Tag Archives: extraction

October 24, 2019

Rapid Pathogen Detection for the 21st Century: A Look at PathogenDx

By Aaron G. Biros

In 1887, Julius Petri invented a couple of glass dishes, designed to grow bacteria in a reproducible, consistent environment. The Petri dish, as it came to be known, birthed the scientific practice of agar cultures, allowing scientists to study bacteria and viruses. The field of microbiology was able to flourish with this handy new tool. The Petri dish, along with advancements in our understanding of microbiology, later developed into the modern field of microbial testing, allowing scientists to understand and measure microbial colonies to detect harmful pathogens in our food and water, like E. coli and Salmonella, for example.

The global food supply chain moves much faster today than it did in the late 19^th century. According to Milan Patel, CEO of PathogenDx, this calls for something a little quicker. “Traditional microbial testing is tedious and lengthy,” says Patel. “We need 21^st century pathogen detection solutions.”

Milan Patel first joined the parent company of PathogenDx back in 2012, when they were more focused on clinical diagnostics. “The company was predominantly built on grant funding [a $12 million grant from the National Institute of Health] and focused on a niche market that was very specialized and small in terms of market size and opportunity,” says Patel. “I realized that the technology had a much greater opportunity in a larger market.”

Milan Patel, CEO of PathogenDx
Photo: Michael Chansley

He thought that other markets could benefit from that technology greatly, so the parent company licensed the technology and that is how PathogenDx was formed. Him and his team wanted to bring the product to market without having to obtain FDA regulatory approval, so they looked to the cannabis market. “What we realized was we were solving a ‘massive’ bottleneck issue where the microbial test was the ‘longest test’ out of all the tests required in that industry, taking 3-6 days,” says Patel. “We ultimately realized that this challenge was endemic in every market – food, agriculture, water, etc. – and that the world was using a 140-year-old solution in the form of petri dish testing for microbial organisms to address challenges of industries and markets demanding faster turnaround of results, better accuracy, and lower cost- and that is the technology PathogenDx has invented and developed.”

While originally a spinoff technology designed for clinical diagnostics, they deployed the technology in cannabis testing labs early on. The purpose was to simplify the process of testing in an easy approach, with an ultra-low cost and higher throughput. Their technology delivers microbial results in less than 6 hours compared to 24-36 hours for next best option.

Out of all the tests performed in a licensed cannabis testing laboratory, microbial tests are the longest, sometimes taking up to a few days. “Other tests in the laboratory can usually be done in 2-4 hours, so growers would never get their microbial testing results on time,” says Patel. “We developed this technology that gets results in 6 hours. The FDA has never seen something like this. It is a very disruptive technology.”

When it comes to microbial contamination, timing is everything. “By the time Petri dish results are in, the supply chain is already in motion and products are moving downstream to distributors and retailers,” Patel says. “With a 6-hour turnaround time, we can identify where exactly in the supply chain contaminant is occurring and spreading.”

The technology is easy to use for a lab technician, which allows for a standard process on one platform that is accurate, consistent and reproduceable. The technology can deliver results with essentially just 12 steps:

Take 1 gram of cannabis flower or non-flower sample. Or take environmental swab
Drop sample in solution. Swab should already be in solution
Vortex
Transfer 1ml of solution into 1.5ml tube
A look at how the sample is added to the microarray
Conduct two 3-minute centrifugation steps to separate leaf material, free-floating DNA and create a small pellet with live cells
Conduct cell lysis by adding digestion buffer to sample on heat blocks for 1 hour
Conduct Loci enhancement PCR of sample for 1 hour
Conduct Labelling PCR which essentially attaches a fluorescent tag on the analyte DNA for 1 hour
Pipette into the Multiplex microarray well where hybridization of sample to probes for 30 minutes
Conduct wash cycle for 15 minutes
Dry and image the slide in imager
The imager will create a TIFF file where software will analyze and deliver results and a report

Their DetectX product can test for a number of pathogens in parallel in the same sample at the same time down to 1 colony forming unit (CFU) per gram. For bacteria, the bacterial kit can detect E. coli, E. coli/Shigella spp., Salmonella enterica, Listeria and Staph aureus, Stec 1 and Stec 2 E.coli. For yeast and mold, the fungal kit can test for Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger and Aspergillus terreus.

Their QuantX is the world’s first and only multiplex quantification microarray product that can quantify the microbial contamination load for key organisms such as total aerobic bacteria, total yeast & mold, bile tolerant gram negative, total coliform and total Enterobacteriaceae over a dynamic range from 100 CFU/mL up to 1,000,000 CFU/mL.

Not all of the PathogenDx technology is designed for just microbial testing of cannabis or food products. Their EnviroX technology is designed to help growers, processors or producers across any industry identify areas of microbial contamination, being used as a tool for quality assurance and hazard analysis. They conducted industry-wide surveys of the pathogens that are creating problems for cultivators and came up with a list of more than 50 bacterial and fungal pathogens that the EnviroX assay can test for to help growers identify contamination hotspots in their facilities.

Using the EnviroX assay, growers can swab surfaces like vents, fans, racks, workbenches and other potential areas of contamination where plants come in contact. This helps growers identify potential areas of contamination and remediate those locations. Patel says the tool could help growers employ more efficient standard operating procedures with sanitation and sterilization, reducing the facility’s incidence of pathogens winding up on crops, as well as reduction in use of pesticides and fungicides on the product.

