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Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
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Regulation of autogenous biologicals in the United States
C S Schmellik-Sandage1, R E Hill
1Center for Veterinary Biologics, USDA, Animal and Plant Health Inspection Service, Veterinary Services, Ames, IA 50010, USA.
Abstract:
The U.S. Department of Agriculture's Center for Veterinary Biologics (CVB) is charged with protecting American agriculture. As part of this effort, CVB licenses manufacturers to produce special biologics for use in individual flocks or livestock herds afflicted by a particular microorganism. These special products, autogenous biologicals, are inactivated vaccines used by or under the direction of a veterinarian or USDA-approved specialist and are produced under a variety of special licensing requirements.
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