Cheryl Young, HBsc - Vice President, Business Development and Project Management - Eurofins CDMO Alphora Inc.
Dr. Boris Gorin, PhD - Senior Scientific Advisor - Eurofins CDMO Alphora Inc.
Sushant Dusange - Inside Sales Associate - Eurofins CDMO Alphora Inc.
Tanner Kettles - Senior Manager, Quality Assurance - Eurofins CDMO Alphora Inc.
Is synthetic CBD (Cannabidiol) the future of Cannabis pharma?
Cheryl: We are seeing a growing demand of CBD-based therapies and treatments for a wide range of illnesses and diseases globally. According to a Transparency Market Research report in 2020, the CBD market was valued at US$1.4bn and expected to grow at a CAGR of ~21% from 2020-2030 to ~US$11.3bn.1 Synthetic CBDs are the molecules that mimic the effects of 9-tetrahydrocannabinol (THC), which is the primary psychoactive ingredient in cannabis. Natural CBD derived from the cannabis plant is essentially an agricultural process which has to be isolated from other undesirable cannabinoids such as THC and other impurities such as residual fertilizers and herbicides used to grow the plant. You cannot guarantee the cannabinoid yield will be a 100% pure and efficient. As a result, many pharmaceutical companies are now turning towards synthetic CBD, specifically cGMP- grade CBD. The synthetically derived CBD uses fewer chemicals than solvent and gas extraction and there is low risk of residual impurities. This means each CBD yield will be identical in nature and have the same consistency and purity.
With our cGMP compliant facilities at Eurofins CDMO Alphora, we’re able to provide just that. By applying our rigorous API development expertise, we can synthesize well-characterized, pharmaceutical-grade phytocannabinoids of high purity that can be used for product development, clinical research, reference standards and other applications.
What are the factors driving the CBD market?
Sushant: The health benefits of CBDs are seen primarily in the joint and muscle pain diseases and this has stemmed the rise in the focus of companies capitalizing on CBD products. Another factor that led to the increasing demands for synthetic CBDs is the rise in the prevalence of chronic diseases such as cancer, Alzheimer’s and multiple sclerosis. The use of synthetic CBDs in surgeries and chemotherapies to mitigate the side effects of radiation is also on the rise.
Synthetic CBDs, like Tetrahydrocannabinol (THC) has gained popularity in providing relief from pain and other symptoms without the mind-altering effects of pharmaceutical drugs. CBD is likely to help reduce chronic pain by affecting endocannabinoid receptor activity, reducing inflammation, and interacting with neurotransmitters.
The global synthetic CBD market is divided into high-pure synthetic CBDs and ultra-pure synthetic CBDs. The market was dominated by the high-pure synthetic CBDs segment in 2019 and the trend is projected to continue. These were introduced in the market to treat serious diseases such as epilepsy, insomnia, and multiple sclerosis. Pain management is another major driving factor for the growing popularity in the synthetic CBD market and it dominated the global market in 2019 due to the high rate of incidences of neurological pain which has increased globally due to rise in infections, accidents, or surgeries.
Another driving factor influencing the growth of synthetic CBDs is the regulatory landscape pertaining to the procurement and consumption of synthetic CBDs. R&D is likely to play a key role in promoting awareness of the potential health benefits of synthetic CBDs. The global synthetic CBDs market has been segmented into North America (U.S. and Canada), Europe (U.K., Germany, Spain, Italy, France, and Rest of Europe), Latin America (Brazil, Mexico, and Rest of Latin America), and the Rest of World.
What is the difference between CBD versus CBDv and THC versus THCv?
