G-CON Manufacturing has been selected to build a multi-POD ISO Class 7 formulation and filling suite for the University of Tennessee Health Science Center (UTHSC).
The new facility in Memphis, Tennessee, will expand capabilities of the UTHSC Plough Center for sterile drug delivery, which is currently used for process development, analytical and stability studies, as well as hands-on training in aseptic processing and sterilisation techniques.
UTHSC executive vice-chancellor Dr Kennard Brown said: "UTHSC’s primary goal was to build a facility that enabled them to offer assurances to the pharmaceutical industry and the general public that any products produced in the facility were done so at the highest cGMP quality standards.
"The university’s focus with the new facility will be the development and manufacture of unique drug products with innovative drug delivery systems.
"The Plough Center hopes to become recognised for its ability to formulate and manufacture difficult to produce new drug products for clinical trials and for paving the way for manufacturing medicines of the future such as antibody-drug conjugates, nanoparticles and bio-similars."
The PODs will provide approximately 1,800ft虏 of cleanroom space and incorporate areas for component preparation, compounding, formulation, filling and lyophilisation for use in the manufacturing of clinical and small-scale products.
An additional POD will provide approximately 760ft虏 of cleanroom space for the manufacturing and development of semi-solids products.
G-CON Manufacturing Sales Engineering director Dennis Powers said: "UTHSC’s selection is a reflection of the market’s increased interest in combining aseptic filling processes within our cleanroom POD technology.
"Integrated designs like these can be replicated or re-deployed anywhere in the world as needed."
G-CON was selected as part of a project team that includes brg3s Architects, ETFC Architects, DPS Consulting and DPS Engineering.
DPS Consulting is providing pharmaceutical consulting and guidance. DPS Engineering is providing process architecture and design for the PODs.