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WebJun 2, 2024 · The regulations commonly known as the Animal Rule (21 CFR 314.600-650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002) allow for the approval of drugs and licensure of biological ... WebMar 24, 2015 · Defense (6, 7), and RiVax, developed at the University of Texas Southwestern (8–11). RiVax is a recombinant RTA with two mutations (V76M, Y80A) that eliminate both its enzymatic ac-tivity and its ability to induce vascular leak syndrome in humans (8, 12). The crystal structure of RiVax is virtually identical to that WebBoth RiVax (Smallshaw et al., 2005, 2007) and RTA 1–33/44– 198 (Olson et al., 2004) elicit neutralizing antibodies that protect animals against ricin exposure, but may differ in their complement of epitopes. To characterize RiVax produced from a large-scale manu-facturing run and compare it with RTA and related immu- pare topoisomerase