Detection of extraneous viruses by the fluorescent antibody technique.

CFR · 2024-01-01 · US · Title 9

The test for detection of extraneous viruses by the fluorescent antibody technique provided in this section shall be conducted when prescribed in an applicable Standard Requirement or in a filed Outline of Production for a product. (a) Monolayer cultures of cells (monolayers), at least 7 days after the last subculturing, shall be processed and stained with the appropriate antiviral fluorochrome-conjugated antibody as specified in paragraph (b) of this section. (1) Three groups of one or more monolayers shall be required for each specific virus prescribed in paragraph (b) of this section. (i) At the time of the last subculturing, one group of test monolayers shall be inoculated with approximately 100-300 FAID (ii) One group of monolayers shall be the “material under test.” (iii) One group of monolayers, that are of the same type of cells as the test monolayers and that have been tested as prescribed in §§ 113.51 or 113.52 (whichever is applicable), shall be prepared as negative controls. (2) Each group of monolayers shall have a total area of at least 6 cm (3) Positive control monolayers may be fixed (processed so as to arrest growth and assure attachment of the monolayer to the surface of the vessel in which they are grown) before 7 days after subculturing if fluorescence is enhanced by doing so, (b) The antiviral fluorochrome-conjugated antibodies to be used shall depend on the type of cells required to be tested for extraneous viruses as specified in an applicable Standard

official document · source cfr-2024 · id 9:§ 113.47