Plough Center for Sterile Drug Delivery Systems Facility, United States of America
A new drug manufacturing facility for the University of Tennessee Health Science Centre in Memphis, Tennessee is expected to begin construction in September 2015.
The new facility, which will be known as Plough Center for Sterile Drug Delivery Systems, will house pre-manufactured cleanroom pods for the manufacture and filling of clinical trial drugs. It will provide aseptic formulation and clinical trial drug compounding services on a contractual basis for the private sector.
It will be built in compliance with current good manufacturing practices (cGMP) to produce small-batch drugs in injectable and semi-solid dosage forms for preclinical Phase 1 and Phase 2 clinical trials.
The facility will be constructed by replacing the 32,000ft² warehouse located at 208 S Dudley Street, which was purchased from Dudley Properties for $750,000 in June 2011. The University of Tennessee filed a $3.7m permit application for the project with the Shelby County Department of Construction Code Enforcement in July 2015.
Details of the sterile drug delivery systems facility
The sterile drug delivery systems facility will have total floor space of 32,000ft², which will include 17,200ft² of pre-fabricated sterile pods. It will also include three 800ft² pre-fabricated pods, which will serve as sterile environments for aseptic pharmaceutical manufacturing.
Pre-fabricated pods will include temperature-controlled and smaller spaces, which will give control over sterilisation while preparing, compounding and filling pharmaceuticals at a small scale. There will be 10,000ft² of space dedicated to support labs, offices and training facilities.
The facility will manufacture orphan drugs developed to treat specific and rare diseases, and innovative drug delivery systems. It will provide training to students and professionals from the pharmaceutical industry, and government regulatory agencies in production.
The two blocks in operation are dedicated to the manufacturing of cephalosporins and general injectables.
Construction of the facility is expected to begin in September 2015 and is aimed for completion within 24 months. It will include renovation of the old warehouse, refurbishing the interior of the building, and updating the exterior.
G-CON Manufacturing Sales Engineering was contracted to build a multi-pod ISO Class 7 formulation and filling suite for the new facility in March 2015. The project team includes brg3s Architects, ETFC Architects, DPS Consulting, and DPS Engineering.
DPS Consulting will provide pharmaceutical consulting and guidance, while DPS Engineering will provide process architecture and design for the pods.
The facility will be constructed with an estimated investment of $16m. Plough Foundation contributed $4.5m towards construction.