Tag Archives: Testing

From MedTech to Cannabis: A Q&A with Jennifer Raeder-Devens

By Aaron G. Biros
No Comments

Project Yosemite, a cannabis product innovation and brand development company, announced earlier this month the appointment of Jennifer Raeder-Devens as their new Chief Scientific Officer. Raeder-Devens is a veteran of the MedTech industry, working for companies like Becton Dickinson, Cardinal Health, Medtronic and 3M.

Prior to joining Yosemite, she was the Vice President of Research & Development at Becton, Dickinson, where she oversaw product development and technology strategies to launch infection prevention products including the ChloraPrep first-in-the-US sterile solution patient preoperative topical antiseptic. She was previously the Vice President of R&D, Strategy and Innovation at Cardinal Health. She’s also held roles at Medtronic, 3M Drug Delivery Systems and 3M Skin Health Division and she has a number of patents in drug delivery and medical devices.

Jennifer Raeder-Devens, Chief Scientific Officer at Project Yosemite

In November of 2018, Project Yosemite launched their first product, OLO, which is an infused, controlled-release sublingual strip. Part of Raeder-Devens’ new role at the company is the continued development and expansion of the OLO sublingual strip technology platform. Andrew Mack, CEO and founder of Project Yosemite, says he’s thrilled to have Raeder-Devens on the team. “Jennifer is an extremely accomplished scientist and engineer with extensive experience driving innovation and R&D in the pharmaceutical and medical device industries,” says Mack.

We caught up with Jennifer over the phone to talk about her background in the MedTech space, why she decided to jump ship to join the cannabis industry and what she’s excited to work on now.

Cannabis Industry Journal: Can you tell us about your background, including your work with 3M and Medtronic? 

Jennifer Raeder-Devens: I’m coming directly from Becton Dickinson, a global med tech company, where I supervised the development of drug-device combination products for topical antiseptics. I spent about 10 years there, mostly in topical drug and combination product development. Prior to that, I was at 3M and Medtronic working in drug-device combination products. At 3M, I was supervising a team of technology developers for the 3M Drug Delivery Systems business. I had experience working with designing and manufacturing transdermal, nasal, buccal and inhalation drug delivery mechanisms for pharmaceutical partners.

I worked on implantable drug delivery systems at Medtronic, which included working on the biocompatibility of things like pacemakers and drug infusion pumps and optimizing them to reduce infection and enhance healing after the implantation procedure.

CIJ: What made you consider joining the cannabis industry? 

Jennifer: With my work in topicals, transdermal and inhalation drug delivery, I had an easy understanding of the different routes of administration we see today in the cannabis industry. And so, from the technology standpoint, I thought this was a place I could contribute to immediately. And then what got me really excited about it was thinking about cannabis, and just like any other drug, with oral drug delivery, you’ve got first class metabolism and side effects from the 11-Hydroxy-THC that are undesirable and you’d rather not have delivered through the gut.

OLO sublingual strips have a 10-minute onset time

I got excited when I saw the development of things like sublingual strips that were focusing on alternatives to smoking that would preserve that relatively fast onset and mitigate some of the side effects of edibles.

The other thing I really like about the cannabis industry: Previously I have been very focused on known drugs that are already approved and repurposing them into a new delivery system. What really interests me about the cannabis industry is the active cannabinoids and terpenes are somewhat known and somewhat unknown, so there is this really interesting challenge there of trying to separate the wheat from the chaff in terms of producing therapeutic effects.

It is a really interesting space where the indications of certain molecules are evolving along with the delivery technology. So, it is a really exciting and eye-opening way to take the next step in my career and have this wide-open space in front of me, both in terms of the different cannabinoids, their effects and the delivery systems we can use.

CIJ: How might you be prepared, given your background, for some of the challenges in the cannabis space?