Deploying this technology in the cannabis industry allowed Milan Patel and the PathogenDx team to bring something new to the world of microbial testing. Their products are now in more than 90 laboratories throughout the country. The success of this technology provides another shining example of how the cannabis market produces innovative and disruptive ideas that have a major impact on the world, far beyond cannabis itself.

October 23, 2019

A Year In Review: Canadian Recreational Reform Year 1

By Marguerite Arnold

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There is certainly, in retrospect, much to be proud about in Canada – home of one of the most disruptive international cannabis industries in the world. And certainly an early mover.

That starts with having the national mojo to begin this journey in the first place, not to mention pivot and even admit faults along the way. For all the complaints and whinges, however on the ground, most Canadians are proud that they tackled the canna question at a federal level.

As the industry now does a bit of an annual review and revisit, what are some of the largest accomplishments, takeaways (and let’s be honest, major f*ckups) so far? And where is this all headed as the industry at least tries to gear up for another year, if not quite Cannabis 2.0?

The Big Bravos

Launching in the first place. Yes Full Monty Recreational was scary, and delayed a few months last year. And even though there have been many problems (retail outlets, online sales, privacy, supply chain issues in every direction, ex im, foreign markets and etc.), it is up and running.

In comparison, the Brits have been haranguing over Brexit for the last three years and are still not really there.

Further, it is also apparent that the agencies in charge of the new industry are themselves giving a bit of a shake after CannaTitanic (CannTrust). That was embarrassing for them too, although of course, while a bit of a negative compliment, the recall system seems to work.

Even if it needs a few jump starts via whistleblowing.

That in and of itself is a fact that is still in the room, although perhaps the pancaking of the stock price of most of the public industry of late was also another much needed wakeup call.

The Devil In The Details

Domestic Requirements. Health Canada is getting hip to the fact that the industry needs a bit more of a heavy hand. See the book thrown at CannTrust. No matter what, Canadians are demanding to know where their cannabis comes from, and further are also demanding that it be at least free of pesticides that can harm them.

Licensing. Many cannapreneuers are complaining, still, about the delays in licensing, particularly for retail outlets in the provinces who are taking the cannabull by the horns. That said, there are still lots of enterprises who are perfectly happy to dodge the requirements all together and sell to the black or gray market. No licensing fees, and no taxes is a wonderful dream, but that is not exactly how regulated democratic capitalism works – at least at this level.

Supply Chain Logistics and Related Technologies. Canadians are struggling to implement a regulated industry in a country where patient home grow is constitutionally protected, and in an environment where who can sell what, and to whom including online, is still evolving. Predictably, no matter how groovy the solution works at home, (or the U.S.), no it will not fly in Europe. See GDPR regs, for starters.

Seed Culture (Aka Strain Protection). No matter how much the lawyers in the colonies are gearing up to sue each other over Huey’s Half Baked, in Europe, there are tomato and pepper farmers who are laughing, literally, all the way to the bank on this one. While hip to be a “strain defender,” the reality in a medical market looking for cheap cannabinoids is rather different. Effective, clean product, which can be reproduced reliably and cheaply, is the name of the game. Girl Scout Cookies, and such ilks will be a long time in coming as anything but highly expensive, niche products you can find in a Dutch Coffee Shop.

Domestic Requirements Vs International Export. Canadian standards, so far, have been widely divergent in an environment where exports to Europe in particular are part of the story for the biggest companies. That said, GMP, and in particular EU GMP, has become at least a buzzword if not a standard to live up to.

Privacy. California might be considering its own form of GDPR (European privacy legislation) but so far, the industry has largely failed to protect consumers (from themselves). Ideas about owning huge data troves on cannabis users for someone else’s profit are still very much in the room. After all, data is the new oil, whether people know their data is being harvested or not. And just like big oil has done for most of its existence, those in the driver’s seat so far show little compunction about harvesting personal information, to become in the words of the now departed CEO of Canopy Growth Bruce Linton, “the Google of Cannabis.” Won’t happen. Starting with the fact that in not just Europe but now even California, people, far beyond pot users are tired of a world where privacy is a second class right.

While the issue first hit in Canada on the recreational side, the reality is that companies know who their clients and patients are in a way that is not only disturbing but increasingly being challenged.

October 21, 2019

3 Essential Components of Microbial Safety Testing

By Heather Ebling

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Microbial contamination on cannabis products represents one of the most significant threats to cannabis consumers, particularly immunocompromised patients who are at risk of developing harmful and potentially fatal infections.

As a result, regulatory bodies in the United States and Canada mandate testing cannabis products for certain microbes. The two most popular methods for microbial safety testing in the cannabis industry are culture-based testing and quantitative polymerase chain reaction (qPCR).

When considering patient safety, labs should choose a method that provides an accurate account of what is living on the sample and can specifically target the most harmful microbes, regardless of the matrix.

1. The Method’s Results Must Accurately Reflect the Microbial Population on the Sample

The main objective of any microbial safety test is to give the operator an indication of the microbial population present on the sample.

Figure 1: MA data collected directly from plant material before and after culture on 3M petrifilm and culture-based platforms.

