Bovine Virus Diarrhea Vaccine.

CFR · 2024-01-01 · US · Title 9

Bovine Virus Diarrhea Vaccine shall be prepared from virus-bearing cell culture fluids. Only Master Seed Virus which has been established as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine production. All serials of vaccine shall be prepared from the first through the tenth passage from the Master Seed Virus. (a) The Master Seed Virus shall meet the applicable general requirements prescribed in § 113.300. (b) Each lot of Master Seed Virus shall meet the special requirements prescribed in this section. (c) Each lot of Master Seed Virus used for vaccine production shall be tested for immunogenicity. The selected virus dose from the lot of Master Seed Virus shall be established as follows: (1) Twenty-five bovine virus diarrhea susceptible calves shall be used as test animals (20 vaccinates and five controls). Blood samples shall be drawn from these animals and individuals serum samples tested. The calves shall be considered susceptible to bovine virus diarrhea virus infection if the results are negative at a 1:2 final serum dilution in a varying serum-constant virus neutralization test with less than 500 TCID (2) A geometric mean titer of the dried vaccine produced from the highest passage of the Master Seed Virus shall be established before the immunogenicity test is conducted. The 20 calves to be used as vaccinates shall be injected with a predetermined quantity of vaccine virus and the remaining five calves held as uninjected cont

official document · source cfr-2024 · id 9:§ 113.311