Sixth Wave is uniquely suited to develop a commercially viable and highly competitive process for CBD and THC purification based on its IXOS® bead MIPs technology. The Company is developing the Affinity™ Extraction Process, an extraction solution specifically designed to extract THC and/or CBD from cannabis/hemp crude for the production of pure THC and CBD compounds. The technology and process will provide a robust, cost effective method to provide high purity THC and CBD for the commercial market.
The availability of pure CBD and THC allows for controlled specialty cannabis extract formulations for different medicinal indications and recreational adult uses. Pure CBD isolate, in particular, is desirable as a means of obtaining the medicinal benefits of CBD without the psychoactive effects of other cannabinoids. Studies have indicated that the majority of CBD products being marketed do not contain the amount of CBD indicated on the label and 20% contain some amount of THC.
The existing methods for Cannabinoid extraction from hemp and cannabis are only effective with small volumes of plant material and require significant CAPEX and OPEX costs. Producers must work with multi-stage processes to separate individual cannabinoid compounds.
The benefit of the Affinity™ Extraction Process is that the system has a much higher throughput of material and works within a closed-loop environment. This continuous, closed-loop system has negligible material loss which leads to higher recovery rates. More than 15% of cannabinoids can be lost through the use of traditional extraction processes.
The Affinity™ Extraction Process works within ambient conditions with no harsh solvents, uses food grade equipment and does not require highly skilled labor to operate.
Affinity™ Beads capture specific molecules by passing mixture of plant crude and ethanol though a column. The Beads capture the targeted molecules instantly and are also instantly removed (eluted) from the beads with a second ethanol cycle.
The removal of pesticides, heavy metals and other contaminants are a major industry problem as new standards are being introduced for strict removal of these nuisance materials. As the contaminants are never targeted by the Affinity™ Beads, they simply pass through the column.
Sixth Wave has completed initial development of the beads and laboratory testing using synthetic crude extracts and laboratory prepared hemp extracts, as well, actual extracts from both CO2 and ethanol primary extraction systems. Bench scale multi-column extraction testing has been completed in the laboratory and a small deployable bench test kit is under construction for testing at candidate processing partners.
The Affinity™ Pilot unit is a simple counter-current flow system in a carousel configuration utilizing up to 30 columns of Affinity™ beads. At any given time, up to 24 of those columns are configured to collect the cannabinoid from a diluted crude extract. The remaining columns are simultaneously in either a cleaning phase or extraction phase where the loaded cannabinoid is released from the bead.
The first pilot plant has been installed and is being commissioned at a major CBD processor.
Aristotle Kalivretenos, Ph.D.
Chief Technology Officer
Aristotle Kalivretenos, Ph.D. leads the Research & Development team for Sixth Wave. Aris is responsible for new product development and commercialization of Molecularly Imprinted Polymers (MIPs) for Life Science Applications, including pharmaceuticals, natural products, food safety, healthcare and drug detection. Aris performed a post-doctoral fellowship focusing in the CNS area at Columbia University after earning his PhD in organic chemistry from Colorado State University and a BS in chemistry from Clemson University.
Affinity™ Production Unit
The first Affinity™ Production units are scheduled to be delivered in Q4 2019.
These units will have the following key advantages:
- GMP compliant (US, Canada, EU)
- Unlimited Scalability
- Significantly Faster and more efficient than Chromatography (Shorter Processing time and Negligible Product loss)
- Significantly lower CAPEX/OPEX
- Suitable for production of high purity Cannabinoid Distillates & Isolates
Several methods currently utilized for the extraction of CBD and THC from cannabis extracts, including chromatography, extraction with organic solvents (e.g. pentane) and sub-and supercritical CO2 extraction. A newer technology based on membrane extraction has been reported by Green Sky Laboratories (Green Sky Labs, Poster Presentation, March 2018).
In general, primary extraction processes which releases the cannabinoids from the plant matter use organic solvents (e.g. propane, butane, ethanol) and sub- and supercritical CO2, depending on the technique used the result is a mixture of cannabinoids and can also contain terpenes, lipids, waxes, flavonoids, and plant material including chlorophyll. While there are some recreational uses for these crude extracts, the vast majority of the existing and anticipated market is in high quality distillares and isolates. These products require post-extraction processing. This process usually starts with sequential distillation of the crude which removes a lot of the unwanted material but leaves the cannabinoid spectrum relatively untouched.
The only process widely used to generate either high purity THC and CBD (or other cannabinoids) from the plant extracts is chromatography. It is typically used as a final processing step with pre-processed material (to remove all components except cannabinoids) as the starting material, adding cost to the final pure products. Although the chromatography process is currently employed for cannabis extract purification, it suffers from various shortcomings which limit commercial viability at the levels needed to meet emerging market demand.
Chromatography is a labor-intensive process which can also suffer from incomplete purification (retention of residual impurities/undesired side-products). While larger variations of chromatography equipment is around, the overall process is not cost effective and is limited in scalability without incurring great expense. Chromatography also requires relatively pure cannabinoid material (e.g. terpenes and waxes removed) to improve efficiency and limit fouling of chromatography media (e.g. silica gel). Depending on the solvent system used, there are also cost concerns and safety concerns as some of the solvents needed for chromatography are toxic.
By contrast, Affinity™ can be used with crude extracts that are treated only to remove the heavy lipids and can be scaled to process at any throughput. Dilution of crude is done with water and ethanol and removal of the target cannabinoids from the Affinity™ nanotechnology is also done with mixtures of water and ethanol.
Sixth Wave has deployed a rapidly reconfigurable pilot Affinity™ Alpha plant at a major US hemp processor. The system is being used to complete performance optimization of the Affinity™ system and develop Standard Operating Procedures (SOPs) for generating isolates and THC free full spectrum distillates. The Company is already engaging contract manufacturers to produce the Affinity Alpha line of purification systems with the goal of having manufacturing in North America and the EU. The Alpha systems will be built to meet the rigors of US, Canada, and EU Good Manufacturing Practices (GMP) certification allowing any cannabis processor using the Affinity™ Alpha systems to obtain such certifications for their facility.
Additionally, the Company has already begun transitioning manufacturing of the Affinity™ nanotechnology beads to its bulk manufacturer. The beads will be produced using all Generally Regarded as Safe (GRAS) chemicals and our manufacturing plant/process is already certified GMP. The scale up will result in the beads being manufactured in a 1,000-gallon reactor which will give the Company the ability to create over 1000kg of beads weekly. Sixth Wave is currently reviewing all regulatory considerations and possible registrations that may be required or voluntarily submitted to enhance the product’s adoption worldwide.
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