Everything changed in the pharmaceutical world in 1978. . .
That was the year researchers modified the genes of a common bacteria to produce human insulin. By inserting human DNA containing genetic code for insulin production, the world's first biologic therapy was created. By the early 1980s, synthetic insulin became commercially available, and it transformed the diabetes market.
Since that time, biologics, or drugs created from biological processes, have revolutionized medicine. Today, seven of the world's top 10 best-selling drugs are biologics, with the top three slots occupied by this category of therapeutic compounds.
Why have biologics been so successful? Large therapeutic molecules, such as engineered antibodies and synthetic versions of human hormones, require the use of custom-tailored organisms. The ability to harness the power of the genome to produce lifesaving drugs has allowed drug companies to create therapeutic molecules too complex for traditional chemistry. As a consequence, the biomanufacturing revolution has opened new avenues for treating disease.
Still, improvements could be made. Biologic compounds tend to be far more expensive to manufacture than their small molecule counterparts.
The early biologics, such as insulin and human growth hormone, are produced with simple organisms like E. coli bacteria. More complex proteins, however, require more complex forms of life to enable production. Since 1987, the mainstay of the biotechnology industry for these kinds of therapeutics has been cell lines derived from Chinese hamster ovaries (CHOs) and other rodent cells.
While cell lines from simple organisms like bacteria tend to be relatively inexpensive to grow in culture, this is not the case for mammalian cell lines. CHO cells require carefully monitored conditions and many expensive inputs in order to yield acceptable quantities of product. While enabling a new generation of lifesaving therapies, this fact is partly responsible for the high cost of many new wonder drugs.
But recently there has been a new technological focus in biomanufacturing. It is the use of plant cells, instead of mammalian cells, to produce biologics. This plant-based platform is a whole new way to manufacture therapeutic proteins. Rather than using mammalian cell lines as a genetic engineering platform to produce human proteins, this technology uses cells derived from plant species such as carrot or tobacco.
Like mammalian cells, plant cells are genetically modified to manufacture a protein scientists are interested in producing. They don't actually grow carrots or tobacco, however. It builds a stable cell line from these plants that produce the desired protein. Once created, they can replicate it indefinitely.
When needed, the cells are cultured in a unique bioreactor system meeting regulatory standards for the production of human therapeutic proteins. With this plant-based technology, formerly expensive therapeutic proteins can now be manufactured in very cost-efficient, flexible polyethylene bags. . .
Nonmammalian, plant-based biomanufacturing also has a very big advantage in safety. With mammal cell lines, the potential always exists for a viral infection that can taint the end product. If it so happens that there is a viral infection in the growth culture, it could be potentially transmitted to patients, since the drug is made by these cells.
Unlike mammal cells, however, humans are immune to infectious diseases that affect plant cells, and mammalian viruses do not infect plants. Using a plant cell system is like having a biological firewall that protects against the transmission of infectious organisms to patients via the therapeutics.
This is a truly groundbreaking technology. For decades, we have been using mammalian cells because it was the only available technology that could produce complex proteins. Some of these drugs, however, can cost over $100,000 per year. Being able to manufacture the product far more cheaply creates the potential for a greater population of patients to afford access to lifesaving, protein-based therapies. Wise investors will keep their eye on this one. . .
Yours for transformational profits,
Patrick Cox
The Penny Sleuth
