New discoveries involving therapeutic proteins, such as monoclonal antibodies to treat various types of cancer, offer exciting and promising hope for a range of diseases. However, there are challenges to producing these therapeutic proteins safely, economically, and in quantities that can be adjusted to meet growing needs. Current production methods include reproducing the target protein through cell culture or bio-fermentation processes; expressing the protein in genetically altered animals, or growing the proteins in plants also modified using modern biotechnology.
Current Production Challenges
Conventional cell culture methods require significant amounts of both time and money, and their ability to produce the complex molecules that are central to pharmaceutical treatments for many diseases is limited. It is estimated that cell culture manufacturing facilities cost between $250 million and $450 million and have construction times in excess of 3 years. Furthermore, they must be individually approved and certified by the Food and Drug Administration before full-scale operations can commence. Animal production challenges include the need to manage virus- and prion-transfer risks. Plant-based production, meanwhile, requires implementing current good-manufacturing laboratory-practice standards (cGMP) for containment.
Today, with 30 protein-based medicines on the market and close to 100 in late-stage human trials, there is a need to provide a range of options for production of the simple and complex molecules that are the backbone of these medical treatments.
The promise of PMPs
Plant-made pharmaceutical production may be one solution to the need to manufacture proteins for these medicines in a manner that is easily scaleable, safe and cost-effective. In this process, plants become factories that manufacture therapeutic proteins. These proteins are then extracted, refined, and used as the active ingredient in a pharmaceutical application.
In comparison with conventional production methods this process could save substantial amounts of time and money, enable more-easily scaleable production, and provide the ability to produce complex proteins that current systems. may not be able to produce.