Culture-based methods measure contamination by observing how many organisms grow in a given medium. However, not all microbial organisms grow at the same rate. In some cases, certain organisms will out-compete others and as a result, the population in a post-culture environment is radically different than what was on the original sample.

One study analyzed fifteen medicinal cannabis samples using two commercially available culture-based methods. To enumerate and differentiate bacteria and fungi present before and after growth on culture-based media, all samples were further subjected to next-generation sequencing (NGS) and metagenomic analyses (MA). Figure 1 illustrates MA data collected directly from plant material before and after culture on 3M petrifilm and culture-based platforms.

The results demonstrate substantial shifts in bacterial and fungal growth after culturing on the 3M petrifilm and culture-based platforms. Thus, the final composition of microbes after culturing is markedly different from the starting sample. Most concerning is the frequent identification of bacterial species in systems designed for the exclusive quantification of yeast and mold, as quantified by elevated total aerobic count (TAC) Cq values after culture in the total yeast and mold (TYM) medium. The presence of bacterial colonies on TYM growth plates or cartridges may falsely increase the rejection rate of cannabis samples for fungal contamination. These observations call into question the specificity claims of these platforms.

The Live Dead Problem

Figure 2: The enzyme is instantaneously inactivated when lysis buffer is added

One of the common objections to using qPCR for microbial safety testing is the fact that the method does not distinguish between live and dead DNA. PCR primers and probes will amplify any DNA in the sample that matches the target sequence, regardless of viability. Critics claim that this can lead to false positives because DNA from non-viable organisms can inflate results. This is often called the Live-Dead problem. However, scientists have developed multiple solutions to this problem. Most recently, Medicinal Genomics developed the Grim Reefer Free DNA Removal Kit, which eliminates free DNA contained in a sample by simply adding an enzyme and buffer and incubating for 10 minutes. The enzyme is instantaneously inactivated when lysis buffer is added, which prevents the Grim Reefer Enzyme from eliminating DNA when the viable cells are lysed (see Figure 2).

2. Method Must Be Able to Detect Specific Harmful Species

Toxic Aspergillus spp., which is responsible for at least one confirmed death of a cannabis patient, grows poorly in culture mediums and is severely underreported by current culture-based platforms. And even when Aspergillus does grow in culture, there is a certain non-pathogenic Aspergillus species that look remarkably similar to their pathogenic cousins, making it difficult to speciate using visual identification alone.

Conversely, qPCR assays, such as the PathoSEEK, are designed to target DNA sequences that are unique to pathogenic Aspergillus species, and they can be run using standard qPCR instruments such as the Agilent AriaMx. The primers are so specific that a single DNA base difference in the sequence can determine whether binding occurs. This specificity reduces the frequency of false positives in pathogen detection, a frequent problem with culture-based cannabis testing methods.

Additionally, Medicinal Genomics has developed a multiplex assay that can detect the four pathogenic species of Aspergillus (A. flavus, A. fumigatus, A. niger, and A. terreus) in a single reaction.

3. The Method Must Work on Multiple Matrices

Figure 4: The team also placed TSB without any E. coli onto a petrifilm to serve as a control.

Marijuana infused products (MIPs) are a very diverse class of matrices that behave very differently than cannabis flowers. Gummy bears, chocolates, oils and tinctures all present different challenges to culture-based techniques as the sugars and carbohydrates can radically alter the carbon sources available for growth. To assess the impact of MIPs on colony-forming units per gram of sample (CFU/g) enumeration, The Medicinal Genomics team spiked a known amount of live E. coli into three different environments: tryptic soy broth (TSB), hemp oil and hard candy. The team then homogenized the samples, pipetted amounts from each onto 3M™ Petrifilm E. coli / Coliform Count (EC) Plates, and incubated for 96 hours. The team also placed TSB without any E. coli onto a petrifilm to serve as a control. Figures 3 and 4 show the results in 24-hour intervals.

Table 1: DNA was spiked into various MIPs

This implies the MIPs are interfering with the reporter assay on the films or that the MIPs are antiseptic in nature.

Many MIPs use citric acid as a flavoring ingredient which may interfere with 3M reporter chemistry. In contrast, the qPCR signal from the Agilent AriaMx was constant, implying there is microbial contamination present on the films, but the colony formation or reporting is inhibited.

Table 3: SenSATIVAx DNA extraction can successfully lyse the cells of the microbes

Table 2: Different numbers of DNA copies spiked into chocolate

This is not an issue with DNA-based methods, so long as the DNA extraction method has been validated on these matrices. For example, the SenSATIVAx DNA extraction method is efficient in different matrices, DNA was spiked into various MIPs as shown in Table 1, and at different numbers of DNA copies into chocolate (Table 2). The SenSATIVAx DNA extraction kit successfully captures the varying levels of DNA, and the PathoSEEK detection assay can successfully detect that range of DNA. Table 3 demonstrates that SenSATIVAx DNA extraction can successfully lyse the cells of the microbes that may be present on cannabis for a variety of organisms spiked onto cannabis flower samples.

October 18, 2019

Safeguarding Your International Supply Chain: The Brave New World Of Cannabis Compliance

By Marguerite Arnold

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The CannTrust story may have shocked the uninitiated, but it hit almost every bogeyman the legitimizing industry has both feared and suffered from, particularly of late.

