Nonclinical Testing for Oncology Biologic Products

Abstract

Different statutes govern the regulation of drug and biologic products in the United States. Whereas both are subject to the Food, Drug, and Cosmetic Act of 1948, biologic products are mainly regulated by the Public Health Service Act of 1944. The differences in the regulation of drug and biologic products are mainly owing to the basic premise that most drug products have a known structure and are chemically synthesized, whereas biologic products are derived from living sources (such as humans, animals, plants, and micro-organisms), may not have a completely defined structure, tend to be heat-sensitive, and are prone to microbial contamination. According to the regulations, a biologic product is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of disease or injuries to humans (http://www.fda.gov/cber/faq.htm) (1). Oncologic products classified as biologics include preventative and therapeutic vaccines, somatic cell and gene therapy, monoclonal antibodies, immunotoxins, radioimmunotherapy, recombinant proteins (e.g., cytokines, growth factors, and fusion proteins), and most other biotechnology-derived products.