Abstract

Most biopharmaceuticals are currently made at great expense in fermentation vats containing bacteria or mammalian cells. But the mass production of medicines in genetically modified plants, first proposed in 1989 could reduce costs and therefore make an important contribution to global health, particularly in developing countries. A major bottleneck for the technology has been widespread scepticism that recombinant proteins could be manufactured in plants to the same standard and quality as current conventional systems. Developing a robust and reproducible manufacturing process for plants has therefore been an important priority for the field, an achievement that was reached earlier this year in Europe. This talk will describe the rationale for developing GM plants for pharmaceutical production, the development of a manufacturing process that was approved by medicines regulators, leading to a first-in-human clinical trial and discuss the future for Molecular Pharming.