Here, generally, is the issue. Especially in Europe (even more especially in places like Germany, the UK and other emerging markets), budding cannapreneurs need each other. A distributor in Germany, for example, cannot get their final (federal) licenses allowing them to do business without establishing a relationship with an existing producer. That producer also needs relationships with established distributors to get their licenses.

In a fraught world, where all parties are evolving rapidly (and this also includes the “Big Boys” from Canada and several U.S. states including California), supply chain logistics, and even contract agreements if not licensing beyond that requires a level of honesty, integrity and transparency the industry, largely has not achieved yet.

That said, there are also parties, if not individuals and companies determined to set themselves on the straight and narrow – and play by the emerging “rules” – and then there are also clearly companies which, well, do not.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.What this brave new world of cannabis requires, however, and from everyone – from grower, to manufacturer, packager, distributor and service delivery – is that all ecosystem partners must be in compliance.

Ensuring that can be a full time job. But what it also means is that to have a fully compliant product, every party in the chain bears responsibility for upholding standards that so far have proved hard to reach for many.

The time has come, in other words, where that is no longer an option.

The First Step Is Certification…

In a world where every member of the diverse cannabis ecosystem requires certification, determining what, and from whom is the first hurdle – both for buyer and seller. If one has GMP-certified product, that is awesome. But there are also treaties in the room that only allow some GMP certifications to be considered equal to others. If you are in Lesotho right now, for example, far from Europe, your biggest concern is not just looking to the EU but figuring out a way to export your crop into your neighbouring (and surrounding) country – namely South Africa.

This example, while seemingly far away, in fact, is the biggest bugbear in determining who can sell to whom even within Europe (let alone countries just outside and far beyond the region).

Determining cert presence, if not validity, however, is only the tip of the iceberg. And depending on who you are, that path alone is not a one time dalliance with authorities, but multiple certifications that must all also be kept current.

But It is Not The Only One…

The second hurdle, of course, is also checking the verity of everyone you do business with. For a producer, this includes making sure that processing, packaging, and even transportation are in compliance. In Canada, of course, this has been short circuited by the ability of producers to ship directly to patients.

In Europe, however, this is far from the case. And that is also why the entire conversation is also getting not only much more granular, but expensive. Pharmaceutical regulations are actually what guide the rules of the road here.

Walking floors, and checking, in person, may or not be mandated by international treaties at this point. However, most of the young producers on the ground here are implementing policies of personal visits to their vendors. In Massachusetts of late, this is also on the drawing board. Albeit on a “state” level, the reality is that both federal, state and more local training is a watchword, if not a must, now on the roadmap.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.

And while that obviously is a challenge, companies must step up to the plate internally to commit to the same. It is too dangerous to ignore such steps. Including the easy to reach ones, like staff background checks and decent cybersecurity safeguards. The former has blown several enterprising cannadudes out of the driver’s seat already in Europe over the last few years. The latter is an emerging threat in a region that is also home to GDPR regulation (and growing fines).

For that very reason, certainly on the ground in Germany if not across Europe and in those countries and companies that wish to supply the same, supply chain verification, that is constant, consistent and verifiable, is the path for the industry both as of now and in the immediate future.

October 17, 2019

A Regulatory Tsunami is Washing Over the Canadian Cannabis Industry

By Steven Burton

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On August 29, 2019, Health Canada finally published a guidance document on the official interpretation of Part 5 of the Cannabis Regulations concerning “Good Production Practices” that comes into force just seven weeks later on October 17, 2019. For those watching with the experience of the food industry, it is safe to say that few license holders fully appreciate the magnitude of the new requirements and fewer yet are prepared for what will be required in less than two weeks.

An Uncertain Road to Cannabis Compliance

Since Canada legalized recreational cannabis in October 2018, there has been considerable uncertainty about the road to compliance in this totally new legal market. Health Canada faced the daunting challenge of defining the requirements for a whole new industry, and so they were understandably silent on the issue of Part 5 until this guide was published in August.

Many larger companies eager to get their foot in the door of the multi-billion dollar industry tried to be proactive in anticipating impending government regulations by seeking Good Manufacturing Practices (GMP) certifications. This would likely have been fine under the previous regulations, which were myopically focused on ensuring that product wasn’t diverted from or to the black market. With the legalization of edibles only one year away, however, it was obvious to those in the food industry that GMP was just not going to be enough. Gentle prodding at various speaking engagements on our part wasn’t enough to convince these companies to seek higher levels of certification or at least to proactively develop the organizational culture required to support a higher-level program.

The Inevitable Necessity of Food Safety

It was clear to us that since edibles are essentially a food product, safety necessarily had to become a primary focus. This reality has, in fact, materialized in section 5 of the new guide, which outlines prescriptive requirements that are very well developed and require that companies develop a complete set of Standard Operating Procedures (SOPs) for sanitation, employee hygiene, testing, inventory, pest control and more. Furthermore, cannabis companies must be able to produce documentation that proves they are actually following these procedures.

There are many, many other requirements that also apply, but the really interesting ones are those related to hazard analysis (5.2.13) and preventive control plans (5.2.14): manufacturers who produce extracts or edibles must undertake hazard analyses on each input, processing step and traffic flow. The language will be familiar to those who have been exposed to Hazard Analysis and Critical Control Point (HACCP) methodology. HACCP is the standard in the food industry and goes far beyond simple GMP.

