Vaccine Clinical Materials Program

The Vaccine Clinical Materials Program supports the National Institute of Allergy and Infectious Diseases Vaccine Research Center in the development, production, and supply of investigational-phase biologics and/or vaccine candidates to address infectious diseases of global importance. The program is responsible for the operation of the Vaccine Pilot Plant located in Frederick, Maryland. 

We manufacture and supply NIAID with a variety of traditional and novel vaccine technologies and biologics such as DNA, virus-like particles, peptide carrier protein conjugates, nanoparticles, mosaic multi-component nanoparticles, monoclonal antibodies (mAbs), and adjuvants. for evaluation in clinical trials conducted in the U.S. and globally. Targets include HIV, malaria, and Ebola virus disease. Our program manufactures alum-based adjuvants.  

In the 10-year period 2012-2022, we completed over 300 shipments supporting approximately 100 clinical trials across 45 products. Our products have been administered to thousands of patient volunteers in U.S. and global clinical trials. 

We are committed to the highest standards of product safety and quality. We provide a complete life cycle for clinical materials from cell banking, drug substance, and drug product filling and testing. 

Through our versatile and flexible program, we quickly accelerate manufacturing of novel vaccine candidates, provide testing for ensuring the quality and safety of drug product, provide technical content for chemistry, manufacturing, and controls section of new Investigational New Drug applications, deliver materials to clinical trial locations, and provide on going stability analysis.

 Our program: 

• Handles procurement services for research and development. 
• Manages subcontracting of preclinical and Phase I–enabling studies with academia and industry. 
• Oversees technology transfer of cell-culture/fermentation manufacturing processes and analytical methods from the Vaccine Research Center’s Vaccine Production Program to the Frederick pilot plant, along with qualification and validation of test methods. 
• Manufactures drug substances and formulates vialed drug products under current Good Manufacturing Practices (cGMP). 
• Performs lot release and stability testing; provides regulatory support and content input (chemistry, manufacturing, and controls) for Investigational New Drug applications and Drug Master Files sponsored by the National Institute of Allergy and Infectious Diseases. 
• Provides controlled-temperature unit storage of starting materials, intermediates, and final products. 
• Provides quality assurance for release and supply of a wide range of Phase I/II clinical materials (including placebos and adjuvants) to sites in the U.S. and across the world for planned and/or ongoing clinical trials.