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.
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College Station, TX (PRWEB) March 17, 2015
G-CON Manufacturing, producer of prefabricated, flexible cleanroom solutions, 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, TN, will expand the 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 sterilization techniques.
According to Dr. Kennard Brown, the UTHSC Executive Vice Chancellor and Chief Operations Officer, “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 recognized 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 1800 sq. ft. of cleanroom space and incorporate areas for Component Preparation, Compounding/Formulation, Filling and Lyophilization for use in the manufacturing of clinical and small-scale products. An additional POD will provide approximately 760 sq. ft. of cleanroom space for the manufacturing and development of semi-solids products.
“We are very excited and grateful for the opportunity to provide PODs for this critical project at UTHSC,” said Dennis Powers, Director of Sales Engineering at G-CON Manufacturing Inc. “UTHSC’s selection is a reflection of the market’s increased interest in combining aseptic filling processes within our clean room POD technology. Integrated designs like these can be replicated or redeployed anywhere in the world as needed.”
G-CON was selected as part of a project team that includes brg3s Architects, ETFC Architects, and DPS Consulting, Inc. and DPS Engineering. DPS Consulting Inc. (http://www.dpsgroupglobal.com/dps-consulting) is providing pharmaceutical consulting and guidance. DPS Engineering is providing the process architecture and design for the PODs.
G-CON Manufacturing Inc. designs, produces and installs prefabricated, autonomous cleanroom PODs. G-CON’s cleanroom POD portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose the POD once the production process reaches the end of its lifecycle. For more information, please visit the Company's website at http://www.gconbio.com.