We’ve covered the CannaGrow Expo previously, but this time around we catch up with Joseph De Palma, founder of CannaGrow, to talk about the genesis of his conference and what makes the event so special. This year’s CannaGrow Expo heads to Palm Springs, California, a new location for the event, on May 19thand 20th.
We’ve watched De Palma’s conference grow over the years, moving around the country and becoming the tight-knit community we know it as today. The meat and potatoes of the show are definitely the educational sessions, panel discussions, roundtables and the expo hall. But covering it year after year we’ve noticed a real sense of community develop, one where genuine idea sharing, collaboration and inclusivity are preached. There are no dumb questions at the CannaGrow Expo.
According to Joseph De Palma, CannaGrow started in 2014, when the original event was held in Denver. “From the beginning, we wanted to create an event specifically for growers, where the focus was always on education and ‘becoming a better grower’,” says De Palma. “We had experienced the existing events in the marketplace, and almost all fit into two categories at the time, festival, or generic tradeshow. Those were fine for their purpose, but they didn’t foster an environment of education, and that’s what we believed was most important to the emerging cannabis industry.” Back in 2014, their show only had 10 sessions and 30 exhibitors. “Passionate growers from around the country had 2 days of grow-focused sharing and learning, and you could see the energy and excitement,” De Palma says. “Discussions would dive deep, people made new friends, and it really elevated the conversation around cultivation.”
Since the show’s debut, it’s grown substantially. The 7th CannaGrow Expo is fast approaching, and this upcoming conference has four separate tracks and roughly 100 exhibitors. But it still keeps its sense of community, one where you don’t feel crowded, where everyone has time to chat and network, without the overwhelming feeling that can come with larger trade shows. “That inclusivity and open dialog is built in,” says De Palma. “If you go to an event that’s tradeshow dominant, most people are there to walk, shop, and leave. At CannaGrow, growers and extractors come together with a plan for the weekend, remaining in a constant state of engagement with others at the show.”
This year’s show has some exciting additions to look out for. The agenda covers a wide range of topics, including everything from an introduction to growing with living soil to a discussion of cyber security. The Extraction Summit, new to this year’s event and held on Day 2, is their response to the massive rise in popularity and demand of extracts.
Eric Schlissel, cybersecurity specialist, president and chief executive officer of GeekTek, is giving a talk focused on IT infrastructure. “My presentation will center around the actions cannabis businesses need to take right now to repel cybercrime and potential federal seizure,” says Schlissel. “As cannabis operators build their businesses and develop their security strategies, they often focus exclusively on the physical portion of their business – the merchandise and the cash in particular – and overlook the importance of designing and fortifying a secure IT infrastructure. I will discuss the importance of a holistic security strategy that embraces both and how you can both create one and prepare it for expansion into other states or even globally from the very start.” Schlissel’s discussion is one example of just how all-encompassing CannaGrow intends to be.
De Palma and his team leave few stones unturned as the show truly delivers vital information for cannabis cultivators in every area. Some things we are looking forward to? Seeing old friends and learning everything under the sun about cannabis science, growing and extraction. “People get to know each other, and with everyone sharing a core passion for cultivation and extraction, lifelong friendships are made,” says De Palma.
Automation of processes can provide great benefits including improved quality, improved throughput, more consistency, more available production data, notifications of significant events and reduced costs. However, automation can also be expensive, overwhelm your workforce, cause future integration problems and magnify issues that you are currently experiencing. After all, if a machine can do work 100 times faster than a human, it can also produce problems 100 times faster than a human. Whether it is a benefit or a scourge depends largely on the implementation process.
There are thousands of possible technology solutions for just about any production problem. The trick to getting results that will work for your company is to use good engineering practices starting from the beginning. Good engineering practices are documented in various publications including ISPE Baseline Guides, but there are common threads among all such guides. What will the system be used for and what problem is it intended to solve?
The key is implementing a system that is fit for your intended use. As obvious as it sounds, this is often the most overlooked challenge of the process. In the grand scheme of things, it is a MUCH better proposition to spend more time planning and have a smooth operation than implement a system quickly and fight it because it isn’t a good fit for the intended use. The industry is littered with systems that were prematurely implemented and complicate rather than simplify operations. Planning is cheap, but fixing is expensive.
The most important step to getting an automated system that will work for you is also the first:
Defining “what” you need the system to do: User Requirements
With decades of experience in the automation industry, I have seen systems in many industries and applications and it is universally true that the definition of requirements is key to the success of the automation adventure. To clarify, the user requirements are intended to define “what” the system is required to do, rather than “how” it will do it. This means that persons that may not be familiar with the automation technologies can still be (and usually are) among the most important contributors to the user requirements document. Often, the people most familiar with the task that you wish to automate can contribute the most to the User Requirements document.
Some of the components of a User Requirements document typically include:
Purpose: What will the system be used for and what problem is it intended to solve?
Users: Who will be the users of the system and what is their relevant experience?
Integration: Is the system required to integrate into any existing or anticipated systems?
Regulatory Requirements: Is the system required to meet any regulatory requirements?
Functions: What is the system required to do? This may include operating ranges, operator interface information, records generation and storage, security, etc.
Performance: How many units per hour are required to process? What percent non-conforming product is acceptable?
Environment: What environment is the system required to operate in? Indoor, outdoor, flammable, etc.
Documentation: What documentation is required with the system to support ongoing maintenance, calibration, etc.?
Warranties/Support: Will you perform work in-house, or will the manufacturer support the system?
The level of detail in the User Requirements should be scaled to the intended use. More critical operations may require more detailed and formal User Requirements. At a minimum, the User Requirements could be a punch list of items, but a detailed User Requirements may fill binders. The important thing is that you have one, and that the stakeholders in the operation have been involved in its production and approval.Once completed, the User Requirements can be a very good document to have for prospective providers of solutions to focus their attention on what is important to you, the customer.
Equally important to the process is the idea of not over-constraining the potential solutions by including “how” the system will meet the requirements within the User Requirements. If it is required to use specific technologies for integration with other existing systems, it is appropriate to include that information in the User Requirements. However, if use of a particular technology (e.g. “wireless”) is not required, the inclusion may unnecessarily eliminate viable design options for systems that may address the requirements.
Once completed, the User Requirements can be a very good document to have for prospective providers of solutions to focus their attention on what is important to you, the customer. This helps to ensure that they focus their efforts in the areas that match your needs and they don’t waste resources (which translate to your costs) in areas that don’t have tangible benefits to you, the customer. It also gives you a great tool to “value engineer”, meaning that you can consider cutting design options that do not support the User Requirements, which can reduce project costs and timelines, keeping things lean and on track.
Further steps in the project are built around the User Requirements including system specifications provided by vendors, testing documentation and the overall turnover package. An appropriately scaled User Requirements document is a low cost, easy way to ensure that your automated system will serve you well for years to come. Alternatively, the lack of a User Requirements document is an all-too-common indicator that there may be challenges ahead including scope creep, missed deadlines and unacceptable long term performance.
Parts One and Two in this series have defined Good Manufacturing Practices, introduced Hazard Analysis and Critical Control Points (HACCP) and explained the first HACCP step of hazard analysis. A food safety team will typically work from a flow diagram to identify biological, chemical or physical hazards at each step of processing and packaging. Once the hazard is identified, the severity and probability are debated. Hazards with severe consequences or high probability are carried through the HACCP plan as Critical Control Points (CCPs).
Critical Control Points definedHACCP is a do-it-yourself project.
Where exactly will the hazard be controlled? CCPs are embedded within certain steps in processing and packaging where the parameters, like temperature, must be met to ensure food safety. Failure at a CCP is called a deviation from the HACCP plan. The food safety team identifies where manufacturing problems could occur that would result in a product that could cause illness or injury. Not every step is a CCP! For example, I worked with a client that had several locations for filters of a liquid stream. The filters removed food particles, suspended particulates and potentially metal. We went through a virtual exercise of removing each filter one-by-one and talking through the result on controlling the potential hazard of metal. We agreed that failure of the final filter was the CCP for catching metal, but not the other filters. It was not necessary to label each filter as a CCP, because every CCP requires monitoring and verification.
Identification of a CCP starts more documentation, documentation, documentation.
Do you wish you had more reports to write, more forms to fill out, more data to review? No. Nobody wants more work. When a CCP is identified, there is more work to do. This just makes sense. If a CCP is controlling a hazard, you want to know that the control is working. Before I launch into monitoring, I digress to validation.
CCP validationThis is where someone says, “We have always done it this way, and we have never had a problem.”
You want to know if a critical step will actually control a hazard. Will the mesh of a filter trap metal? Will the baking temperature kill pathogens? Will the level of acid stop the growth of pathogens? The US had a major peanut butter recall by Peanut Corporation of America. There were 714 Salmonella cases (individuals) across 46 states from consumption of the contaminated peanut butter. Imagine raw peanuts going into a roaster, coming out as roasted peanuts and being ground into butter. Despite the quality parameters of the peanut butter being acceptable for color and flavor, the roasting process was not validated, and Salmonella survived. Baking of pies, pasteurization of juice and canning all rely on validated cook processes for time and temperature. Validation is the scientific, technical information proving the CCP will control the hazard. Without validation, your final product may be hazardous, just like the peanut butter. This is where someone says, “We have always done it this way, and we have never had a problem.” Maybe, but you still must prove safety with validation.
The hazard analysis drives your decisions.
Starting with the identification of a hazard that requires a CCP, a company will focus on the control of the hazard. A CCP may have one or more than one parameter for control. Parameters include time, temperature, belt speed, air flow, bed depth, product flow, concentration and pH. That was not an exhaustive list, and your company may have other critical parameters. HACCP is a do-it-yourself project. Every facility is unique to its employees, equipment, ingredients and final product. The food safety team must digest all the variables related to food safety and write a HACCP plan that will control all the hazards and make a safe product.
Meeting critical limits at CCPs ensures food safety
The HACCP plan details the parameters and values required for food safety at each CCP.The HACCP plan identifies the minimum or maximum value for each parameter required for food safety. A value is just a number. Imagine a dreadful day; there are problems in production. Maybe equipment stalls and product sits. Maybe the electricity flickers and oven temperature drops. Maybe a culture in fermentation isn’t active. Poop happens. What are the values that are absolutely required for the product to be safe? They are often called critical limits. This is the difference between destroying product and selling product. The HACCP plan details the parameters and values required for food safety at each CCP. In production, the operating limits may be different based on quality characteristics or equipment performance, but the product will be safe when critical limits are met. How do you know critical limits are met?
CCPs must be monitored
Every CCP is monitored. Common tools for monitoring are thermometers, timers, flow rate meters, pH probes, and measuring of concentration. Most quality managers want production line monitoring to be automated and continuous. If samples are taken and measured at some frequency, technicians must be trained on the sampling technique, frequency, procedure for measurement and recording of data. The values from monitoring will be compared to critical limits. If the value does not reach the critical limit, the process is out of control and food safety may be compromised. The line operator or technician should be trained to know if the line can be stopped and how to segregate product under question. Depending on the hazard, the product will be evaluated for safety, rerun, released or disposed. When the process is out of control, it is called a deviation from the HACCP plan.
A deviation initiates corrective action and documentation associated with the deviation. You can google examples of corrective action forms; there is no one form required. Basically, the line operator, technician or supervisor starts the paperwork by recording everything about the deviation, evaluation of the product, fate of the product, root cause investigation, and what was done to ensure the problem will not happen again. A supervisor or manager reviews and signs off on the corrective action. The corrective action form and associated documentation should be signed off before the product is released. Sign off is an example of verification. Verification will be discussed in more detail in a future article.
My thoughts on GMPs and HACCP were shared in a webinar on May 2nd hosted by CIJ and NEHA. Please comment on this blog post below. I love feedback!
According to a press release, the Steep Hill team announced they are expanding internationally in a big way on Monday. Steep Hill, a well-known cannabis lab-testing and research company with roots in California, announced plans for licensing agreements in Mexico, Germany, Spain, France, Italy, Switzerland and the United Kingdom.
The Canadian branch of the company, Steep Hill Canada, will lead the expansion efforts into Mexico and the six European Union countries. According to Martin Shefsky, chief executive officer of Steep Hill Worldwide, they are actively looking for other operating partners in new areas as well. “I’m extremely pleased at the opportunity to partner with Steep Hill to bring safe cannabis and scientific integrity to emerging international markets,” says Shefsky. “I anticipate that before long, full legalization will be implemented throughout the European Union and our presence will enable growers, producers, processors, and retailers – to offer standardized tested cannabis for patients and consumers across the European Union, while also enabling us to create a platform to share scientific and technology developments throughout the global cannabis market.”
In 2016, Steep Hill announced new licensing agreements to expand into Washington D.C. and Pennsylvania. In August of 2017, they expanded to Hawaii and several months later announced their expansion into Oregon. “It is an exciting time for us and our investors, as we pursue this first-mover advantage in anticipation of new global cannabis import-export markets,” says Jmîchaeĺe Keller, chief executive officer and chairman of the board of Steep Hill, Inc.
“In unregulated markets, we want to be on the ground supporting the legalization and regulatory process, helping regulators avoid making the mistakes that other jurisdictions have made in the past,” Keller says. “We believe that our role as the industry standard, allows us to leverage our world-class scientific knowledge and state of the art technology to help regulators provide confidence in the marketplace that the cannabis patients consume, is both safe and effective. We look forward to collaborating closely with Martin and his group to strive for this gold standard, across all international borders.”
Opiate abuse is a far-reaching international public health issue, impacting tens of thousands of people every year in the United States alone. As the epidemic continues to spread, the medical community is faced with the immense task of researching and developing safer, non-addictive treatment alternatives for patients of chronic pain and other ailments. The controversial and oft-debated notion of cannabis as an opiate alternative has become increasingly well-researched and gained considerable credibility in recent years. The new challenge lies in advancing the cannabis industry to the point of being a legitimate medicine that can be prescribed and administered by doctors.
Opioids are among the most commonly prescribed medical treatments for severe chronic pain, yet prescription opioid overdoses killed more than 165,000 Americans between 1999 and 2014 according to the Department of Health and Human Services. In fact, the health and social costs of opioids are estimated to be as much as $55 billion a year. As such, it has become more imperative than ever that mainstream medical practitioners take notice of the cannabis plant’s powerful healing properties and shift away from potentially harmful pharmaceutical medications.
The evidence of cannabis’ safety and efficacy is well established. For instance, in a literature review of 38 studies evaluating medical cannabis’ efficacy for treating pain, 71 percent concluded that cannabinoids had empirically demonstrable and statistically significant pain-relieving effects. In addition, a 2015 meta-analysis of 79 studies found a 30 percent or greater reduction of pain with the use of cannabinoids compared to placebos. Further, an analysis of a decade of randomized, double-blind placebo-controlled clinical trials on cannabis for treating pain concluded that cannabis should be a first line treatment for patients with painful neuropathy and other serious and debilitating symptoms, who often do not respond to other available medications.
Not only is cannabis demonstrably safe and effective, but numerous studies also present compelling evidence that the prescription of opiates has dropped sharply in U.S. states and countries that have legalized medical cannabis. For example, a study in the Clinical Journal of Pain followed 176 chronic pain patients in Israel over seven months. Researchers found that 44 percent of participants stopped taking prescription opioids within seven months after starting medical cannabis. Patients cited the following reasons for using cannabis instead of pharmaceutical drugs: 65 percent reported less adverse side effects, 57 percent cited better symptom management and 34 percent found that cannabis had less withdrawal potential than their other medications.The evidence of cannabis’ safety and efficacy is well established.
The tide is quickly turning as many respected doctors are beginning to advocate for the tremendous medical potential of cannabis as a replacement for prescription pills. That said, if the cannabis industry is to help solve the crisis inflicted by modern pharmaceutical painkillers, we must develop next-generation scientifically formulated products and advocate to improve their accessibility.
Inhalation and oral methods of cannabis consumption have no reliable dosage as medicine, rendering them unfit for administration by health professionals. These mainstream consumption methods also have extremely low bioavailability and bioactivity. Bioavailability for ingested cannabis products is only 6 percent and for inhalation methods can be as low as 2 percent. Oral absorption of THC is slow and unpredictable, with peak blood concentration occurring 1–5 hours post dose. Similarly, inhalation methods can take up to two hours to have any effect. The next phase of the medical cannabis industry must focus on fixing problems that prevent cannabis from being a universally recognized health tool. Fortunately, scientists are making major advancements in cannabis delivery technologies, offering novel and innovative administration methods that have proven both effective and reliable.
With products like Evolve’s NanoSerum representing a promising solution to help reduce the morbidity and mortality associated with prescription opioid use and abuse, meaningful progress is already underway. It’s been a long and challenging road to arrive at this point, but our efforts are only just beginning. Achieving long-term change on a national and international scale will require professionals from all levels of the cannabis, science and medical communities to push for advanced product offerings that provide consistent, standardized dosing in healthier, smokeless modes of delivery.
According to a press release, last week GW Pharmaceuticals’ drug Epidiolex received a positive FDA panel review, which is an encouraging and important step towards getting the drug approved by the U.S. Food and Drug Administration and on the market in the United States. Epidiolex is an anti-epilepsy drug, taken in a syrup form, with the main active ingredient being cannabidiol (CBD), and less than 0.1 % THC.
The drug is targeted to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) a rare early-onset type of epilepsy found in children, according to Reuters. FDA staff said the drug “reduces seizure frequency in patients with drug-resistant LGS or DS while maintaining a predictable and manageable safety profile.”
GW Pharmaceuticals, founded in 1998 and based in London, is a biopharmaceutical company that has made headlines previously for developing cannabis-derived drugs. Sativex, one of the first drugs they developed, is derived from cannabis, but was not approved by the FDA. It is however available in other parts of the world, such as the EU, Israel and Canada.
If Epidiolex actually gets approval by the FDA, it will be the first-ever cannabis-derived drug available via prescription in all of the United States. According to Justin Gover, chief executive officer of GW Pharmaceuticals, this is a momentous breakthrough for the company. “We are pleased by the Advisory Committee’s unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy,” says Gover “This favorable outcome marks an important milestone in our company’s unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA.”
According to the GW press release, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA unanimously recommended supporting the approval of the New Drug Application (NDA) for the drug. That advisory committee is sort of like an independent panel; their unanimous vote doesn’t necessarily mean the drug will get approved, but the FDA takes their decision into consideration when approving new drugs. So this panel recommendation is certainly a good sign and shows this drug could potentially be on the path to FDA approval.
Last week, Curaleaf, a medical cannabis producer and processor in Miami, Florida, announced they have earned the Safe Quality Food (SQF) Level II certification. In the press release, they claim they are the first and only medical cannabis company in the state to achieve that certification.
Curaleaf’s products include a line of low-THC and full strength medical cannabis products. They have dispensaries in Miami, Lake Worth, Fort Myers and St. Petersburg, as well as delivery of products from Jacksonville south to Key West.
According to Lindsay Jones, president of Curaleaf Florida, patients ask frequently about the level of safety of cannabis products. “Every day patients express interest and assurance of wanting to know that the foods and medicines they consume are safe and of the best quality available,” says Jones. “This SQF Level II certification that Curaleaf has earned is particularly important for patients and demonstrates that our medical marijuana processing expertise delivers superior quality products for patients in need across Florida.”
Florida’s regulations on medical cannabis producers and processors actually require a form of certification demonstrating proper food safety protocols. “Within 12 months after licensure, a medical marijuana treatment center must demonstrate to the department that all of its processing facilities have passed a Food Safety Good Manufacturing Practices, such as Global Food Safety Initiative or equivalent, inspection by a nationally accredited certifying body,” reads Rule 9 in the 2017 Florida Statute. Edibles producers in Florida “must hold a permit to operate as a food establishment pursuant to chapter 500, the Florida Food Safety Act, and must comply with all the requirements for food establishments pursuant to chapter 500 and any rules adopted thereunder.” The rules also lay out requirements for packaging, dosage and sanitation rules for storage, display and dispensing of edible products.
Looking at SQF Level II certification and GFSI could be a step in the right direction for many cannabis infused product manufacturers, as they are some of the more recognized programs in the food industry.
Many physicians today treat their patients with cannabidiol (CBD, Figure 1), a cannabinoid found in cannabis. CBD is more efficacious over traditional medications, and unlike delta-9 tetrahydrocannbinol (THC), the main psychoactive compound in cannabis, CBD has no psychoactive effects. Researchers have found CBD to be an effective treatment for conditions such as cancer pain, spasticity in multiple sclerosis, and Dravet Syndrome, a form of epilepsy.
Most manufacturers use chromatography techniques such as high performance liquid chromatography (HPLC) or flash chromatography to isolate compounds from natural product extracts. While these methods are effective for other applications, they are not, however, ideal for CBD isolate production. Crude cannabis oil contains some 400 potentially active compounds and requires pre-treatment prior to traditional chromatography purification. Both HPLC and flash chromatography also require silica resin, an expensive consumable that must be replaced once it is contaminated due to irreversible absorption of compounds from the cannabis extract. All of these factors limit the production capacity for CBD manufacturers.
