The Vaccine Clinical Materials Program (VCMP) produces clinical-stage vaccine candidates for infectious diseases of global significance.
Key activities include procurement services for research/development, technology transfer of manufacturing processes and analytical methods, and scientific subcontracting. The program manufactures pilot-scale good manufacturing practice (GMP) products to distribute to clinical sites around the world, conducts product release and stability testing, and provides regulatory support and inventory and supply of a range of vialed drug products.
VCMP is engaged in multiple programs including HIV/AIDS broadly neutralizing antibodies, influenza nanoparticles, malaria and tuberculosis vaccine development, as well as emerging and re-emerging diseases like Zika.
Most recently, VCMP has supported rapid response to global health threats posed by the Zika virus and chikungunya. In 2016, the program developed an accelerated schedule to produce, test, and release a Zika vaccine candidate in just 90 days. Also, since 2016, the program has completed several batches of Zika vaccine vialed drug product (DP) and physical drug substance (DS) totalling roughly 10,000 vaccine doses. VCMP is also involved in a clinical trial for an experimental vaccine for mosquito-borne chikungunya, for which there is no treatment or vaccine.
- Zika Phase 1 Clinical Trial Material- From Research to Release in 90 Days
- Frederick National Lab Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya