The Biopharmaceutical Development Program offers resources for and expertise in the development of investigational biological products that move promising treatments for cancer, rare diseases, HIV/AIDS, and other infectious diseases into clinical trials. We focus on products that are in early development, beginning with the demonstration of production feasibility. Following process development and biomolecular characterization, we move these products through manufacturing for phase 1 and 2 clinical trials.  

We’re experienced in the transfer of manufacturing and testing methods developed to support industry and government programs that own the licensed product rights for commercialization. We ensure compliance with the U.S. Food and Drug Administration current Good Manufacturing Practice (cGMP).   

We work under collaborative agreements with government agencies, academia, and industry, including national and international companies. Collaboration opportunities are reviewed and approved by the National Cancer Institute Division of Cancer Treatment and Diagnosis. For project inquiries and access to the program, contact the NCI Biological Resources Branch

Expertise, services not readily available in commercial market 

We have the manufacturing capacity to support multicenter clinical trials funded by the National Cancer Institute for cell-based immunotherapy approaches. We provide full services from manufacturing feasibility through process development and clinical manufacturing, with all required regulatory documentation.  

Our program develops and manufactures biopharmaceutical products that commercial manufacturers generally do not, due to process complexity, regulatory hurdles, and/or small market. For instance, we have successfully developed and produced the anti-GD2 ch14.18 monoclonal antibody (commercial name Unituxin®), now the standard of care for pediatric neuroblastoma. 

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    Reach out to our government contact, Dr. Jason Yovandich, NCI Biological Resources Branch, for project inquiries. 

    Collaboration Opportunities

    The Biopharmaceutical Development Program collaborates on projects with the extramural community through the NCI Experimental Therapeutics program (NExT) program. NExT is led by the National Cancer Institute Division of Cancer Treatment and Diagnosis to create a coordinated cancer therapeutics discovery and development pipeline with the extramural scientific community.

    If you are interested in applying or have inquiries about how to collaborate with us, reach out to our government contact, Dr. Jason Yovandich

    History of success

    Since its inception in 1998, the program has manufactured more than 260 lots of 170+ different biopharmaceuticals.

    • More than 260 lots of products released for clinical use 

    • More than 170 distinct biopharmaceuticals manufactured 

    • More than 65 products in human clinical trials 

    • Products successfully tech transferred and two licensed by companies

    • More than 14 products readied for license 

    Additional Content

    Biopharmaceutical capabilities

    Because we work on biopharmaceutical projects not readily conducted in the commercial sector, the program is distinctly structured to handle novel challenges. We determine if a product is well-characterized and ready to translate to manufacturing scale-up for clinical applications. We detect issues in vitro before the product is tested in human subjects. 

    We also provide leading-edge development and analytical technologies.

    Additional Content
    • Antibodies 
    • Antibody Drug Conjugates
    • Recombinant proteins 
    • Peptide, DNA, and viral vaccines 
    • Oncolytic viruses 
    • Gene therapy products 
    • Viral vectors (lentivirus, gamma retrovirus, AAV) 
    • Cell therapies  
    • Other biological and immunomodulating agents