NCI BRB Biopharmaceutical Development Program

The NCI BRB Program Staff provide oversight of the Biopharmaceutical Development Program (BDP) at the NCI, the Frederick National Laboratory for Cancer Research (NCI FNLCR). The BDP produces a variety of biopharmaceuticals under current Good Manufacturing Practices (cGMP) for Phase I/II human clinical trials or advanced preclinical animal testing. The BDP is operated under contract by Leidos Biomedical Research, Inc., which provides operations and technical support to the FNLCR.

The BDP aims to advance the development of novel therapeutics for treatment of cancer and other diseases by providing manufacturing, process development, process analytics, and quality assurance capabilities and expertise. The BDP supports extramural and intramural NIH innovators to advance novel therapeutics. The program is uniquely situated to address:

  • first-in-class and novel technologies
  • orphan markets
  • complex regulatory challenges selected for scientific interest.

Capabilities

The following capabilities of the BDP are explained in greater detail on the BDP website:

  • cGMP manufacturing, filing, testing, and release
  • Process development and feasibility studies
  • Process Analytics/QC testing
  • Quality Assurance oversight
  • Regulatory Affairs support
  • Training on Good Manufacturing Practice regulations (21 CFR 210, 211)
  • BDP provides development and manufacturing capabilities for the following types of products: monoclonal antibodies, recombinant proteins, viral and DNA vaccines, peptides, gene therapy products, and other protein, nucleic acid, and whole cell based products.