USDA licensing policy for biologicals produced by R-DNA

The advent of recombinant DNA technology has prompted a review of current Standard Requirements used in licensing Veterinary Biological Products. Unique problems associated with the production and testing of biologics derived from the new biotechnology are reviewed to insure compliance with the United States Department of Agriculture's requirement for purity, safety, potency and efficacy. Requirements for plasmid/vector characterization and stability will be discussed and correlated with the Master Seed concept. Practical methodology used to monitor antigenic expression, concentration, purification and stability during production and recovery is considered. Bulk and/or final container testing will meet established criteria for biologicals produced by conventional procedures. Experience in preparation and regulation of recombinant-derived biologicals may require revision of current Standard Requirements or special additional requirements. This flexible approach will facilitate licensing of these new products.