The importance of standardisation and the Therahemp model
Of late, there has been an ongoing reassessment of cannabis and the natural cannabinoids for medical purposes. The mainstream perception, which initially formed in the 1970s, that cannabis was a drug of abuse and harmful to health, was upended in November 2017 when, at the 39th ECCD Conference, the World Health Organization declared one of its main components, the non-psychotropic cannabidiol, safe to use.
Possible applications abound: from stimulating the appetite for treating weight loss in anorexia and AIDS, to the benefits observed in cancer-related treatment, like reductions in nausea and weakness, to synergistic action in the treatment of diseases of the central nervous system, like Dravet syndrome.
Market response to the rediscovery of cannabis
Clearly, the market has responded favourably to this change. Manufacturing multiplied, as did discussions on the topic, both online and off. This movement reflects a widespread, across-the-board interest in cannabis that easily and firmly takes root in the popular imagination, amplifying this trend exponentially.
However, this renewed excitement over the therapeutic properties of cannabis by stakeholders goes hand-in-hand with a lack of scientific understanding of the product and its processing methods.
While equipped with efficient methods of preparation, the businesses launched in recent years often lack a solid background and expertise in the processes involved (from cultivation to extraction and manufacturing).
The result is the marketing of products very different from one another - in terms of raw materials utilised, methods of preparing extracts, and even in percentage of cannabinoid content. These significantly different features make also it impossible to compare clinical, which are the only way to obtain a solid panel of usable data that can be compared, with the aim of creating valid treatment pathways.
This chaotic state of overproduction is met with a cautious response by the scientific community, which has recognised only a few of the many trials under way. This clearly ties back to the lack of a regulation that necessarily starts from the production process.
The importance of standardisation and GMP
If there are to be more studies in medical literature, therefore, standardised treatment options must be available. Indeed, the use of a standardised extract would make it possible to produce, through a drug clinical trial, a real, unequivocal efficacy profile of a particular extract.
To bring the situation into uniformity, we would like to see a monograph of pharmacopoeia. In the meantime, it is crucial that standardised extracts be used and that GACP and GMP be followed as the only guidelines. Specifically, the plants must come from certified grows and harvests and the entire growing process, harvest and drying must adhere to GACP (Good Agricultural and Collecting Practice), while the production process and quality control must observe GMP (Good Manufacturing Practice).
GMP is absolutely necessary in developing a drug clinical trial.
The required phases for marketing a drug call for an initial safety test (Phase I) and a subsequent efficacy analysis (Phases II and III), with assessments based on GCP (Good Clinical Practice).
Obtaining a GMP manufacturing license, which authorises production for pharmaceutical purposes, is extremely complex and there are very few companies that, have actually obtained it for Cannabis.
Why? Simply put: standardisation that follows the regulation processes for the production of drugs calls for a great deal of experience, a designed structure and various levels of competency in manufacturing, quality, analysis and research.
These measures might be excessive for non-pharmacological products, like the food supplements or cosmetics industries, (although the trend is toward the use of pharma grade products also in these areas of manufacturing) because the final quality is far superior. We advocate the use of standardised products that follow a pharmaceutical-quality process for cannabis extracts.
A standardised product guarantees the precise amount of active ingredient contained, and its expected and relative efficacy, as well as the absence of prohibited or harmful substances. Along these lines, numerous FDA recalls were announced (see, for example, JAMA study,Marcel O. Bonn-Miller et alii. JAMA 2017;318(17):1708-17099), based on reports of contaminated lots that caused serious side effects, as in the cases observed in a UC Davis Study (Thompson GR, Tuscano JM et alii. Clin Microbiol Infect. 2017; 23(4):269-270).
Ultimately, in a scenario where cannabis and cannabinoid products are relatively new but are encountering high, generalised market demand, we believe the quality of a standardised product to be crucial and necessary for the development of more coherent trials by the scientific community on the clinical applications of the cannabis extract and the cannabinoid active ingredient.
The Therahemp Experience
With the aim of widespread application of specific standardisation criteria, we would like to introduce Linnea & Crystal Hemp as excellences capable of setting new standards in this area.
Engaged for more than 35 years in the extraction of herbs and medicinal plants, Linnea systematically applies pharmaceutical standards to the production of botanical and plant-derived extracts, setting itself apart in terms of transparency and quality.
Specialised in the hemp industry, at Crystal Hemp organic cultivations strictly produced under GACP are the bedrock of the ongoing perfection of therapeutic applications of cannabinoids.
A common passion for quality and a shared vision of the need to apply scientific criteria and pharmaceutical research to the processes of plant extraction led the two companies to establish the THERAHEMP project.
Therahemp is the scientific answer to a currently chaotic state of management of the cannabis and cannabinoid market. We want to ensure standardised and safe products.
We want hemp to be therapeutic and perceived as such by the medical community and the public at large, in order that this completely natural plant fall within the array of possible medicines considered for various clinical cases.
The goal? To provide people with a totally safe and healthful therapeutic product.