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Facilities
The UMBI GMP Training and Biomanufacturing Facility is located on the Shady Grove Campus in Rockville, Maryland. The 14,000 sq. ft. facility includes:
- 6,000 sq. ft. BSL-2 production clean room suites for clinical material manufacture
- Analytical laboratories for quality control analyses and environmental monitoring efforts
- Secure documentation management areas for control and storage of GMP documentation
- Research, Process Development and Training Laboratories for educational and developmental activities
- Support spaces for offices, storage and change rooms
The production facility was designed and constructed to GMP standards. It is operated under full GMP compliance for clinical trial materials. The production facility contains two independent production suites, providing the ability to perform two different processes at the same time, maximizing efficiency and capability for the clients needs. These could be two different manufacturing activities and/or training sessions. The GMP facility is equipped with the necessary fermentation, cell culture and purification equipment to produce experimental quantities of biological molecules, cell-based or nanoparticle-based pharmaceuticals for use in preclinical and clinical trials. The maximum single batch scale is 100 liters, using scaling technologies to enable client to continue beyond to much larger volumes. The quality control laboratories has the analytical equipment necessary to monitor facility GMP compliance as well as product quality.
Facility Features
- Multiple suites for multi-product manufacture
- Dedicated room air handling systems
- Continuous monitoring and logging systems for equipment and room parameters
- Unidirectional material and personnel flow through process rooms
- 21 CFR Part11 compliant equipment operation software
- Class 10,000 and 100,000 suites
- Secure / controlled access throughout
- USP Purified water system
- Air balanced room differential pressures and door interlocks to maintain room class integrity
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