Maximizing Available Space While Meeting the Stringent Requirements of cGMP Ceanroom Standards with our Cell Therapy Facility
The Department of Transfusion Medicine (DTM) at NIH required an increase in production capacity for clinical trials, specifically to manufacture products used to test and treat NIH Clinical Center patients with cancer, haematological malignancies, marrow failure, congenital immune disorders, and autoimmune diseases. Germfree was tasked with designing and building a modular cell therapy facility that could meet the stringent requirements of cGMP cleanroom standards while maximizing the available space.
Size: 6,400 sq. ft.
Layout configurations: 6-module cell therapy facility
Facilities/Equipment: MP cleanroom, support and mechanical space
Features: Full central utility plant on top of the modules to reduce the facility shell building size
One of the key features of this cell therapy facility was a full central utility plant on top of the modules. This allowed the NIH to reduce the size of the overall facility shell building, resulting in cost and schedule advantages.
To meet the needs of our client, we designed and built a 6-module facility with 6,400 sq. ft. of cGMP cleanroom, support, and mechanical space.
How we helped
The modular facility was installed on top of the East Terrace of Building 10 which allowed the NIH to take advantage of space that had poor utilization. The cell therapy facility complies with current Good Manufacturing Practices (cGMP) as they apply to pertain to producing cell therapy products for clinical investigations.
Cell therapy facility details
The DTM cGMP Cell therapy facility is made up of six prefabricated modules, which include four ISO-7 cell processing suites, ISO-7 and ISO-8 cleanroom lab spaces, tissue culture suites, and cold room storage. A second story interstitial level mezzanine provides mechanical equipment to support the facility and Building 10 supplies electrical infrastructure to the facility.
The processing suites are unidirectional flow for personnel, materials, product and waste. Key materials of construction for the cleanroom interior included Arcoplast wall panels for walls and ceilings with coved corners and joints and stainless steel doors. The modular facility including all structures and utilities (MEP) were provided turnkey. The facility was factory built and tested at Germfree in Ormond Beach, FL.
Germfree is proud to have contributed to a critical project that will impact the lives of patients with serious medical conditions. Our team worked closely with our client to develop a customized solution that met their specific needs while adhering to the highest standards of quality and safety. We believe that this project will help to advance the field of cellular therapy and improve patient outcomes, and we are honored to have played a role in making that possible.
This facility was built using Germfree’s proven modular cleanroom platform, click here to learn more about our modular cleanrooms.