Sushant: Cannabidivarin (CBDv), is one of many molecules derived from cannabis and hemp plants. CBDv is structurally similar to CBD and like CBD, is not intoxicating when isolated. CBDv has similar health benefits like CBD and is being researched for use in treatments of inflammation, nausea management, seizure reduction, anxiety management, depression management, pain relief and sedation. CBDv was given an “orphan designation”, in 2017, for the treatment of Rett Syndrome by EMEA. Another “orphan designation” was given in 2018, for treatment of Fragile X Syndrome.2
Tetrahydrocannabivarin (THCv) is another cannabinoid that is structurally similar to the psychoactive THC. At high doses, THCvacts similarly to that of THC, as a CB1 receptor (cannabinoid 1 receptor) agonist, however, has much weakened effects. At lower doses, it acts as a CB1 receptor antagonist, meaning it reduces some of the psychoactive effects of THC. THCv is linked to a variety of notable prospects for medical CBD research, especially in appetite suppression and obesity, diabetes, anti-inflammatory and seizure Management.2 At Alphora, we have a worldwide manufacturing license of CBD, CBDv, THC and THCv.
What is our go-to-market strategy?
Sushant: Eurofins CDMO Alphora has an exclusive worldwide manufacturing license for cGMP-grade CBD, THC, CBDv and THCv. Currently we are manufacturing at the lab/pilot scale however we are planning to expand into the plant scale in the fourth quarter of 2021. Our target is to manufacture large quantities of cGMP-grade CBDs and store it for regular and uninterrupted supply to various industries including companies working on alternative medicines, food and beverage and more.
What is the difference between synthetic and natural CBD?
Boris: Synthetic CBD is exactly the same compound as the one isolated from natural sources (Cannabis plants). The major difference of the synthetic CBD product is that it has zero content of other cannabinoids (e.g. THC) that the natural CBD inevitably contains at various quantities for trace amount to ca. 1% due to the specifics of extraction and purification processes used for manufacture of natural CBD.
What is the regulatory landscape for manufacturing synthetic cannabinoids in Canada?
Tanner: In Canada there are several licensable activities related to cannabis including Cultivation, Processing, Analytical Testing, and Research. These activities are governed by the Cannabis Regulations. The Cannabis Regulations cover traditional forms of Cannabis products such as cannabis plants and extracts, but also apply to phytocannabinoids regardless of source (extract orsynthetic). To manufacture synthetic cannabinoids in Canada, a Cannabis Processing Licence is required, and permits the manufacture of any naturally occurring phytocannabinoid. Synthetic Cannabinoids can then be further processed for use in research, medicinal products, and/or cannabis products in accordance with the Cannabis Regulations and the Food and Drug Regulations, as applicable.
Is THCv the new therapy for the treatment of obesity/weight loss?
Sushant: THCv, unlike THC, is not psychoactive at low doses. It dissipates fast and in addition to its cognitive effects, exhibits great medicinal value. THCv has been studied quite well as an appetite suppressant, and can be used as a potential treatment for obesity. Some research indicates that at lower doses (5- 7.5mg), it can reduce appetite by acting as a CB1 Antagonist.3 Some evidence also supports that THCv may be a useful treatment in Type 2 diabetes. A study conducted on type 2 diabetic mice found that THCv was effective in producing increased energy expenditure and reduced glucose intolerance in obese mice [3]. It was also able to increase the insulin sensitivity in these mice [3]. It is quite pertinent though that these anti-obesity and anti-diabetic effects of THCv are only affected at lower doses and at higher doses, it acts like THC and could increase appetite, by acting as a CB1 receptor agonist.
References
- Transparency Market Research (2020, December 18) Synthetic Cannabinoids Market: Increase in Demand for Non-regulated Psychoactive Substances to Drive Market. Medgadget. https://www.medgadget.com/2020/12/synthetic-cannabinoids-market-increase-in-demand-for-non-regulated-psychoactive-substances-to-drive-market.html
- Beadle, A (2021, July 7) CBDV Vs CBD: What Are the Differences? Analytical Cannabis. https://www.analyticalcannabis.com/articles/cbdv-vs-cbd-what-are-the-differences-313186
- Schmidt, E (2020, May 6) A Guide to THCv (Diet Weed): Extraction, Storage, Price, Consumption and More. ACS Laboratory. https://acslabcannabis.com/blog/cannabinoids/a-guide-to-thcv-diet-weed-extraction-storage-price-consumption-and-more/
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