Jennifer: I think the challenges in cannabis delivery are not different from the challenges in pharmaceutical drug delivery. It’s just that we have this additional complexity of the entourage effect. We can be engineering not just the main ingredient of THC, but also all the other cannabinoids and terpenes. So, for example, with my background in infection prevention, we build a product that we know reduces the risk of infection, but we are really challenged to actually prove it reduces the risk of infection. We have a similar situation in the cannabis industry, where we can get the THC, or CBG or CBN where we want it to go, but then we are really challenged to figure out how we can find, what we call in the pharmaceutical industry, a surrogate end point for efficacy, so that we can test that product and really believe that when we put the product on the market, even though we haven’t tested thousands of users or conducted large randomized clinical trials, that the effect will be shown. We are networking and partnering with a good scientific community to build the right product and do some testing at a small scale that really demonstrates the product achieves the effect that we are really looking for.

CIJ: Can you tell us a little about your new role with Project Yosemite?

Jennifer: My job description falls into three buckets: The first part is that we are forming a scientific advisory board and we are working with some of the leading cannabinoid researchers around the country and around the world. These are the people identifying whether or not certain cannabinoids could reduce cancer cell metabolism or whether cannabinoids contribute to weight loss or diabetes control and other things of that nature. We are trying to reach as far upstream as we can to grasp the emerging understanding of the performance of cannabinoids and terpenes in the endocannabinoid system. So, part of my job is to chair that scientific advisory board, get the thought leaders together in the room and have them bring their knowledge and explore with our own knowledge what cannabis can really do.

The OLO sublingual strips

I have worked in topical, transdermal, buccal, nasal, inhalation drug delivery. In the second bucket of my job, we are trying to understand a given indication or experience that our users want to have, what would be the right route for them. We are challenging our sublingual delivery mechanism to see how fast of an onset we can really get. Right now, we are at 10 minutes for drug delivery in sublingual and we are still trying to get an even faster onset time for the sublingual strip.

For other indications, like chronic pain, we may want to think about a sustained release, so sort of aligning the different indications with which different cannabinoids and terpenes will work for it and see which delivery platform will work for what we are trying to accomplish in each indication.  So, we do not plan to remain solely a sublingual strip company, but will build out additional delivery platforms as we develop new indications.

Right now, we are working upstream with the growers and the processors to get cannabis oil and extracts. Some of the growers are working on different genetics in their cultivars to grow plants that have different ratios of different cannabinoids that we know from the emerging research will have an impact on people’s experience. Now we are working with growers to really get ahead of the curve on how to formulate products with various cannabinoids.

We have an R&D team in house that I supervise. We are always working with our production team to make small improvements such as the faster onset and the dissolution rate and things like flavors, which covers a downstream focus as well.

Aphria, Inc. Implements Quality Management Systems

By Cannabis Industry Journal Staff
1 Comment

According to a press release published today, Aphria Inc. has implemented Rootstock Software’s cloud Enterprise Resource Planning (ERP) solutions and ComplianceQuest’s Enterprise Quality Management System (EQMS). Aphria, one of the largest cannabis companies in the world, trades on both the Toronto Stock Exchange and the New York Stock Exchange.

Rootstock’s cloud ERP software includes things like order processing, production management, supply chain management, lot and serial number trackability and traceability, compliance reporting, costing and financial management. ComplianceQuest’s EQMS software provides support for GMP compliance and can help improve efficiencies in operations. The EQMS focuses on quality and risk management across Aphria’s business platforms, from sourcing to manufacturing to supply chain management.

Aphria is using the entire EQMS platform, which includes software to handle documents, training, changes, inspections, nonconformance, corrective actions (CAPA) and customer complaints which integrates to Rootstock’s ERP. According to the press release, the company is currently working to roll-out audit, equipment, incident and supplier management functions and will be fully live with the entire quality system in the next few months.

According to Tim Purdie, chief information officer & chief information security officer of Aphria Inc., both platforms delivered on their implementation. “Grounded in the scalability of the force.com platform, CQ transformed our quality management operating capabilities overnight and we are delighted at the fully integrated partnership result,” says Purdie. “We now have fully digital real-time informatics and ability to implement change in a highly transparent manner to meet the demands of our high growth business.”

