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Sharon A. Berberich

Articles

US Regulation of Plant-made Biopharmaceuticals, Part 2

In the first part of this feature (Jan. 2005) we discussed the technical background and the role that FDA, US Department of Agriculture (USDA), and Environmental Protection Agency (EPA) play in setting the rules for accepting plant-made biopharmaceuticals (PMBs). We now continue by discussing how producers will be able to take products to market.

US Regulation of Plant-made Biopharmaceuticals, Part 1

Transgenic plant systems promise lower production costs since plants can be grown in a field instead of a cell-culture facility. Also, they provide an alternative production system for proteins that are difficult to express in cell culture.