The methods include growing selected cannabis plants and extracting active pharmaceutical ingredients (APIs) from their flowers in a two-step process.
Unlike traditional, multi-step methods – which can include solvents or manufacture of synthetic APIs – Axim Biotechnologies’ methods achieve an average of more than 99% purity, the company said.
“Axim’s microencapsulation method is then applied to the cannabinoids, protecting those from oxidation and degradation, while preserving its effectiveness,” it added.
CEO George Anastassov also said the methods increase the bioavailability and potential therapeutic benefits of the APIs for pharmaceutical applications.
The US-headquartered firm developed and tested the current good manufacturing practice (cGMP) methods in the Netherlands, under the country’s regulated guidelines.
“In the Netherlands, professional cultivation of cannabis is legal, therefore allowing easier access,” a spokesperson told us.
The firm plans to deliver a series of drug products in the “near future” with fewer side effects than traditional medications, and in some cases, to address unmet medical need.
“The objective is that Axim will manufacture these medicines by themselves or by contract manufacturers,” he added, explaining some of the medications may be licensed out to third parties.
GMP: ‘From seed to final product’
Anastassov told us he is not aware of any comparable cGMP methods where the entire manufacturing process – including the growth of the starting material – is carried out according to cGMP.
“As a result of this method, Axim has set the highest of quality standards for the cannabinoid industry, ensuring that the proper design, monitoring, and control of processes and facilities are in place from seed to final product,” he said.
The firm is in the process of filing for patents for these methods.
To date, Axim has two patents and three products in clinical trials including CanChew – a CBD-based controlled release chewing gum indicated to treat irritable bowel syndrome – and combination CBD/THC gum MedChew Rx, designed to treat pain and spasticity associated with multiple sclerosis.