Very much like HACCP, license holders will be required to analyze each biological, chemical and physical hazard, determine controls, identify critical control point, along will all the validation, reassessment, verification and deviation protocols required. Interestingly, the fraud and bioterrorism hazard types that have recently been introduced for the food industry have been omitted, presumably an oversight that will be rectified in future versions.

How to Catch Up Fast with Tech

Satisfying these regulations using traditional manual methods takes months or even years in some cases. Today in Canada, license holders have only weeks to get their facilities to compliance, and the government is quick to crack down on any mistakes. The only way to possibly meet this deadline is to start yesterday and use the best tools you can find to expedite the process.

Those who have been busy implementing GMP programs are going to have to look far beyond their current objectives. Those just starting out should build with these requirements front of mind, both to satisfy inspectors and auditors and also to avoid the pain of the organizational change required to move to a higher level of quality and safety.

Ultimately, these changes will be of benefit to society and provide a competitive advantage to those who can move the fastest, especially when major retail chains become the dominant wholesale market. My advice is to start working on your HACCP-based compliance program immediately and, if you’re in Canada, seek a high-level certification like SQF as soon as possible.

It’s fair to say that the food industry’s recent experiences with more stringent regulations clearly foreshadow what will be required for the cannabis industry. Right now – when the margin of error is razor thin – is the time for companies to make the decisive move and focus on their success – and survival.

October 16, 2019

Navigating Cannabis Staffing and Hiring Challenges

By Michael Coleman

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With more cannabis staffing and recruiting challenges than ever before, building a healthy pipeline of top candidates can be an uphill battle. From a lack of qualified candidates and working capital to the haze of lingering stigma and industry volatility, cannabis hiring and retention challenges are more apparent than ever.

Understanding the pain points of cannabis staffing and how to flip them in your favor is critical for attracting the talent you need to grow your business.

Emerging Candidate Concerns

Low unemployment coupled with high demand for qualified talent has led to fierce competition among cannabis hiring managers and HR professionals. This means finding candidates with the right skills and industry experience can be exceptionally difficult.

Dispensary and budtender jobs are some of the most popular entry-level cannabis employment opportunities. But since these are customer-facing roles, the requirements to work in a dispensary span a range of skillsets.

Not only do candidates need excellent interpersonal skills, they should also have a deep understanding of the differences and synergies in strains, terpene profiles and cannabinoid contents. The starting hourly pay for these retail dispensary jobs is only about $12-16 per hour. Finding candidates with relevant dispensary experience at such a low rate is not an easy feat.

Then there are the extractors and directors of extraction. While these positions are higher-paying than dispensary jobs, they are more dangerous and require a more specific skillset. Engaging qualified candidates for this high-risk position can take a lot of time and effort. In addition, employers also have to assume liabilities and higher compensation demands.

Other cannabis employment types that staffing departments and agencies have to hire are highly specialized.

Not only do you need talented and knowledgeable salespeople, marketers and accountants, there are also laboratory workers, trimmers, cultivation laborers and supervisors, master growers, dispensary managers and delivery drivers to account for.

Lack of Working Capital

With market demand continuing to rise, having the manpower in place is vital to remain competitive. But hiring costs money. Recruiting, advertising and interviewing requires adequate cannabis funding and/or working capital. Unfortunately, obtaining and securing capital to grow and hire is difficult in the industry today.

Making the wrong hiring decision can be costly. If you break any laws during the recruiting process, you can get hit with a hefty lawsuit. The majority of industry players today are startups with limited financial resources. A lawsuit can mean shutting down shop and going out of business.

The Volatile Nature of the Industry

The advancement and adoption of cannabis legislation are rapidly underway for medical use, recreational use and everything in between.

With shifting public sentiments, state-specific cannabis laws and licensing requirements, the industry is in a constant state of change. Even the requirements to work in the cannabis industry vary from state to state.

The ever-rising tide of volatility makes it difficult for companies to find enough stability to make responsible hiring decisions. One regulatory revision can require a company to pivot its branding, product line and entire marketing strategy from top to bottom. A shift in strategy can mean a shift in employee requirements and skillsets. This instability tends to be unappealing to candidates who are accustomed to a well-established workplace structure and culture.

With so much volatility and uncertainty, prioritizing employee relationship management seems like a wise decision. But in-house cannabis human resources is just not in the cards in many cases. Instead, cannabis staffing, recruiting and HR tend to be outsourced along with accounting and compliance.

Lack of Suitable Cannabis Recruiting Platforms

While perceptions are changing, misconceptions about the industry are still pervasive.

Lingering market stigma presents a grave challenge for cannabis staffing and hiring. In fact, many mainstream recruiting platforms are unwilling to partner with cannabis companies. Fortunately, there are some relatively new cannabis HR agencies and platforms to help solve some of the challenges of hiring in cannabis. Vangst GIGS, for example, is the first and only fully-compliant cannabis staffing platform. The CBD staffing agency has been up and running for just a few years now.

Future of Cannabis Staffing and Hiring Demands

While hemp-derived CBD has been legal since the signing of the 2018 U.S. Farm Bill, marijuana-derived CBD is still illegal. But this may change sooner rather than later.

There is growing bipartisan support for the legalization and regulation of cannabis. Beyond improving quality assurance and resolving the disconnect between state and federal laws, federal cannabis legalization will have a profound impact on the U.S. economy.

In fact, New Frontier Data projects federal legalization will create $128.8 billion in additional tax revenue and 1.63 million legal cannabis jobs in the U.S. by 2025.

Cannabis payroll deductions could also increase to $9.5 billion by 2025 because more legal entities, customers and employees would be participating in the market.

With federal legislation likely coming in the near future, knowing how to navigate and scale cannabis human resources, including hemp staffing, are more important than ever. You need the right people and processes to take advantage of the market opportunities legalization would create.

Companies that adapt to industry changes will be better at recruiting top talent and mitigating future staffing shortages. Forward-looking companies and fund managers are already obtaining cannabis business loans and ramping up HR preparations and organizational structuring to get a jumpstart on the pace of change.

October 15, 2019

Massachusetts Implements Responsible Vendor Training Program

By Aaron G. Biros

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According to a press release published earlier this week, the Massachusetts Cannabis Control Commission approved Cannabis Trainers as one of the state’s first vendor training providers. The training program, Sell-SMaRT™ is the world’s first state-approved cannabis vendor training.

Regulations in Massachusetts require all licensed growers, managers and employees that handle cannabis to take a responsible vendor training class through a certified provider by January 1, 2020.

The Sell-SMaRT™ program was originally developed for licensees handling cannabis in Colorado. In 2015, Colorado regulators granted the program the first ever certification for its Responsible Vendor Program in cannabis. Since then, almost 4,000 people have taken the Cannabis Trainers class, which has been customized for six states, including Massachusetts.

Maureen McNamara, founder of Cannabis Trainers, built on two decades of experience in alcohol vendor training before she started the training program for cannabis. “Massachusetts is really setting a new standard with its training requirements,” says McNamara. “We’ve worked hard to customize the Sell-SMaRT™ program for the state’s needs, and we appreciate the Cannabis Control Commission’s recognition of that. We’re excited to help inspire a cannabis workforce in the state that is responsible, compliant and committed to excellence.”

Meg Sanders, CEO of Canna Provisions, a Massachusetts cannabis company, says the program helps her employees learn the rules thoroughly. “Cannabis Trainers trained all of my Colorado employees, and my entire team in Massachusetts as well,” says Sanders. “I know every time Cannabis Trainers meets with my staff, we walk away smarter and better prepared to help our customers.”

October 14, 2019

CBD In The UK: An Unregulated Marketplace

By Marguerite Arnold

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You have to give it to this industry. Everyone wants in. And well, Prohibition is so over.

The problem is, particularly here in Europe, for the most part, this is either the tedious process of educating doctors, creating medical grade product that insurers will pay for, or of course, trials to look forward to in the immediate future.

In other words, decidedly less colorful (or at least in the North American sense) if not at lower volume than other places.

In the meantime, particularly filtered via American and Canadian coverage and industry success stories, the British are succumbing to the green magic any way they can.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Low-THC, CBD products as a result, are flourishing in a way that seems a bit like the “Colorado of Europe.” The early days. When all sorts of strange stories about processing leaked out of the first legalizing state market in the U.S. It is shocking to European eyes, in particular, of late.

“CBD” is, literally, everywhere.

For those with other kinds of experience in the world of cannabis, however, it is both slightly sad and slightly exhilarating. The Brits have the cannabis bug. But they seem a bit lost on where to go next.

What Is The Deal In The UK?

Regulations are weird here. You cannot use the flower of any cannabis flower (including those with under the requisite amount of THC) – also known as hemp. The novel food discussion is lost.

Regardless, there are clearly plans afoot, particularly on the corporate farming level, to begin a transformation of crops to include cannabis sometime soon. And far beyond the farmers, the boys in the city are getting hot under the collar for this kind of green.

London is also turning into (rather predictably) a center of all things cannabis equity.

There are already more specialty funds planning to list on London exchanges than anywhere else in Europe.

But is this all that surprising?

In the midst of Brexit, a failing NHS, and a society at odds with itself like no time since the 1970’s, the British are facing the cannabis revolution with anything but a stiff upper lip.

When it comes to all things cannabinoids, at least on the CBD side, no matter the odd police raid on a health food store or crunchy vegan experiment on land not protected by the rights of an inherited “country pile”, the cannabis horse, certainly of the broadly stroked CBD variety, is out of the barn.

But What Does this Really Mean?

For the moment? As globally financed companies set up in the UK for all kinds of cannabis trials, the CBD market here is taking on an oddly Bulldog twist.

There is more of a cottage industry of all kinds of CBD products unseen elsewhere in Europe (including from the U.S.). Labeling, testing and sourcing are largely a matter of hit or miss. And just like everywhere else, desperate, sick, depressed people (or those who fear becoming that way) are turning to the CBD miracle to fix a range of conditions.

The problem is that a lot of this is pure snake oil.

Yes, high quality, medical grade CBD does work as a stabilizer (just like THC). But not every oil containing some measure of highly diluted (or worse, contaminated) cannabinoid extract, is the panacea that cannabis offers.

Bottom line? The CBD market in the UK is sort of like Swiss Lite. There are medical trials in the offing, but the country is also in the middle of a constitutional crisis. There are many regulations, and of a bit more fundamentally intrinsic kind, on the line right now. Cannabis is in the room. But so is the Irish Border (the largest if not most existential sticking point in the never-ending Brexit negotiations).

