Requirements for cell lines used for production of biologics.

CFR · 2024-01-01 · US · Title 9

When prescribed in an applicable Standard Requirement or in a filed Outline of Production each cell line used to prepare a biological product shall be tested as prescribed in this section. A cell line found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a cell line that is found unsatisfactory by any prescribed test. (a) (2) A Master Cell Stock (MCS) shall be established at a specified passage level for each cell line. The passage level and identity of the MCS and the highest passage level (MCS + n) intended for use in the preparation of a biological product shall be specified in the Outline of Production for the product. (3) Sufficient 1.0 ml or larger aliquots of MCS and MCS + n shall be prepared, kept in a frozen state, and made available to Animal and Plant Health Inspection Service (APHIS) upon request for performing the tests prescribed in this section. (4) Each lot of cells shall be monitored for the characteristics determined to be normal for the cell line, such as, but not limited to, microscopic appearance, growth rate, acid production, or other observable features. (b) The MCS shall be shown to be of the same species of origin as that reported in paragraph (a)(1) of this section by the following method: (1) At least four monolayers with a total area of at least 6 cm (2) The monolayers shall be removed from their media, processed, stained, and examined. (i) At least two monolayers shall

official document · source cfr-2024 · id 9:§ 113.52