Noramco and Willow Biosciences to jointly develop a biosynthesis platform for synthetic CBD

05 Jun 2019 --- Cannabinoid (CBD) manufacturer Noramco and Willow Biosciences, a developer of biosynthetic production systems for plant-derived active pharmaceutical ingredients (APIs), will collaboratively develop a yeast-based biosynthesis platform for the production and distribution of CBD. Within the exclusive Joint Development Agreement (JDA), Willow Biosciences will be responsible for optimizing yeast strains in a biosynthetic process that will generate “ultrapure” CBD at high yield and a substantially lower cost compared to current methods. Because of its existing expertise in the production of CBD and related compounds, and experience in delivering these in clinical and pharmaceutical applications, Noramco will be responsible for scale-up, regulatory submission, marketing and distribution.

“The addition of biosynthetic CBD production will augment Noramco’s ability to work with our existing customers and the capacity to address the rapidly increasing market demand for CBD based APIs and ingredients from pharmaceutical, nutraceutical, consumer packaged goods, beverage and other industry sectors. We are excited to be working with the world-class team at Willow and are confident in their ability to deliver scalable, CBD-producing strains to Noramco,” notes Bill Grubb, Noramco’s Chief Innovation Officer and VP Global Business Development.

The hemp CBD market is booming, and totaled US$190 million in 2018 – an astounding rate of growth for a category that did not even exist five years ago, according to The Hemp Business Journal estimates. Although sales are projected to grow over the coming years, legal uncertainties surrounding the compound may lead to an increased interest in synthetic sources.

The technology platform biosynthesis will be used to provide a low-cost, ultra-pure and scalable manufacturing solution for pharmaceutical, food, beverage and personal care consumers of CBD. The work conducted in the JDA reportedly has the potential to open new and larger markets for CBD and related compounds.

 Legal uncertainties surrounding CBD from hemp could lead to an increased interest in synthetic sources.The parties will cover their respective costs, retain the intellectual property associated with their respective scopes of work, and, as allowed by existing agreements, share equally in gross profits from sales of CBD manufactured under the JDA.

“Noramco is a world-class organization with a long history of developing APIs across numerous markets and the market leader in synthetically-produced CBD. They are the obvious first choice as a partner to scale the development of our CBD biosynthesis program. Noramco’s global leadership in the production and sales of cannabinoids to pharmaceutical companies will naturally lead into manufacturing and sales into additional non-pharmaceutical markets,” says Dr. Joseph Tucker, Willow Biosciences Executive Chairman. 

Synthetic CBD over herbal?
Following hemp’s removal from the Controlled Substances Act (CSA) as part of the Farm Bill signed by President Trump in December 2018, innovation in the marijuana derivative space has flourished. However, the softening legal stance toward hemp has not been extended to CBD, derived from hemp or otherwise, as of yet. Nevertheless, this has not hampered NPD from supplements andoils to infused food and beverages and technological platforms investigating synthetic CBD. Synthetic CBD allows for the creation of CBD without the cultivation of hemp.

Novel technologies have proliferated in the space. Sustainable ingredients company Amyris Biotechnologies is en-route to commercializing fermented CBD molecules made without marijuana, for example. 

A key player in the sugar-cane fermentation market, Amyris previously launched a World Health Organization (WHO)-recommended first-line treatment for malaria – that claims to have saved thousands of lives. The company’s latest product is a zero-calorie sweetener suitable for those suffering from diabetes and obesity.

“The question we get is, can you make CBD molecules using fermentation? Can you make them so that they are highly pure, effective and have a lower manufacturing cost than traditional CBDs and come from a sustainable source? The answer to all of those is ‘yes,’” John Melo, CEO & President of Amyris, tells NutritionInsight.

He goes on to note that its process is 100 percent legal, according to US Food and Drug Administration (FDA) regulations. “We don’t rely on the hemp plant or its purification for our production of CBD molecules, which gives us a number of advantages including our ability to create highly pure CBD molecules. We use sugarcane syrup as a feedstock in our fermentation process to produce all of the molecules we make, including now, CBD molecules.”

Synthetic CBD also received a boost in its medical standing last week. A study, conducted by chemists at the University of California, Davis, US, in collaboration with researchers at the University of Reading, UK, found that a synthetic, non-intoxicating cannabidiol (CBD) alternative, 8,9-Dihydrocannabidiol (H2CBD) was found to be as effective in treating the frequency and severity of seizures in rats, pointing towards a potential therapeutic application for humans.

According to their report, the synthetic CBD alternative is easier to purify than a plant extract, eliminating the need to use agricultural land for hemp cultivation (making it cheaper), and can avoid legal implications surrounding cannabis-related products. Their work was recently published in the journal Scientific Reports.

“It’s a much safer drug than CBD, with no abuse potential and doesn’t require the cultivation of hemp,” says Mark Mascal, Professor in the UC Davis Department of Chemistry. The researchers have ambitions to conduct further studies in animals with a goal of moving into clinical trials soon. UC Davis has applied for a provisional patent on antiseizure use of H2CBD and its analogs, and Mascal has founded a company, Syncanica, to continue the development of H2CBD for commercial applications. 

However, an industry report by Rabobank elaborates that there are still ambiguities as to whether CBD has indeed proven its potential as a new consumer staple, or is slated to become another “has-been cure-all in the supplement aisle.” The analysis, which takes a hard look at the future of CBD in the US, underscores the issue of a possible crash in the hemp market due to supply chain imbalances and legal implications. With this in mind, non-farmed, fully synthetic CBD may be well-positioned to fill in gaps in this budding market. 

Edited by Laxmi Haigh