Investing In The UK CBD Market

There are investors who are clearly examining the market, and a few big deals so far, but the vast majority of money flowing into the UK is going into its more flexible (if not frothy) equity market. The British, in other words, may be flailing a bit on domestic implementation, but equity funds in London are in touch with global investors on this issue – even if that money then flows back into Europe.

How very British.

October 11, 2019

What Does GMP Mean? And How Is This Different From EU-GMP?

By Marguerite Arnold

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The cannabis industry is on the road to legitimacy, no matter the bumps, globally. No matter what, and no matter what happens next, that is a good thing. Issues like supply chain transparency, privacy, consumer and patient safety, and of course energy and water use have long been in the room just about everywhere.

Cleantech Is Cannatech

The modern cannabis industry was birthed and given significant shape in deserts (Israel, California, Nevada). In California, as of 2014, producers were warned, yet again, that they could not avail themselves of federally overseen aquifers of groundwater. The legitimizing industry trucked in what it needed.

On the medical discussion, in Europe, in particular, such issues are now in the room. All medical cannabis must be grown indoors. No exceptions.

That means low energy, high efficiency production is on the rise, not the wane.

What Does GMP Mean?

The overall regulations and operating procedures that surround this discussion are known as “Good Manufacturing Practices,” or GMPs for short. But like all the best acronyms, what the standards are, who sets them, and where they are equivalent is still a shifting picture.

Further, GMPs, and even more particularly EU-GMPs, are specifically referred to this way to distinguish the medically bound product from other consumer protection regulations that include novel food.

That said, “GMP practices” differ widely from industry to industry. The idea behind them, however is to prevent harm from occurring to the user, including that the end product is free from contamination, and the packaging as well as manufacture has been well documented. Additional requirements include that personnel are properly trained.

And while the practice, at the pointed end of enforcement can get nerdy, detail-oriented and specific, that is precisely the point. That is also why you might catch another variant of this acronym (cGMP – or current GMP guidelines), to denote a world that is changing fast.

Contamination of the supply chain if not the carbon impact of the same, for all food and plant-based pharmaceutical products is a 21st century problem that is exploding on the scene as fast as the planet warms and cannabis legalizes.

What Do GMP Guidelines Include?

These are guidelines, not steps. As a result, from a bird’s eye view, all international and sovereign national GMP standards include a few basic principles no matter how much they may differ in the weeds. Namely:

That manufacturing processes are clean, controlled and processes are verifiable and repeatable. Changes to any and all must also be clearly documented.
Record keeping, accurate accounting (of product and on the financial side) must be kept, including complete batch history through manufacture and distribution to the end user. Audits are a way of life.
Recall procedures must be in effect.
All complaints about products must be examined.

The World Health Organization (WHO) version of GMP is what’s used by pharmaceutical regulators worldwide. The European Union’s EU-GMP standards are seen as roughly equivalent, as are those now practiced in the U.S. by the FDA. That does not mean that confusion does not reign as standards are changing (across Europe, for example, between individual countries, there is still disagreement). However similar GMPs are used in countries including Australia, Canada, Japan, and Singapore. The UK, of course, is slightly different than anyone else but still has regulations that are roughly equivalent and referred to as “The Orange Guide” (in honor of the color of the book’s cover).

You Know It When You See It

Well, not quite. Beyond GMP, there are of course, other classifications for the kind of plant or product being made, manufactured and distributed. And here, along with international treaties about who can trade with whom, also impact this discussion.

It is not correct, however, for example, to claim that what are known as GACP guidelines (good agricultural and collection practices) are equivalent to GMP. Bio, or pesticide free production (in other words) is just one of many steps in meeting much higher standards now in the room for medically bound cannabis.

What Is GMP “Like”?

All industries have “best practices.” For example, the building industry has all sorts of codes and guidelines. However, in addition to this, about a decade ago, LEED (or green building) certification began to be implemented widely. In the U.S., in particular, there was much discussion about how honest such certifications actually were. The term “greenwashing” was frequently used to describe practices that were sold as energy efficient, but in the end cost more, environmentally and otherwise, than they should.

Like LEED, GMP is not a prescribed set of steps but rather best practice guidelines and regulations meant to guide industries on producing safe products – from seed to sale.

How Does This Differ From WHO Guidelines on GACP for Medicinal Plants?

The World Health Organization’s GACP guidelines are highly controversial in this context, especially when it comes to cannabis. Especially because they refer specifically to plants used as medicine that are “grown in the wild.” I.e. not greenhouse. How these guidelines are interpreted by different countries, however, within the context of the interpretation of “medical cannabis” not to mention pharmaceutical GMPs, are very different.

GACP guidelines, in other words, are sometimes the first step in qualification – but certification under the same (starting with outdoor grown crops produced without pesticides for example) is not likely to pass European medical standards any time soon.

October 10, 2019

Integrated Labeling Helps This Ohio Cannabis Company Grow

By Mike Barker

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Since medical cannabis was legalized in Ohio in 2016, companies that cultivate and process medical cannabis, as well as the plants themselves, have been popping up around the state.

