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Products Derived from Characterized Cell Banks Which Were Subsequently Grown In Vivo
For products manufactured from fluids harvested from animals inoculated with cells from characterized banks, additional information regarding the animals should be provided.
Whenever possible, animals used in the manufacture of biotechnological/biological products should be obtained from well defined, specific pathogen-free colonies. Adequate testing for appropriate viruses, such as those listed in Table 3, should be performed. Quarantine procedures for newly arrived as well as diseased animals should be described, and assurance provided that all containment, cleaning, and decontamination methodologies employed within the facility are adequate to contain the spread of adventitious agents. This may be accomplished through the use of a sentinel program. A listing of agents for which testing is performed should also be included. Veterinary support services should be available on-site or within easy access. The degree to which the vivarium is segregated from other areas of the manufacturing facility should be described. Personnel practices should be adequate to ensure safety.
Procedures for the maintenance of the animals should be fully described. These would include diet, cleaning and feeding schedules, provisions for periodic veterinary care if applicable, and details of special handling that the animals may require once inoculated. A description of the priming regimen(s) for the animals, the preparation of the inoculum, and the site and route of inoculation should also be included.
The primary harvest material from animals may be considered an equivalent stage of manufacture to unprocessed bulk harvest from a bioreactor. Therefore, all testing considerations previously outlined in section IV. of this document should apply. In addition, the manufacturer should assess the bioburden of the unprocessed bulk, determine whether the material is free of mycoplasma, and perform species-specific assay(s) as well as in vivo testing in adult and suckling mice.