NCI BRB Biopharmaceutical Development Program
The BRB oversees the operation of a pilot multi-product CGMP facility located on the NCI-Frederick campus. The BDP facility is a GOCO, Government-Owned Contractor-Operated set of labs, production suites, and offices currently contracted to SAIC-Frederick, Inc. The BDP is responsible for most of the translational research projects; however, some or all aspects of unusual projects need to be outsourced to specialized contract manufacturers.
The following capabilities and resources of the BDP are explained in greater detail on the BDP website (http://wwwbdp.ncifcrf.gov):
- Natural products fermentation: 30, 300, 3000 gallon
- Hollow fiber, packed bed, and WAVE technology for mammalian cell production
- Bacterial fermentation: 20, 80, 100, 1000 liter
- Process development and optimization: Fermentation/production, recovery, refolding, purification, analytical, stability
- ISO 2 Standard cleanroom for GMP vialing operations
- ISO 4 BSL-3 suite for virus manufacturing/purification
- Facilities and equipment validation programs
- Quality Control: In-process and product release testing, environmental monitoring
- Quality Assurance: Documentation management, CGMP training, vendor auditing
- Regulatory Affairs: CMC documentation, FDA interactions
- Project Management: Cost estimates, outsourcing, project/staff scheduling, billing
BDP Projects Page
BRB RAID Projects Page
Translational Research
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