AXIM Biotechnologies (AXIM) announced today that it has successfully executed current good manufacturing practices (CGMP) methods to extract and microencapsulate cannabinoid molecules. AXIM claims it is the first company in the world to successfully perform the procedure; allowing the company to provide Active Pharmaceutical Ingredients (APIs) of unparalleled purity in various pharmaceutical delivery formats.
CGMPs are the United States Food & Drug Administrations main regulatory standard for ensuring pharmaceutical quality for human pharmaceuticals. Although several companies are currently in the process of developing cannabis-based pharmaceuticals, including GW Pharmaceuticals (GWPH) with its flagship product Epidiolex, none so far have been able to successfully manufacture a product that is CGMP compliant.
CGMP regulations include establishing strong quality management systems, comprehensive operating procedures, the ability to detect and investigate product quality deviations, as well as maintaining reliable laboratory testing conditions.
As the only company currently capable of producing CGMP compliant APIs, AXIM stands to profit greatly from the head start. According to a report by Ackrell Capital, the legal cannabis market is expected to grow to over $100 billion by 2029, half of which will come from cannabinoid-based pharmaceuticals.
The company’s proprietary process was developed in the Netherlands in accordance with regulatory guidelines, beginning with the initial growth of the cannabis plant. APIs are extracted from the cannabis plant using a two-step, solvent-free, extraction process.
The cannabinoids are then protected from oxidation and degradation using a microencapsulation process, allowing them to be manufactured into pharmaceutical-grade cannabis products. In addition, the company believes that the new extraction process can also be used to take unusable cannabis flow, such as those tainted by pesticides, and turn it into containment free cannabis oil.
“We’re thrilled to be able to announce this new method to the industry,” said George E. Anastassov, CEO of AXIM Biotech, in a statement. “Our innovative extraction process achieves reliable and effective results while providing a high purity level. By microencapsulating these molecules, we are able to protect them and preserve the APIs while increasing their bioavailability and the potential therapeutic benefits for a variety of pharmaceutical applications.”