Drug Regulators, FDA, Publish Guidance on Characterisation and Qualification of Cell Substances and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Diseases.
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The, FDA, are providing manufacturers of viral vaccines, with guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use.
This guidance applies to the development of viral vaccines for the prevention and treatment of infectious diseases that are regulated by the Office of Vaccines Research and Review (OVRR) of the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262).
Cell substrates are cells used to produce vaccines. The scope of this guidance document is limited to cell substrates of human or animal (including insect) origin and does not cover characterization of unicellular organisms, such as bacteria or yeast. In this document, cell substrates are categorized as primary (cells, including eggs, derived directly from an animal source and that are not stored as cell banks), diploid (cells with a normal or near-normal karyotype and that are stored as cell banks prior to use in vaccine manufacture), or continuous (cells that are immortal and do not undergo senescence). This guidance also applies to the characterization and qualification of viral seeds and other biological materials (including vaccine intermediates) used in vaccine manufacture.
This guidance finalizes the draft guidance entitled “Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,” dated September 2006 (71 FR 57547). In addition, this document replaces the information pertaining to viral vaccines for the prevention and treatment of infectious diseases that we provided in the document entitled “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993 (Ref. 1). This document also supplements the recommendations on the production of viral vaccines for the prevention and treatment of infectious diseases, provided in International Conference on Harmonization (ICH) documents Q5A and Q5D (Refs. 2 and 3, respectively). For the production of biological products not covered under this guidance, we recommend that you refer to the “Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals,” dated 1993 (Ref. 1).
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