Adding that Rootstock ERP will help facilitate their company’s production, inventory and supply chain management, Purdie says both platforms will enable Aphria to be increasingly responsive to market needs. “Aphria is setting the standard as a worldwide leader in the cannabis industry through a diversified approach to innovation, corporate citizenship, strategic partnerships and global expansion,” Purdie says. “With these system implementations, we’re now technologically equipped to take our competitive advantage to new levels of market leadership.”

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

By Aaron G. Biros
No Comments

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 19th 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 21st 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.

The PathogenDx Microarray

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:

  1. Take 1 gram of cannabis flower or non-flower sample. Or take environmental swab
  2. Drop sample in solution. Swab should already be in solution
  3. Vortex
  4. Transfer 1ml of solution into 1.5ml tube

    A look at how the sample is added to the microarray
  5. Conduct two 3-minute centrifugation steps to separate leaf material, free-floating DNA and create a small pellet with live cells
  6. Conduct cell lysis by adding digestion buffer to sample on heat blocks for 1 hour
  7. Conduct Loci enhancement PCR of sample for 1 hour
  8. Conduct Labelling PCR which essentially attaches a fluorescent tag on the analyte DNA for 1 hour
  9. Pipette into the Multiplex microarray well where hybridization of sample to probes for 30 minutes
  10. Conduct wash cycle for 15 minutes
  11. Dry and image the slide in imager
  12. 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.

A Year In Review: Canadian Recreational Reform Year 1

By Marguerite Arnold
No Comments

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.

GMPDomestic 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.

3 Essential Components of Microbial Safety Testing

By Heather Ebling
1 Comment

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.

Figure 3: The team spiked a known amount of live E. coli into three different environments

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.

A Second Chance: CannTrust To Destroy Inventory & Plants

By Marguerite Arnold
No Comments

The beleaguered CannTrust has been given a way out of the perilous mess that executive management created for the company – but such a salvation comes at a high cost. That said, the company was already in deep water with regulators and clients. Health Canada, in fact, cancelled the company’s license to produce and sell cannabis in September – essentially mandating mass returns two months after a whistleblower instigated what is probably the legal industry’s most egregious scandal to date.

Efforts to regain regulatory approval also include plans by the company to recover cannabis that was not authorized by its license, and improve inventory tracking – the full details of which will be delivered to Health Canada by October 21.

While the beleaguered pot company’s stock predictably surged again on the public markets, the question lingers: can CannTrust ever be trusted again? These were egregious violations.

A Changing Industry

As with most things in business, the issues plaguing CannTrust were not isolated to one company. This has ranged in the past from pesticide use to creative accounting. Not to mention all sorts of creative endeavors on the financial side that are, depending on which stock market you look at this from, less than legit or just this side of shady.

It was easy to throw the book at a company like this – not only for these specific violations, but also as a warning to others tempted to engage in similar tactics (or fail to clean those up that still exist).

CannTrust in other words, was a clarion bell about the change in the weather, driven not only by international treaties but the legitimization of the drug, on the ground. Globally. When large health insurers get involved (see Europe), the conversation begins to change. And it is, fairly drastically.

On the ground in Germany, there are two more cultivation sites underway with one now certified and functional. BfArM (the German equivalent of the FDA) is now on the front lines of a battle that so far, at least in Canada, has not been addressed at a level Europe requires. That said, this reality too is changing. One of the largest distributors in Germany, CC Pharma, now owned by Aphria, has started a supply chain compliance check that is overdue. And further, while focussed on the cannabis industry, in truth, is a problem that plagues pharma far from cannabinoids.

However, as this is the cannabis industry, the scandals that rip through headlines are that much more visceral.

Seed to sale traceability, and further in a model unseen in the industry so far, will also become a watchword that is still rippling through an international industry chafing at any sort of standards, let alone standardization required for pharmaceutical acceptance. The bar, in other words, has just been set much higher. And there are many who will not make the grade.

CannTrust, certainly, was a victim not only of internal mismanagement, but a shifting environment that is rapidly upgrading on a level not seen so far in the entire North American industry – with a few notable exceptions. 

