Sabin Vaccine Development Capabilties

With ten years of experience, Sabin Vaccine Development has produced a well-rounded model that serves as a blueprint for the development of safe and effective vaccines against vaccine preventable and neglected tropical diseases. Existing capabilties include:

• Product Development: Established the infrastructure to engage in antigen discovery, rapid development of scalable manufacturing processes (process development), quality control, preclinical and clinical immunology and stability testing.

• Technology Transfer and Manufacturing: Work with manufacturers in both Brazil and the United States to scale up developed processes for manufacture of pilot clinical lots under current good manufacturing practices (cGMP).

• Epidemiological and Clinical Studies: Established a field laboratory and field clinical site, including a vaccine testing center in the endemic region of Americaninhas in the Brazilian state of Minas Gerais, for the conduct of clinical trials, including Phase 1 (first in human trials).

• Ethical and Regulatory Approvals: Completed Phase 1 clinical trials with ethical oversight from institutional review boards in the United States and Brazil and obtained regulatory approval for clinical testing from the U.S. Food and Drug Administration (FDA) and Brazilian regulatory agency, the Agencia Nacional de Vigilancia Sanitaria (ANVISA).