Additionally, these chromatography methods use large quantities of solvents to elute natural compounds, which negatively impacts the environment.
A Superior Chromatography Method
Centrifugal partition chromatography (CPC) is an alternative chromatography method that can help commercial CBD manufacturers produce greater quantities of pure CBD more quickly and cleanly, using fewer materials and generating less toxic waste. CPC is a highly scalable CBD production process that is environmentally and economically sustainable.
The mechanics of a CPC run are analogous to the mechanics of a standard elution using a traditional chromatography column. While HPLC, for instance, involves eluting cannabis oil through a resin-packed chromatography column, CPC instead elutes the oil through a series of cells embedded into a stack of rotating disks. These cells contain a liquid stationary phase composed of a commonly used fluid such as water, methanol, or heptane, which is held in place by a centrifugal force. A liquid mobile phase migrates from cell to cell as the stacked disks spin. Compounds with greater affinity to the mobile phase are not retained by the stationary phase and pass through the column faster, whereas compounds with a greater affinity to the stationary phase are retained and pass through the column slower, thereby distributing themselves in separate cells (Figure 2).
A chemist can choose a biphasic solvent system that will optimize the separation of a target compound such as CBD to extract relatively pure CBD from a cannabis extract in one step. In one small-scale study, researchers injected five grams of crude cannabis oil low in CBD content into a CPC system and obtained 205 milligrams of over 95% pure CBD in 10 minutes.
The solvents used in chromatography, such as methanol and acetonitrile, are toxic to both humans and the environment. Many environmentally-conscious companies have attempted to replace these toxic solvents with greener alternatives, but these may come with drawbacks. The standard, toxic solvents are so common because they are integral for optimizing purity. Replacing a solvent with an alternative could, therefore, diminish purity and yield. Consequently, a chemist may need to perform additional steps to achieve the same quality and quantity achievable with a toxic solvent. This produces more waste, offsetting the original intent of using the green solvent.
CPC uses the same solvents as traditional chromatography, but it uses them in smaller quantities. Furthermore, as previously mentioned, these solvents can be reused. Hence, the method is effective, more environmentally-friendly, andeconomically feasible.
CPC’s Value in CBD Production
As manufacturers seek to produce larger quantities of pure CBD to meet the demand of patients and physicians, they will need to integrate CPC into their purification workflows. Since CPC produces a relativelyduct on a larger scale, it is equipped to handle the high-volume needs of a large manufacturer. Additionally, because it extracts more CBD from a given volume of raw cannabis extract, and does not use costly silica or require multiple replacement columns, CPC also makes the process of industrial-scale CBD production economically sustainable. Since it also uses significantly less solvent than traditional chromatography, CPC makes it financially feasible to make the process of producing CBD more environmentally-friendly.
The International Cannabis Business Conference (ICBC) in Berlin is now officially over. The speeches have been made, the parties have been attended. The hard-working crew behind it all has wrapped up, checked out and is off to Vancouver. And most of all, the marathon of meetings and deal discussions that were the mark of this budding and certainly by now established market are done. Even if there are still details to be ironed out in all the new business in the coming months.
As always, the dilemma for conference attendees was how to spend the limited time in this concentrated cannabis gathering. With all of the networking and excitement, people still wanted to hear the experts who spoke on topics ranging from cannabis financing to actually doing business in Germany to new medical advances. Traffic in the expo section was also heavy, as attendees visited the wide range of vendors. Producers and distributors of both plant and derived product were present, along with vape companies brave enough to compete with Storz and Bickel on their own turf, various tech solutions and of course, international consultants.
As the dust clears and the contracts get signed, what are the takeaways from the second edition of the ICBC in Berlin?
Germany Is Going Green
The simplest takeaway? The ICBC Berlin is not a market to be missed in the future for the global cannabis executive. Even if you are an American firm (and for the most part still largely excluded from a rapidly expanding worldwide trade that is establishing itself now with authority), you need to be here. The contacts you make are global, and you do not want to be left out. For foreign investors interested in this market, it is a must. For everyone else, this is a meet and greet, not to mention education, barnone. The German medical and even prosumer CBD market is attracting the world.
Yes, there have been ups and downs even in the last three weeks that include the crashing of the German bid along with news stateside that the Trump Administration is going to hang Jeff Sessions out to dry for Russia with his latest “Make American States Great For Cannabis Again” contortion.
But here on the other side of the Atlantic, it is clear that the federal cannabinoid horse has left the barn. There are now rumorsfloating that the bid is not yet entirely dead (now apparently in a legal purgatory of appeals and even potentially “bid amendments”) that nobody is willing to go on record to discuss. Beyond that, however, as was clear from the frenzied deal-makingon the floor and off it at the ICBC, the market is open, distributors are finding new channels to move product, and patients demanding access are not leaving the streets.
Far from it. In fact, the budding nascent umbrella national non-profit campaign designed to open access for patients and educate doctors, The German Patients Roundtable, had a huge second meeting during the conference, with both German and international attendees from countries including Israel and South Africa.
The CBD and THC genie cannot be stuffed back into the local bottle. And everyone knows it. This is federal medical reform, and even better, covered under German national public health insurance. Despite the hiccups and challenges that still remain, this is open blue water for a medical market that has never existed anywhere to date.
Anyone with a GMP facility, Euro cleared export rights and crop or product ready to ship will be welcome here in a market that at this point, cannot get enough plant or oil. Edibles are still a to-come discussion.
To the extent that this is also negative, it is very clear that the market is still highly inefficient. Producers who do have productare not being found by those on the ground who want to sell it to patients. That will also begin to change. But for now, many on the ground are playing a digitalized Rolodex game of “who do you know” that still consists of personal emails between conference-met colleagues if not LinkedIn contacts and impromptu (and freebie) favors. Those who hope to gain an income merely by connecting the source of product and outlets the old fashioned way are also about to be left in the dust by a market that will not be held back and activist businesses who are eyeing both the United States and Canada right now (if not Israel and Australia), and translating all of that into both euros and German.
It is also very clear that the savvy Germans who were largely left out of the bid proceedings last time do not mean to sit this party out – and are angling to get into the game however they can. This is taking some interesting forms, but processing and testing are going to be huge issues of the market here for a long time to come. And so is home-grown, high-quality CBD. The German government is even offering tax credits for growing certain kinds of hempright now. Sound familiar Kentucky?
Trends and Takeaways
It is not just the Canadians who are going to get market share. The Canadian LPs are still in a good position to dominate the early market but it is clear that there is still room for others to enter. Whether the government allows an appeal of the court’s decision to hold up, there is a quick bid “redo” for the top 10 finalists, or a second bid, the market has now arrived and is in its second year.
CBD is going to be an important path to other kinds of provision and cultivation. Despite the widespread misconceptions about Germany being a “CBD only” market (it is not), it is clear that a consumer CBD only strategy will be an interesting path into the market here but not one for the faint of heart. The Canadian companies in particular are beginning to move into the realm of big pharma (their market caps certainly are). But it is also clear that more local competition is hip to the same. And as a result, even this part of the market will be a highly competitive one.
German firms are first at this gate, beyond the big Canadian LPs, but they are not the only ones now in the market. See Dutch, Austrian and Swiss firms, many with pharmaceutical company credits and market entry already under their belt. Not to mention producers from both Greece and the Baltics. Everyone on the import side is eyeing the opening market and stalled bid as a fantastic opportunity. Look for products from these locales as testing and certification protocols become more effective.
Central to all of these developments? The conference is theplacefor the global cannabis industry to meet and get to know one another, put together by Alex Rogers and a seasoned, international team behind the ICBC.
Have you ever wondered why all beers have that strong, characteristic smell? Or why you could tell the smell of cannabis apart from any other plant? The answer is simple – terpenes.
These 55,000 different molecules are responsible for a majority of the odors and fragrances around us, from a pine forest, to the air diffuser in your house 1–3. They all share the same precursor, isoprene, and because of that, they are all related and have similar molecular structures. Unfortunately, it is this uncanny similarity that makes their analysis so challenging; we still lack a complete list of which terpenes expected to be found in each given plant species 1,2.
Many different methods have been developed in an effort to provide a time-optimized and straightforward analysis. Gas chromatography (GC) is usually center stage due to the volatility of the terpenes. Therefore, there is significant concern with the type of GC detector used 2.
The flame ionization detector (FID) is a good quantitative detector for GC, but qualitatively it does not provide any information, except for retention time; the differentiation between terpene species is achieved solely by use of retention indices (RI), which are based on elution times from a particular GC stationary phase. The best part of the FID is its low cost, reliability, and relatively easy interface, which make it an effective tool for quality control (QC) but less so with respect to research and discovery 2.
The primary choice for a research setting is the mass spectrometer (MS) detector. It is more expensive and complicated than FID, but importantly, it provides both good quantitative capabilities, and it provides mass spectra for each species that elutes from the chromatograph. However, for terpene analysis, it may still not be the best detector choice. Since terpene class molecules share many structural and functional similarities, even their fragmentation and sub-sequential identification by MS may lead to inconsistent results, which need to be confirmed by use of RI. Still, MS is a better qualitative analysis tool than the FID, especially for distinguishing non-isobaric terpenes 2.
Recently, new technology based on vacuum ultraviolet spectroscopy (VUV) has been developed as a new GC detector. The VUV detector enables analysis of virtually all molecules; virtually all chemical compounds absorb light in the range in the 125-240 nm wavelength range probed by the detector, making it an essentially universal detector 4–11. Previously, spectroscopic absorption detectors for GC have lacked sufficient energy to measure absorption of most GC-amenable species. The VUV detector fills a niche, which is complementary to MS detection in terms of the qualitative information it provides.
With the VUV detector, each compound exhibits its own unique absorbance spectrum. Even isomers and isobars, which are prevalent in terpene mixtures and can be difficult to distinguish different species by their electron ionization mass spectra, can be well differentiated based on their VUV spectra 6,9,10. Nevertheless, because analytes exhibit different spectra, it is not required to achieve a perfect chromatographic separation of the mixture components. Co-eluting peaks can be separated post-run through the use of library spectra and software inherent to the instrument 4,10. This ability is called “deconvolution”, and it is based on the fact that two co-eluting terpenes will give a peak with an absorbance spectrum equal to the sum of the two single absorbance spectra 4. Figure 1 shows the deconvolution process for two co-eluting terpenes, camphor and (-)-isopulegol. Due to their different absorbance spectra (Figure 1C), it is possible to fully separate the two peaks in post-run, obtaining sharp peaks for both analytes 6.
The deconvolution process has been shown to yield precise and accurate results. Thus, chromatographic resolution can be sacrificed in favor of spectroscopic resolution; this enables the development of methods with faster run times. With the ability to deconvolve unresolved peaks, a long temperature ramp to chromatographically separate all isomeric terpenes is not required 6. Additionally, the presence of coeluting components, which might normally go undetected with some GC detectors, can be easily judged based on comparison of the measured spectra with pure reference spectra contained in the VUV spectral library.
The other issue in terpenes analysis is the extraction process. Terpenes can be extracted with the use of solvents (e.g., methanol, ethanol, hexane, and cyclohexane, among others), but the process is usually time-consuming, costly and not so environmentally-friendly 2. The plant needs to be manually crushed and then aliquots of solvent are used to extract components from the plant, ideally at least 3 times and combined to achieve acceptable results. The problem is that some terpenes may respond better to a certain solvent, making their extraction easier and more optimized than for others 2. The choice of solvent can cause discrimination against the extraction some terpenes, which limits the comprehensiveness of analysis.
Headspace is another technique that can be used for the sample preparation of terpenes. Headspace sampling is based on heating the solid or liquid sample inside a sealed vial, and then analyzing the air above it after sufficient equilibration. In this way, only volatile analytes are extracted from the solid/liquid sample into the gas phase; this allows relatively interference-free sampling 12–14.
How do we know whether our extraction analysis methods are correct and comprehensive for a certain plant sample? Unfortunately, there is not a complete list of available molecules for each plant species, and even if two specimens may smell really similar to our nose, their terpenes profiles may be notably different. When working with a new plant material, it is difficult to predict the extraction efficiency for the vast array of terpenes that may be present. We can only perform it with different extraction and detection methods, and compare the results.
The route for a comprehensive and fast analysis of terpenes is therefore still long; however, their intoxicating aromas and inherent medicinal value has provided a growing impetus for researchers around the world. Considering the evolving importance of Cannabis and the growing body of evidence on the synergistic effects between terpenes and cannabinoids, it is likely that newly improved extraction and analysis methods will be developed, paving the way for a more complete list of terpene species that can be found in different cultivars. The use of new analytical technologies, such as the VUV detector for GC, should aid considerably in this endeavor.
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