CBD use is expansive and exploding:
Cannabidiol (CBD), is a non-psychoactive phytochemical that is the second most prevalent constituent of the cannabis plant, and its use for a myriad of purported health benefits is expanding exponentially. Today, 1 in 7 US consumers are using plant-based CBD for pain relief, improved sleep, anxiety and other maladies, while clinical research continues in a broad range of symptoms and diseases (1,2).
CBD is readily available to consumers as plant-derived extracts, oils, lotions, tinctures, and edibles. There are currently three methods of producing cannabinoid extracts: hemp-based extraction, biosynthesis and organic synthesis, with significant differences among them. As we discuss each below, bear in mind that the exploding demand for CBD products across all three market segments – wellness, medical and pharmaceuticals - is driving increased demand for higher standards of quality, purity, and scalability (3). Hemp-based production has insurmountable limitations. Hemp-based extraction is today the most commonly used method of cannabinoid production. However, despite the FDA’s recent classification of CBD as a Schedule V drug with a relatively low risk of abuse, the consumption of products containing hemp-based CBD is not without risk, due to wide variations in quality, consistency and efficacy. To illustrate: a recent report from Bonn-Miller, et.al has documented the vast range of CBD concentrations among hemp-derived CBD products purchased online, underscoring the “wild card” aspect of hemp-based CBD products sourced from multiple, unregulated sources (4).
The variability inherent in hemp-derived CBD, driven by unpredictable and constantly changing harvesting time schedules, weather, soil and farming conditions, has eliminated its utility as a means of large-scale CBD production. Per Raymond James in a recent investor publication: “…this variability makes plant-derived cannabinoids completely unusable on the manufacturing lines of large-scale, low-tolerance global players (5).”
Biosynthesis vs. organic synthesis production – both alternatives, but which is best?
Companies that recognize the commercial opportunities of products derived from pure, predictable CBD have looked to other, non-plant based production approaches as a means to overcome the limitations of hemp-based CBD.
Biosynthesis a process that utilizes genetically modified (GMO) living organisms, such as yeast and e-coli, to produce CBD through fermentation, has been viewed as a viable alternative to hemp-based production, and has captured a significant amount of venture capital as the demand for standardization of CBD has escalated.
However, while a definite improvement over the hemp-based approach, biosynthesis does not resolve the critical issue of consistency because it still uses living organisms. There are also additional negatives that inhibit capture of market share, including the difficult-to-control fermentation process - how organisms grow, extraction of CBD from the cells, waste elimination, and the low amount of CBD produced from batch-to-batch – and significant capital investment for real estate and equipment costs.
While a number of companies in the biosynthesis space have been pursuing remedies for these obstacles, efforts to scale the process to the tons scale have not been successful.
Organic synthesis is a special branch of chemical synthesis that uses non-biological agents. It enables the construction of organic compounds in the laboratory, without fermentation, thus eliminating the variables inherent in biological agents, while offering high-yield capacity for a significantly lower capital investment. This process, which takes off-the-shelf chemicals and combines them to create CBD and other cannabinoids, has a demonstrated superiority to all other known methods for many small molecule therapeutics and pharmaceuticals.
An example is Tarceva, a treatment for non-small-cell lung cancer from the pharmaceutical giant Roche/Genentech. Despite their massive skill and capacity in biosynthesis, Roche/Genentech identified organic synthesis as the preferred method to produce Tarceva because of its ability to deliver high-quality and consistency at a very low-cost (6). Other organically synthesized products now in everyday use include Splenda (Sucralose) made by substituting three OH groups on the sucrose (natural cane sugar or beet sugar) molecule with Chlorine using organic synthesis. Sucralose is the clear winner in the global substitute sugar industry, a market forecasted to reach a value of $21.5 billion by 2026 (7).
Scalable and consistent organic synthesis is the answer to large-scale CBD production
For the developers of natural products, consistency, safety and scalability of the production process have always been the main drivers. Organic synthesis offers the opportunity to develop cost-effective and consistent formulations of CBD in a scalable way, and has been identified by investment firm Raymond James as “…the only truly commercial alternative modality for large-scale production of pure cannabinoids...(6)"
Nalu Bio is creating a new category of CBD through a proprietary organic synthesis methodology that offers the duel benefits of safety and scalability. Our straightforward, lab-based approach uses known chemistries and existing materials to produce high-quality, low-cost, and therapeutically predictable cannabinoids each time, and every time. Manufacturing chemical products in the lab may not be new, but it’s new for cannabinoids, and will drive Nalu Bio’s development of a reliable and cost-effective synthetic source of CBD – a breakthrough that will unleash the full therapeutic potential of CBD.
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4. Bonn-Miller MO, Loflin MJE, Thomas BF, Marcu JP, Hyke T, Vandrey R.Labeling Accuracy of Cannabidiol Extracts. JAMA November 7, 2017 Volume 318, Number 17
5. Sarugaser R, Freeman M, Biosynthesis of Cannabinoids: Vanguard of the Bio Revolution. ©2020 Raymond James & Associates
6. Barghi L, Aghanejad A, et al., Modified Synthesis of Erlotinib Hydrochloride. Advanced Pharmaceutical Bulletin, 2012, 2(1),119-122
8. Sarugaser, Biosynthesis of Cannnabinoids