Molecular farming - The slope of enlightenment.

Molecular farming can be defined as the use of plants to produce recombinant protein products. The technology is now >30 years old. The early promise of molecular farming was based on three perceived advantages: the low costs of growing plants, the immense scalability of agricultural production, and the inherent safety of plants as hosts for the production of pharmaceuticals. This resulted in a glut of research publications in which diverse proteins were expressed in equally diverse plant-based systems, and numerous companies were founded hoping to commercialize the new technology. There was a moderate degree of success for companies producing non-pharmaceutical proteins, but in the pharmaceutical sector the anticipation raised by promising early research was soon met by the cold hard reality of industrial pragmatism. Plants did not have a track record of success in pharmaceutical protein manufacturing, lacked a regulatory framework, and did not perform as well as established industry platforms. Negative attitudes towards genetically modified plants added to the mix. By the early 2000s, major industry players started to lose interest and pharmaceutical molecular farming fell from a peak of expectation into a trough of disillusionment, just as predicted by the Gartner hype cycle. But many of the pioneers of molecular farming have refocused their activities and have worked to address the limitations that hampered the first generation of technologies. The field has now consolidated around a smaller number of better-characterized platforms and has started to develop standardized methods and best practices, mirroring the evolution of more mature industry sectors. Likewise, attention has turned from proof-of-principle studies to realistic techno-economic modeling to capture significant niche markets, replicating the success of the industrial molecular farming sector. Here we argue that these recent developments signify that pharmaceutical molecular farming is now climbing the slope of enlightenment and will soon emerge as a mature technology. Published by Elsevier Inc.