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.
Manufacturing clinical materials to support advancement of novel vaccines, biologics targeting infectious diseases
In the 10-year period 2014-2024, we completed more than 347 shipments supporting approximately 110 clinical trials across 49 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.
Antibody manufactured at Frederick National Laboratory received FDA approval to treat Ebola virus disease
A complete life cycle for clinical materials
Manufacturing
Provides cGMP manufacturing capabilities from bacterial/mammalian cell banking through purified drug substance to the final, vialed drug product. Manages technology transfers for a variety of processes including transient transfection, recombinant glycoproteins, monoclonal antibody, self-assembling nanoparticles, and conjugated fusion peptides.
Quality Control
Oversees the testing of all raw materials; in-process manufacturing samples; final release testing for cell banks, drug substances, and drug products; microbiology samples, including environmental monitoring and utility sampling; and stability of drug substance and drug product.
Quality Assurance and Regulatory
A mission centered group chartered with establishing and maintaining the required procedures, tools, and organizational structure necessary to support an effective quality system.
Scientific Programs and Subcontracts
Delivers programmatic support to the NIH/NIAID Vaccine Research Center by overseeing projects related to vaccine and therapeutic development. The group provides project management oversight for Task Orders with the Vaccine Research Center as well as technical oversight for work performed by Subcontracting institutions.
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.
Investigational products developed to improve health
Our capabilities and specializations
Investigational products and platform technologies
Our program manufactures and supplies several investigational products using different platform technologies to tackle current, emerging, and re-emerging diseases caused by viruses or parasites such as HIV, Ebola, equine encephalitis, influenza, Plasmodium falciparum, respiratory syncytial virus, and Zika virus.
Recombinant glycoproteins
Monoclonal antibodies
Mosaic multi-component nanoparticles
Peptide-conjugate vaccines
Virus-like particles
Plasmid DNA (pDNA)
Recent contributions to public health and exploratory medicine research
Anti-Malarial Antibody (L9LS)
- Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria
- Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria
Influenza
- Phase 1 dose-escalation trial evaluating a group 2 influenza hemagglutinin stabilized stem nanoparticle vaccine
- An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults
HIV Antibodies
- Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial
- Safety and pharmacokinetics of escalating doses of neutralizing monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomized controlled trial
- Extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women: study protocol for the randomized, placebo-controlled double-blinded, phase 2 CAPRISA 012C trial
- Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial
