Tag Archives: nanotechnology

Cannabis Compliance Testing: Safety vs. Quality

By Vanessa Clarke, Melody Lin
1 Comment

Dr. Markus Roggen is a chemist, professor, cannabis researcher and founder & CEO of Complex Biotech Discovery Ventures (CBDV). Founder & CEO of Ascension Sciences (ASI), Tomas Skrinskas has been at the leading edge of transformative healthcare technologies, including computer assisted surgery, surgical robotics and genetic nanomedicines, for over 15 years.

Leading researchers from the cannabis industry – Dr. Markus Roggen (Complex Biotech Discovery Ventures) and Tomas Skrinskas (Ascension Sciences) – highlight the challenges facing the industry’s current compliance testing standards and the opportunities emerging from the latest developments in nanotechnology and advanced analytical testing. Here are the key insights from the discussion. 

What are the current compliance testing requirements for cannabis products? Are they sufficient in ensuring safety and quality?

In the current landscape, Canada’s compliance testing requirements are clearly laid out in the form of guidance documents. Specifically, for pesticide testing, cannabinoid concentration content in products, heavy metals, etc. Compliance testing can be roughly divided into two categories: 1) establishing the concentrations of wanted compounds, and 2) ensuring that unwanted compounds do not exceed safety limits.

In the first category, cannabinoids and terpenes are quantified. Their presence or absence is not generally forbidden but must stay within limits. For example, for material to be classified as hemp, the THC concentration cannot exceed 0.3 %wt., or a serving of cannabis edible should contain below 5 mg of THC. The second category of compliance testing focuses on pesticides, mold and heavy metals. The regulators have provided a list of substances to test for and set limits on those.

Are those rules sufficient to ensure safety and quality? Safety can only be ensured if all dangerous compounds are known and tested for. Take for example Vitamin E acetate, the substance linked to lung damage in some THC vape consumers and the EVALI outbreak. Prior to the caseload in the Fall of 2019, there were no requirements to test for it. It’s not only additives that are of concern. THC distillates often show THC concentrations of 90% plus 5% other cannabinoids. What are the last 5% of this mixture? Currently, those substances have not been identified. Are they safe? There is no concrete way to determine that.

The aforementioned guidelines have the best intentions, but do not adequately address two key obstacles the industry is currently facing: 1) what happens in practice, and 2) what can easily be audited? Making sure people follow the requirements is the challenge, and it comes down to variability of the tests. Testing has to happen on the final form of the product as well as every “batch,” but there is little guidance on how that is defined. With so much growth happening in the industry, how are these records even tracked and scrutinized?

And finally, there’s the question of quality. How do you define quality? Before establishing quantifiable quality attributes, it can’t be tested.

If compliance testing is insufficient, then why aren’t more cannabis companies testing beyond Health Canada’s requirements?

Compliance testing has always been focused on the end product, THC and CBD levels, and consumer safety. As long as cannabis companies are testing to determine this, doing further testing means added costs to the producer. There is a rush to get cannabis products to the new market because many consumers are eager to buy adult use products such as extracts or edibles, and quality is not the biggest selling point at this very moment.

However, there are unrealized advantages to advanced analytical testing that go beyond Health Canada’s requirements and that offer greater benefits to cannabis producers and product developers. Producers often see testing as an added cost to their production that is forced upon them by the regulators and will only test once the product is near completion. For cannabinoid therapeutics and nutraceuticals, advanced analytical testing is critical for determining the chemical makeup and overall quality of the formulation. This is where contract researchers, such as Ascension Sciences, come in to offer tests for nanoparticle characterization, cannabinoid concentration, dissolution profiles and encapsulation efficiency.

HPLC (high pressure liquid chromatography) instrument.

A lack of budget and awareness have prevented cannabis companies from advanced analytical testing. However, testing that goes beyond lawful requirements is an opportunity to save money and resources in the long term. This is where companies, like Complex Biotech Discovery Ventures (CBDV), offer in-process testing that provides a deep characterization and analysis of cannabis samples during every stage of product development. If tests are conducted during production, inefficiencies in the process are revealed and mistakes are spotted early on. For example, testing the spent cannabis plant material after extraction can verify if the extraction actually went through to completion. In another case, testing vape oil before it goes into the vape cartridges and packaging allows producers to detect an unacceptable THC concentration before they incur additional production costs.

Which methods are the most successful for cannabis testing?

The most effective method is the one that best determines the specific data needed to meet the desired product goal. For example, NMR Spectroscopy is paramount in assessing the quality of a cannabis sample and identifying its precise chemical composition.

HPLC (liquid/gas chromatography) is the most precise method for quantifying THC, CBD and other known cannabinoids. However, if a cannabis extractor wants to quickly verify that their oil has fully decarboxylated, then an HPLC test will likely take too long and be too expensive. In this case, IR (Infrared Spectroscopy) offers a faster and more cost-effective means of obtaining the needed data. Therefore, it ultimately depends on the needs of the producer and how well the testing instruments are maintained and operated.

What’s next in analytical testing technology? What are you working on or excited about?

In terms of compliance, regulations to standardize the testing is the hot topic at the moment. For nanotechnology and nanoparticles, the big question now is what is known as the “matrix” of the sample. In other words, what are the cannabinoids, and what else is in the sample that’s changing your results? The R&D team at Ascension Sciences is in the process of developing a standardized method for this to combat the issues mentioned earlier in the interview.

The smoke analyzer in CBDV’s lab

Ascension Sciences is also excited about characterizing nanoparticles over time to determine how cannabinoids are released and how that data can be transferred or made equivalent to consumer experiences. For example, if a formulation with quicker release, faster onset and better bioavailability is found in the lab, product development would be more efficient and effective when compared to other, more anecdotal methods.

At CBDV, the team is working on in-process analytical tools, such as decarboxylation monitoring via IR Spectroscopy and NMR Spectroscopy. CBDV is also looking at quantifying cannabis product quality. The first project currently in motion is to identify and quantify cannabinoids, terpenes, and other compounds present when vaping or smoking a joint using a smoke analyzer. 

A lack of budget and awareness have prevented cannabis companies from testing beyond what’s required by Health Canada. Compliance testing is designed to ensure safety, and for good reason, but it is currently insufficient at determining the quality, consistency and process improvements. As the above factors are necessary for the advancement of cannabis products, this is where further methods, such as advanced analytical testing, should be considered.

This Bud’s For You: Tilray Enters The Drinkable Cannabis Market

By Marguerite Arnold
1 Comment

The race is on for drinkable cannabinoids. In mid-December, Tilray announced a $100 million joint venture with Anheuser Busch to research and develop infused non-alcoholic drinks for the Canadian market.

This is the second big beer company to partner with a cannabis industry leader (see Canopy Growth’s partnership with Constellation Brands), who has just invested another $4 billion in the company.

Molson Coors also announced a deal with Hexo in August. On the non-alcoholic side of the ledger, Coca-Cola and Aurora have also had talks, reportedly eyeing the cannabis market.

Short term in other words, a lot of drinkable cannabis is coming to a market near you.tilray-logo

Why Is Drinkable Cannabis So Intriguing?

Cannabinoids themselves, are not water soluble. However, when cannabinoids are subjected to a process called nano emulsion, (emulsified oil, water and molecules), they can be not only added to drinks but potentially represent one of the most cutting edge forms of drug, vitamin, mineral and overall nutrition delivery. Nanoemulsions are approximately the size of viruses, proteins and antibodies with a transparent or semi-translucent appearance. They also tend to increase bioavailability of substances.

In other words, while the focus on the market as it is developing in Canada is “recreational” and “beverage” use, in fact, this technology can be applied to food. It will also be used, obviously on the medical side of the equation too.

Nanotechnology overall is actually a manufacturing technology that works with atoms to change the structure of matter. When it comes to edibles of all kinds (food, drinks and medications) nutrients are absorbed more uniformly and pass through to membranes directly into human cells.

The impact of that technology, mixed with a revolutionary drug, is no longer theoretical.One of the best known uses of nanotechnology in the world is also one of the most common condiments. Mayonnaise for example, is an emulsion of tiny particles where oil and water are mixed together without separating. That said, these days researchers are developing techniques that allow these tiny droplets to be precisely tailored to give them specific tastes and textures.

The technology, in other words, that the cannabis and major drinks manufacturers are now developing, will allow cannabinoids to be used in food, drinks and medications in ways that go far beyond pills and oils.

This is not your grandparent’s beverage, food, drug or alcohol market in other words. This represents another way for the cannabis industry to lead the way on a range of products far from “canna-beer.” Or even THC-infused social lubricants.

The impact of that technology, mixed with a revolutionary drug, is no longer theoretical.

The Cellular Revolution of Cannabinoids Is Now Here

If allowed to efficiently access cells via nanotechnology, no matter how it is consumed, the idea of a cannabis infused food or drink might well become enough not only to “keep the doctor away” but in general revolutionize concepts of nutrition, not to mention medication.

That said, there are still many questions in general that remain about the safety of this kind of technology within the human body. Nanoceuticals can help bypass typical protective barriers of the body and deliver bio-chemicals that the body would not normally encounter. There has not been a lot of study (yet) on their biodegradability or metabolism of nanotechnologies. Namely the human body may not be able to expel them. They are currently unregulated and can be introduced to the market with little or no evidence of safety or efficacy although this is also on the way. There are concerns that this delivery method could literally disrupt DNA.

Cannabinoids themselves appear to be a systemic biological regulator. But the active ingredients used to emulsify the plant may or may not be.

In an industry in other words, which has systematically been ahead of regulatory approval, starting with legalization itself, the future looks not only highly intriguing, but full of major debates about with what and how human beings are nourished, and treated medically.

As usual, in other words, the cannabis industry, is pioneering a truly brave new world.