The technologies involved in producing a protein by biotechnological processes have been widely documented and general guidelines have been established by the federal government. The products of biotechnology may be regulated as drugs, biologics, or diagnostics, depending on their source, composition, and intended use. The novel approaches permitted by biotechnology can make it difficult to apply classic definitions of these categories and FDA has advised manufacturers to seek clarification in the early stages of development for how a product will be regulated when classification is not obvious.1
The overall regulatory scheme for biotechnology-derived products is the same as for products in the same category produced by traditional manufacturing methods, with the addition of specific requirements suited to the biotechnology-derived product. The general requirements are described primarily in the applicable parts of the Code of Federal Regulations, Title 21. NIH has published a guideline for rDNA research that is mandatory for both public and private NIH-supported research. This guideline has wide acceptance and voluntary compliance is common by institutions and corporations not specifically governed by it.2
Laboratory safety practices, particularly protection from potentially infectious materials, are a concern.3
Producing macromolecular articles by biotechnological processes involves initially the cloning of a specific gene in the laboratory, or the construction of a synthetic gene, with subsequent insertion into a host cell and subcloning in a microorganism or cell culture; then a process development on a pilot scale to optimize yield and quality; and finally large-scale fermentation or cell culture processes. The next step, which is the most relevant to the development of compendial monographs, is the purification of the macromolecular proteins. This is followed by animal testing, clinical testing, regulatory approval, and marketing.