Location: Biologics Development Module
Project Number: 3022-32000-026-003-S
Project Type: Non-Assistance Cooperative Agreement
Start Date: Sep 1, 2023
End Date: Aug 31, 2024
Objective:
African Swine Fever virus (ASFV) is a virus which causes a hemorrhagic fever with high mortality rates in domestic pigs; some isolates can cause death as quickly as a week after infection. A vaccine is needed to protect swine herds from this virus. In order to create a vaccine, a master seed virus (MSV) must be produced in clean, uninfected, permissive cells. A master seed that is produced in a Good Manufacturing Practices (GMP) facility will be able to be shared with stakeholders around the world. The MSV will be produced in a BSL-2+ facility with shower-out capability, according to regulations outlined in 9 CFR and in accordance with GMP. The MSV will be sent to the Center for Veterinary Biologics (CVB) for confirmatory testing and approval, as well as other international regulatory agencies.
Approach:
Task 1. Cooperator will receive a Veterinary Services (VS) permit for African Swine Fever (ASF) vaccine candidate strain.
Task 2. ARS will send Cooperator ASF vaccine strain and primary swine macrophage cells.
Task 3. Cooperator will prepare BSL-2+ facility for master seed production, including all needed equipment and materials and ensure facility receives GMP certification.
Task 4. ARS will produce GMP-compliant candidate master seed virus (MSV) in GMP facility.
Task 5. Cooperator will store MSV and transfer entire inventory to ARS upon request.
