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, testing, release and supply of Phase I/II clinical materials for first-in-human studies. Our facility upholds Current Good Manufacturing Practice (CGMP) regulations in its operations.
We produce high-quality, sterile, vialed drug products and provide content input. Disease targets and associated products we work on include:
- Glycoprotein trimer vaccines
- Peptide conjugate vaccines
- Multi-valent nanoparticle vaccines
All production is done by fermentation and/or mammalian cell culture in 50 -2000 liter bioreactors.
We conduct analytical stability on all our products, distribute clinical products in the U.S. and internationally, and manage all product inventory on behalf of the Vaccine Research Center in the National Institute of Allergy and Infectious Diseases. We procure services and supplies for the Vaccine Research Center to support early research and development, enable external transfer of processes and methods to licensees, and facilitate pre-clinical work under subcontracts at several universities and companies.
Our products have been administered to thousands of patient volunteers in U.S. and global clinical trials.