Viruses, Serums, Toxins, and Analogous Products; Detection of Extraneous Agents by the Fluorescent Antibody Technique

概要

We are proposing to amend the regulations concerning testing by the fluorescent antibody technique for extraneous agents (viruses) in cells, of animal origin that are used in the manufacture of veterinary biologics. The proposed amendment would allow the use of alternative fluorescent-antibody conjugated antibodies; revised the list of extraneous agents to be tested for; and include extraneous agents for which equine cells are to be tested. The proposed amendment is necessary to update the requirements related to the testing for extraneous viruses.