's portable, continuous, miniature and modular (PCMM) system - currently at the prototype stage - is designed to break away from the conventional batch manufacturing model used in pharma and towards continuous manufacturing.
In continuous manufacturing, drugs are continuously produced in highly-automated, closed units that allow changes to the production parameters on the fly.
The approach only allows production to be tweaked if quality issues emerge - avoiding the need to lose an entire batch - and also ties in with the shift towards flexible manufacturing of smaller volumes for specialised applications, such as personalised medicines.
Pfizer developed the first generation of its PCMM system along with GEA and G-CON, and describes it as "an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module."
In PCMM, equipment for continuous processing of OSDs -covering blending, granulation, drying, milling and compression - is contained within a self-contained, autonomous cleanroom environment with integrated materials handling, cleaning and air-locked access.
Drawing on GSK's experience
The original PCMM is currently being out through its paces at Pfizer's facility in Groton, Connecticut, and the company said it will draw on GSK's "notable technical and regulatory experience in continuous processing" as it develops a next-generation version of the platform.
As it stand, the current PCMM only requires around two-thirds the space of a conventional facility, and can be used to manufacture a product right from the early stages of development through to commercial production.
Similarly, it takes around a year to set up, compared to two or three years for conventional production lines. Taking all those factors together that means costs are also substantially lower.
GSK in Singapore
GSK was an early adopter of continuous processing and is one of the only drugmakers to operate a plant dedicated to the approach, in Singapore, which was set up in 2013 with an investment of $50m.
Earlier this year, GSK earmarked another $60m for the project, intended to build a downstream processing facility to sit alongside the existing plant, which make the antibiotic amoxicillin.
Another plant in Singapore - making respiratory active pharmaceutical ingredients (APIs) - is due to open a continuous processing line early next year.
"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," said Rod MacKenzie, senior vice president of PharmaTherapeutics R&D at Pfizer.
"We invite other organizations to join us in this effort."
