Biological Resources Branch (BRB)
Biopharmaceutical Development Program (BDP)
The Biopharmaceutical Development Program (BDP) operates within the Frederick National Laboratory for Cancer Research (FNLCR), which is located at the Advanced Technologies and Research Facility (ATRF) in Frederick, MD. The BDP receives operations and technical support under a contract with Leidos Biomedical Research, Inc. The BRB staff provides oversight and guidance to BDP for the production of biopharmaceuticals, under current Good Manufacturing Practices (cGMP), that are proposed for preclinical and early (e.g. Phase I and II) human clinical trials, or advanced preclinical animal testing. Biopharmaceuticals include, but are not limited to, monoclonal antibodies, recombinant proteins and virus-like particles, viral and DNA vaccines, peptides, gene therapy products, and cell-based products such as engineered T cells. The program is uniquely situated to address first-in-class and novel technologies, orphan markets, and complex regulatory challenges associated with these unique agents. The BDP supports translational research from NIH extramural and intramural scientists using contract mechanisms.
BDP capabilities include:
- cGMP manufacturing, filing, testing, and release
- process development and feasibility studies
- process analytics/QC testing
- quality assurance oversight
- regulatory affairs support
- technology transfer support
- training on Good Manufacturing Practice regulations (21 CFR 210, 211)
Preclinical Biologics Repository
The preclinical repository stores cytokines, monoclonal antibodies, and other biologic reagents under carefully controlled conditions. The repository provides, at no charge, a limited supply of high-quality reagents to qualified researchers at academic and non-profit institutions. Find more information on available reagents and ordering instructions.
Grants Portfolio
The BRB manages a grant portfolio consisting of approximately 130 funded grants, totaling ~$30M per year. The subject matter of these grants is largely focused on the development biopharmaceuticals appropriate for anti-cancer testing in animal models and other pre-clinical studies to support clinical translation. Examples include monoclonal antibodies (conjugated and unconjugated), cytokines, gene therapy using a variety of vectors, delivery of biological agents, antisense and siRNA therapy, engineered cell therapies, specific animal models, and combination therapies. Although most of the grants are preclinical, some early Phase I pilot trials are also included in the BRB grant portfolio.