Biopharmaceutical Development Program

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. 

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.