By Dr Guy Tropper, Executive Vice President, Co-Founder
Biologics, a class of medications made of complex proteins have come to widespread use in the past two decades, changing the lives of millions of people with cancer, autoimmune and a host of other illnesses. Among these, all with a generic name ending in “…mab.” Until now, these have been manufactured in large sterile tanks providing a very controlled environment for bacteria, fungi and other types of cells tasked with producing such biopharmaceuticals. mRNA-based vaccines are also produced using such “bioreactors.” It takes years, a lot of people with special expertise and considerable financial investments to set-up manufacturing sites using such technology for a limited range of biologics. These factors certainly play a role in the often eye-watering cost of medications of this kind.
Taking advantage of plant versatility
Another approach to the production of such “biologics” takes advantage of the versatility of plants. We have learned a lot in the past 30 years about how to better harness the power of plants in this regard. Sophisticated knowledge of plant cell biology has brought the opportunity of uniquely competitive advantages in biomanufacturing. More recent techniques of such plant-based manufacturing use a process called “transient expression” where plant leaves are purposefully “transfected”, a term to describe temporary genetic instructions to prompt the biology of plant cells to produce the desired biologic.
- Flexible batch size. Indeed, the batch size can be adjusted to the specific needs. Early-stage biotech companies may need only a few plants, if all that is needed is a small amount of the prototype-medication for preliminary assessments (proof-of-concept). The order is not compelled to a minimum because the bioreactor can only deliver the desired candidate biologic in a fixed, often large, quantity.
- Quick turnover. The 5 to 6 day “production” period between the transfection process and the harvesting of the biologics is short in comparison to bioreactor-based production and allows biotech companies to adjust the target medication through rapid iterations. Time is money! And small biotech companies are always under pressure to develop their products rapidly as this gives them more latitude to advance them through testing. Also, we have seen acutely during the recent COVID pandemic, the importance of our being able to generate candidate-medications – vaccines on an urgent basis. Quick turnover time and easy, rapid scalability are other remarkable attributes of plant-based biomanufacturing which make it strategic even if underused still.
- Easy scalability. An ever-increasing number of biologics are being developed for an ever-increasing number of disease conditions touching hundreds of millions of people. The delay in ordering, constructing and setting up the large foot-print manufacturing installations required are significant challenges the pharma industry has to contend with. By contrast, plant-based manufacturing can be easily scaled up. Since the bioreactor is always the same, an unmodified plant, just add plants! With plant vertical stacking in controlled environments, the entire process can meet the rigorous standards required of pharmaceutical production yet adapt rapidly to increasing demand.
- Financial competitiveness. Peer-reviewed scientific technico-economic analysis have compared both approaches to biomanufacturing. These have shown how both the initial cost of setting up a production plant (CAPEX) and its subsequent operation (OPEX) favor plant-based approaches. The latter is also competitive if you consider the manpower required and the carbon footprint.
Large pharmaceutical companies have so far tended to favor bioreactor-based approaches to biomanufacturing on the basis of past experience and reliability. The pharmaceutical industry as a whole is known to be rather conservative and significant technological changes are established slowly. It will take young, savvy biotech companies like ANGANY to come up with their own products brought to commercial success before the industry as a whole takes a more attentive look at the strategic importance of plant-based biomanufacturing. The pressure to provide an ever-wider range of medications while keeping these accessible will inexorably bring us to this technological transition.