Grow Ohio, a dual-licensed Level 1 cultivator and processor, was the first licensed processor in Ohio and the first to successfully bring product to market. From plant material to edibles, tinctures, oils, lotions and capsules, the company seeks to ensure that medical cannabis is cultivated and processed under the same strict standards as any pharmaceutical medication. As first to market, Grow Ohio found themselves navigating a complicated process by themselves.

As their first product was ready to be packaged, Executive Vice President (EVP) Justin Hunt and the team at Grow Ohio were focused on marketing, packaging and distributing their product. With the sheer number of items that required attention, it is easy to see how something like labelling can slip under the radar. With a variety of products and dosages, and the first delivery of the product slated for late April of 2019, Grow Ohio needed a consistent way to ensure their product complied with state law, and also satisfied their own brand standards.

As their April product launch date grew closer, Grow Ohio realized they needed help with executing on Ohio’s labeling requirements for medical cannabis products.

They turned to Adaptive Data Inc., a barcode and labeling systems supplier to provide labels, printers, and software. ADI’s task was to specify the right label materials for their branding and compliance needs and provide software and equipment to print compliance labels on demand. ADI’s proposed solution would slash the waste associated with printing and applying labels and create a lean process.

Compliance

Compliance labels must contain specific information and must be prominently visible and clearly legible. Containers have to be labeled with details including the specific quantity of product, dosage, THC levels, license #, testing lab name and ID #, and other details. Different sizes and shapes are required for the various packaging form factors.

Due to the large amount of content and a relatively small label area, ADI specified 300 dpi printer resolution so that 4 or 5 point fonts would be legible.

Hunt had all the information needed to comply with state regulations, but didn’t have a way to get that information, properly formatted, onto a finished label at the point of packaging. “It’s all about how you get the data from one source to the other in a way that is easily repeatable,” says Hunt. The solution provides the capability to handle all compliance requirements, for all types of product and all sizes/shapes of labels. The system is designed to minimize key entry of data, a typical source of content errors. All of Grow Ohio’s products contain THC and require the red THC compliance logo. Early on this requirement was met using a separate, hand-applied THC logo label, which was very costly. The labels now include the THC logo, all required compliance data, and the capability to include a 2d barcode.

At the time the products are packaged all compliance information is printed on demand with label printers. As retail expansion continues, the barcode on the plant material compliance label can be used with the POS systems of the dispensaries, to keep their systems fast and accurate.

Until the system is ready to receive data automatically from METRC, the State approved inventory system which tracks all medical cannabis plants and products grown or produced in Ohio, they used user interfaces that reduce the amount of data that is key entered to an absolute minimum. Using drop down lists, date pickers and calculated results, means that Grow Ohio only enters data in 5-10 fields, depending on product line. As the system evolves the next step will be to take data for compliance details automatically from METRC.

Branding

As the first to enter the medical marijuana market, Grow Ohio leadership knew that their brand image is as important to their success as the quality of their products. Their logo, color choice, and inclusion of the THC logo had to be consistent in appearance across all products, regardless of production method. They used full color branded product labels and blank labels that have the Grow Ohio and THC logo pre-printed. (Compliance data is added to the blank labels on demand.)

Label Application – Automatic, Semi-automatic and Manual

Grow Ohio packages in metal cans, glass bottles and in boxes. Each packaging type has specific requirements.

Metal Cans: Grow Ohio uses an automated packaging line for plant material in cans. That line includes two automatic apply-only machines (for brand labels). The compliance label is printed and dispensed and placed on the can as it is boxed.

Bottles: Cylindrical containers can be difficult to label. Grow Ohio originally packaged tinctures and oils in glass bottles which were pre-printed with their logo. The printed logo looked nice, but printing on the glass was expensive. This made placing the compliance label on the bottle more difficult, since the logo could not be covered. Positioning and straightness was critical for readability as well as aesthetics. Manual placement was time consuming (15 – 30 seconds per bottle).

Now, bottles are being processed with the help of a semi-automatic print-apply machine. The print-apply machine can label 18-20 bottles per minute.

By using plain bottles and pre-printing the blue Grow Ohio logo and red THC logo on the label, they were able to streamline the process. The semi-automatic print-apply machine adds the compliance data to the label and applies the label to the bottle.

The result is a lower total cost of the product. Plain bottles cost less without the logo and the labor to manually apply the labels has been greatly reduced. In addition, with the logos on the label instead of the bottle, orientation and spacing are no longer an issue. The label maintains the natural brand feel, which was important to Hunt.

Boxes: Only compliance labels are required for boxes as the branding information is pre-printed on the box. Compliance labels for boxes include a pre-printed, red THC logo. The printer prints the compliance data and presents the label with the liner removed, ready to be manually applied to the box.

Summary

With a broad product line, Grow Ohio’s label requirements are quite diverse. By specifying and sourcing the right hardware, software and label materials,

Adaptative Data provided an efficient, repeatable, cost-effective way to do brand and compliance labeling for Grow Ohio’s diverse product offering.

Hunt now understands the magnitude of work that goes into coming up with a compliant, cost-friendly compliance labeling approach – an appreciation he did not have at the outset. He is not alone in this regard as many companies come to this understanding late in the start-up process.

Hunt isn’t sure how fast the market will grow, but he is not worried. As the market expands and demand grows, he knows his systems can handle it.