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Drug Development

A grim statistic is driving Steven Rosenberg’s mission to find new cancer treatments—and his partnership with Frederick National Laboratory (FNL) to do so. “Every year in the United States, about 600,000 people die of cancer, 90% of whom die of the solid epithelial cancers,” said Rosenberg, the M.D., Ph.D., chief of the National Cancer…
The Frederick National Laboratory for Cancer Research and biotech company Progenra, Inc., recently signed a contractor Cooperative Research and Development Agreement (cCRADA) to develop a novel therapy that could be capable of degrading KRAS. The human KRAS gene is one of the most elusive and potentially promising cancer therapy targets.…
Since its inception, the Biopharmaceutical Development Program has manufactured more than 250 lots of 100 different biopharmaceuticals to support human clinical studies, including: Proteins and peptides Recombinant proteins Monoclonal antibodies (murine/humanized/chimeric) Immunotoxins Cytokines Immunocytokines Nucleic acids…
The Biopharmaceutical Development Program offers resources for and expertise in the development of investigational biological products that move promising treatments for cancer, rare diseases, AIDS, and infectious diseases into clinical trials.  Image The program provides leading-edge development and analytical…
Overview The use of nanotechnology has become common in the pharmaceutical industry due to the benefits that nanoparticles offer to drug delivery, vaccines, immunotherapies, and medical devices. The Nanotechnology Characterization Laboratory has characterized over 400 nanotechnology-based concepts, 17 of which advanced to clinical trials. Among…
Overview The National Cancer Institute RAS Initiative endeavors to better understand the RAS oncogene and discover its vulnerabilities to treat RAS-related cancers. About one-third of all human cancers are driven by mutations of the RAS family of genes. Though scientists have known about RAS for more than 30 years, a treatment to block…
The Vaccine Clinical Materials Program conducts the tech transfer, manufacture, and supply of early phase clinical materials for use in investigational studies targeting infectious diseases of global significance. We are a team of highly trained scientists, technicians and professionals that operate a pilot plant engaged in the production,…
An anti-HIV antibody called VRC01 does not protect people from acquiring HIV, according to findings from the Antibody-Mediated Prevention (AMP) Trials. The results were recently reported in the New England Journal of Medicine. While they indicate that this antibody alone is not a strong HIV-prevention measure, the data suggest that antibodies…
The Food and Drug Administration has approved a monoclonal antibody developed at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the treatment of Ebola virus in adults and children. The approval was granted in late December. The antibody, called…
The Frederick National Laboratory (FNL) has begun building out new production space that will triple its capacity to manufacture cell and gene therapies to support cancer clinical trials. BDP manufacturing staff use a Miltenyi Prodigy for CAR T-cell production. Incubators seen in the background are available for non-Prodigy based cell…