In the United States, Transgenic plants including but not limited to those which produce pharmaceuticals, are regulated by three government agencies which comprise the Coordinated Framework for Regulation of Biotechnology established in 1986. Conventional production methods for pharmaceutical proteins involve substantial investments of both time and finances. Not only are there manufacturing challenges involved with conventional production methods, plant-made pharmaceuticals could save substantial time, money, and provide a system for producing proteins that could solve current production challenges. When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug must satisfy the "current Good Manufacturing Practices" regulations of the FDA. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles. One approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk (or blood or urine). Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome.[1] The first such drug manufactured from the milk of a mammal, such as a cow, sheep, or goat, is a common application, as milk production is plentiful and purification from milk is relatively easy. Hamsters and Rabbits have also been used in preliminary studies because of their faster breeding. Companies.