Many clinical studies on medical cannabis products have been conducted in numerous countries around the world including Israel.
Researchers have been trying to explain the mechanisms of action and efficacy of cannabis plant compounds and their active ingredients. Today, various cannabis strains and products, medical and recreational, are being used in countries all over the world, for the treatment of serious diseases, such as neuropathic pain, PTSD, epilepsy, aids, MS, cancer, and many others.
The cannabis flowers, which patients commonly use via smoking or vaping under a prescription, do not contain consistent concentrations or compositions of active ingredients such as cannabinoids and terpenes, whether they are from the same cannabis strain, or harvested from the same plant and at the same time. In order to decrease the variance between cannabis plants from the same strain and from the same plant, we have to follow controlled and repeatable cultivation techniques, enhancements, and use a multitude of different species. At the end of the process, our main target is to cultivate cannabis plants with similar active ingredients composition and concentration, in a repeatable manner over a relatively long period of time. In addition, in our growing and products manufacturing methods and procedures, we will meet GAP (Good Agriculture Practice) and GMP (Good Manufacturing Practice) requirements and standards in order to supply a safe and effective pharma-grade drug product that will meet all quality standards such as strength, purity, and identity.
Medical cannabis products development and approval as a medical treatment
Over the past two decades, more and more medical cannabis research and clinical trials are being conducted on various medical conditions. These include palliative treatments for relieving symptoms of serious illness such as cancer, HIV and others. Often, cannabis products are found to be more safe and efficient compared to conventional prescription drugs such as opiates for pain relief. Many studies are being conducted in various countries including Israel, trying to find the cannabis mechanism of action on different health conditions and diseases and to find the relevant active ingredients and the best delivery system for that condition. Impressive scientific results were reported in both In-Vitro models of tissue culture cells and In-vivo models of animals, as well as in clinical trials on humans.
At the same time, given the fact that the cannabis plant has been used in many countries, mostly as a palliative medicine for patients with serious illness, quite a lot of data collected over the years, has been analyzed and used to prove the safety and efficacy of cannabis-based medicines in accordance with the regulatory requirements of the ministry of health. One example is Nabiximol, a cannabis plant extract combining THC and CBD which is administered as a spray into the mouth.
So far, more than 520 materials in the cannabis plant have been identified. Not all of them are cannabinoids, there are also terpenes and flavonoids which apparently have a therapeutic effect, whether alone or as a combination of substances originating from cannabis plants. Today, most cannabis companies, as well as the Israeli Health Ministry, relate to only two main active ingredients in the cannabis plant; THC, known as the psychoactive substance, which also offers therapeutic qualities. And CBD, known as therapeutic, psychoactive-effect free. In the market, there are a lot of cannabis products that contain only CBD and are mostly used for treating children with Epilepsy.
Several clinical trials which focused on specific active cannabinoids did not show good results compared to treatments with remedy or inflorescences of the natural whole plant, which is characterized by the large and varied composition of materials with therapeutic effects and synergism.
Why Cannabis cannot yet be considered as an ‘approved medicine?’
Despite all the positive feedback received from doctors treating patients using cannabis as well as feedback received from patients using cannabis and their families, the cannabis plant is included in the dangerous drugs list.
Medical cannabis products, in countries where medical cannabis can be prescribed for specific indications, do not contain the same concentration and composition of the active ingredients, whether they are the same cannabis strain, the same greenhouse, or harvested from the same plant and at the same time. In order to effectively treat a disease in a repeatable manner, we have to find a way to use the “right” genetics and to use the best growing techniques and good practices to control the parameters which may impact the final product’s consistency and quality.
In order to develop an approved drug product that will meet all regulatory requirements, we need to investigate and prove the model of activity of the experimental drug and how it affects biochemical and physiological mechanisms in the body. Therefore, experimental drugs should be identical and with the same dose levels. In addition, in accordance with GMP principles, each drug should meet defined criteria of identity, strength, purity and be safe to use.
The lack of uniformity of medical cannabis inflorescences from the same species
There are two main species of cannabis: Sativa and indica. Today, 99% of the species are not pure, as a result of hybridization and natural selection that has occurred over the years.
Although knowledge has accumulated in growing cannabis over the years, as well as the existence of high THC strains, very few strains are found to be stable in the long run. Not enough effort and progress has been made regarding the developing of cannabis strains for medical use. Also in cannabis plants from stable, high-quality strains, the concentration ranges of active ingredients such as THC and CBD are too wide and indicate a relatively high variance and thus are unable to treat patients effectively. In the majority of cases, what the patient receives today is not necessarily what he is going to have tomorrow, therefore, various health authorities around the world won’t allow using cannabis as medicine so easily, but only as a palliative option.
Developing and using multitude and crop techniques, along with applications and implementation of advanced quality methodologies, while increasing control levels over the various growth stages, all together, will reduce variance between products from the same plant strain or the same mother plant.
Cannabis multitude techniques to produce uniform medicine
In order to decrease the variance between cannabis plants of the same strain or between different flowers from the same plant, consistent growing and cultivation procedures must be implemented and followed which meet the GAP and GMP standards for usage as high-quality GMP grade API (active pharmaceutical ingredient) for cannabis medicinal products.
Today, even plants genetically identical, using twigs taken from the mother plant will be altered over time. Within a few generations, there will be variance which makes it difficult to supply the consistent medical cannabis product.
Cannabis plants growth control for medical purposes
How can we improve the cannabis plant as a raw material for GMP medicine manufacturing?
Apparently, any disease or medical condition has a cannabis strain which is more appropriate for treatment and vice versa. Therefore the “right genetics” of the cannabis plants must be chosen carefully in order to treat a specific disease. In recent years, as part of clinical trials on humans, cases of treating a patient with a particular cannabis strain species was found to be very effective, however, treatment with other strains with the same content, showed less efficacy which caused the researchers a lot of frustration. Further studies should be performed focusing on the hybridization of cannabis strains found to be effective to improve the desired active materials concentration and composition and as a result, to enhance the efficacy of the cannabis medicine for the treatment of a certain medical condition.
Cannabis plants self-pollination or cannabis in-breed lines for medicinal purposes
Future cannabis growing research should be focused on Cannabis inbreed lines or self-pollination of cannabis plants, which may theoretically lead the industry towards better preservation for cannabis plant’s genotype and phenotype over time.
It may be possible to encourage the mother plant to produce stamen, which will be used to fertilize other mother plants, in order to receive female cannabis seeds which resemble their original plant genetics.
Appropriate stamen storing, allows for long-term use, stamens can be preserved for long periods of time even longer than seeds, and as a result, will enable the continuous supply of uniform and consistent cannabis plants for pharmaceutical and medical purposes.
About Cannabis GxP consultancy
Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.
Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.
We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.
Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, Quality Assurance, Good Practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.
Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the Pharmaceutical field, medical devices, Cosmetics and food supplements industry based in Israel.
Our cannabis consultancy services include:
For more information and consultancy in choosing the Cannabis Cultivation process best suited to your company’s needs, please do not hesitate to contact us.