Dr Toby Astill, global market manager - Cannabis and Hemp Markets at PerkinElmer, talks about the growth of cannabis in the pharmaceutical industry and the importance of chromatography to this sector.
Chromatography has an essential role in the future of cannabis for pharmaceutical uses in countries where it is allowed. It is already the most popular analytical technique used to maintain strict quality control throughout the cannabis’ life cycle - from the plant in the ground to the eventual medical product. This is because chromatography can effectively measure the potency and percentage of tetrahydrocannabinol (THC), the psychoactive compound in cannabis.
As more European countries explore the pharmaceutical applications of cannabis, we expect to see increased interest in the infrastructure required for making sure that products are safe, good-quality and able to uphold regulatory standards.
The growth of cannabis-based products in Europe and beyond: CBD and THC
In the last few years, the global health and wellness sector has explored what it can offer users through the benefits of cannabidiol (CBD). Cannabis’s two main compounds are the THC, which produces a psychoactive effect, and CBD, which does not. CBD has become so mainstream in certain countries that London’s prestigious department store Liberty has a whole area dedicated to consumer applications of this hemp-derived product.
In Europe, a number of countries have legalised the production, distribution and sale of CBD and set a THC threshold to ensure the products do not carry the psychoactive effects associated with cannabis. Typically, if the THC levels are 0.3% or below, it is classified as CBD; any higher, it is legally considered to be cannabis. However, this level is not standardised - and it can lead to problems. In Germany and the UK, the legal threshold for CBD is 0.2%, whereas in Switzerland it is 1%. This means commerce can be difficult as CBD products cannot always be shipped from one country to another due to the diverging limits and legalities.
Beyond the lifestyle boom of CBD products, there has been a huge movement to conduct studies to support pharmaceutical uses of cannabis. Cannabis is not well-studied compared to other drugs, and European countries (along with Israel) are regarded as trailblazers when it comes to researching its medicinal benefits.
British company GW Pharmaceuticals launched the first Food and Drug Association (FDA) approved cannabinoid drug for child epilepsy in 2018 in the US, which was fast-tracked to be used medically in the UK by the NHS in 2019. To make this happen, it had to have the appropriate health studies and undergo rigorous testing required for any pharmaceutical product. The launch was a huge success - and the product has grown domestically in the UK and has also been distributed globally.
GW Pharmaceuticals’ work had a seismic impact on the industry. Countries are looking at Europe to understand how to legalise and regulate this market - including the USA, Colombia, Uruguay, Thailand and others. There may soon be a shift where countries and companies alike weigh up the medical benefits of cannabis and consider whether it could or should be legalised for pharmaceutical purposes. One thing is certain: stringent processes must be in place to support this legal growth, and testing to support pharmaceutical collaborations is of utmost importance.
The importance of chromatography
In simplest terms, cannabis is a weed, and every plant under the sun is slightly different. It presents an operational challenge for companies growing cannabis and maintaining a consistent medical level in their products. Testing throughout the manufacturing supply chain is vital for pharmaceutical companies to ensure the cannabis fits quality control standards.
There are several techniques that can be used to quantify cannabis but chromatography is by far the most common. Chromatography separates substances according to their chemical characteristics so they can be easily identified. In the case of cannabis, high-resolution liquid chromatography (HPLC) enables the characterisation and quantification of active molecules such as THC and CBD contained in a plant sample. For example, with the PerkinElmer LC300 HPLC, it is possible to separate up to 16 component cannabinoids in less than six minutes. When HPLC is coupled with tandem mass spectrometry in addition to potency testing, it is possible to ensure the absence of contaminants such as pesticides and mycotoxins down to low parts per billion (ppb).
Pharmaceutical laboratories can take advantage of chromatography and mass spectrometry platforms to accurately report plant potency and terpene profiles, but also determine possible contaminants such as pesticides, mycotoxins and heavy metals.
This chemical process is essential for legal reasons: depending on the country (as referenced above), any product with over a certain percentage of THC must be treated as cannabis rather than CBD. It’s also critical for medical and pharmaceutical purposes: for efficacy, products need a certain percentage to effectively treat a patient. Chromatography can be used across the life cycle of the cannabis plant, from research and development to studies and as an excellent tool to ensure the manufactured product is of the same robust quality.
We expect the pharmaceutical industry will want to understand the full spectrum of cannabinoids. In Israel, for example, laboratories are exploring the interactions of over 100 cannabinoids with the human body. This is an area that is only just starting to be investigated.
The future of pharmaceutical cannabis - what’s next?
Right now, the future looks incredibly bright for Europe’s cannabis industry, which is set to reach over €3 billion by 2025. More European countries are set to introduce legal access to medical cannabis within the next few years, such as Switzerland. This is significant because legal opportunities lay the grounds for a potential market. At the same time, serious investments are being made to ensure the pharmaceutical cannabis is scrutinised, robust and safe. All new industries are regarded with some suspicion, but cannabis’ history means it is more essential than ever to be scrupulous.
Life sciences companies have had access to scheduled materials and been able to study, research and develop cannabis and cannabinoids for decades. They approached the testing of cannabis initially from a toxicology perspective and are now able to easily adapt to support from a pharmaceutical testing point of view. This detailed and nuanced background means chromatography is informed by experience - knowing how challenging yet essential testing can be. A decade ago, PerkinElmer worked with few dedicated cannabis labs across global locations to understand the fundamental methodologies and instrument workflows needed to characterize the plants composition successfully - it now supports over 100 labs globally and expects this to grow in accordance with the industry.
As a marker of international validation of the medical cannabinoid sector, GW Pharmaceuticals sold for $7.2billion in 2021 - a record-breaking deal. More and more countries and companies are starting to take notice of cannabis and its growth trajectory - and we will continue to support this exciting space. The world is watching to see how Europe and Israel continue to innovate.