Pharmaceutical Grade Is The Standard To Beat

Here is the reality now facing an industry coming into its own and on an international basis. The standards are tightening. The rules are not only being written but being enforced. And while there are sure to be a few more scandals along the way, the kinds of basic problems found at CannTrust are probably, finally, going extinct in the part of the industry that now knows it is being held accountable to far higher standards.

The reason? Medical grade and national food standards are in the room for every exporter now eyeing Europe. And that alone is resetting the debate everywhere. No matter how treacherous the path may be.

So no matter how harsh the penalties are now facing one company, even the regulators know that this is shifting territory. CannTrust, after all, is being given a second chance.

european union states

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

By Marguerite Arnold
No Comments
european union states

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…

GMPIn 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.

european union statesWalking 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.

The Best Way to Remediate Moldy Cannabis is No Remediation at All

By Ingo Mueller
3 Comments

Consumers are largely unaware that most commercial cannabis grown today undergoes some form of decontamination to treat the industry’s growing problem of mold, yeast and other microbial pathogens. As more cannabis brands fail regulatory testing for contaminants, businesses are increasingly turning to radiation, ozone gas, hydrogen peroxide or other damaging remediation methods to ensure compliance and avoid product recalls. It has made cannabis cultivation and extraction more challenging and more expensive than ever, not to mention inflaming the industry’s ongoing supply problem.

The problem is only going to get worse as states like Nevada and California are beginning to implement more regulations including even tougher microbial contamination limits. The technological and economic burdens are becoming too much for some cultivators, driving some of them out of business. It’s also putting an even greater strain on them to meet product demand.

It’s critical that the industry establishes new product standards to reassure consumers that the cannabis products they buy are safe. But it is even more critical that the industry look beyond traditional agricultural remediation methods to solve the microbial problems.

Compounding Risks

Mold and other microbial pathogens are found everywhere in the environment, including the air, food and water that people consume. While there is no consensus yet on the health consequences of consuming these contaminants through cannabis, risks are certainly emerging. According to a 2015 study by the Cannabis Safety Institutei, molds are generally harmless in the environment, but some may present a health threat when inhaled, particularly to immunocompromised individuals. Mycotoxins resulting from molds such as Aspergillus can cause illnesses such as allergic bronchopulmonary aspergillosis. Even when killed with treatment, the dead pathogens could trigger allergies or asthma.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

There is an abundance of pathogens that can affect cannabis cultivation, but the most common types are Botrytis (bud rot, sometimes called gray mold) and Powdery Mildew. They are also among the most devastating blights to cannabis crops. Numerous chemical controls are available to help prevent or stem an outbreak, ranging from fungicides and horticultural oils to bicarbonates and biological controls. While these controls may save an otherwise doomed crop, they introduce their own potential health risks through the overexposure and consumption of chemical residues.

The issue is further compounded by the fact that the states in which cannabis is legal can’t agree on which microbial pathogens to test for, nor how to test. Colorado, for instance, requires only three pathogen tests (for salmonella, E. coli, and mycotoxins from mold), while Massachusetts has exceedingly strict testing regulations for clean products. Massachusetts-based testing lab, ProVerde Laboratories, reports that approximately 30% of the cannabis flowers it tests have some kind of mold or yeast contamination.

If a cannabis product fails required microbial testing and can’t be remedied in a compliant way, the grower will inevitably experience a severe – and potentially crippling – financial hit to a lost crop. Willow Industries, a microbial remediation company, says that cannabis microbial contamination is projected to be a $3 billion problem by 2020ii.

Remediation Falls Short
With the financial stakes so high, the cannabis industry has taken cues from the food industry and adopted a variety of ways to remediate cannabis harvests contaminated with pathogens. Ketch DeGabrielle of Qloris Consulting spent two years studying cannabis microbial remediation methods and summarized their pros and consiii.

He found that some common sterilization approaches like autoclaves, steam and dry heat are impractical for cannabis due the decarboxylation and harsh damage they inflict on the product. Some growers spray or immerse cannabis flowers in hydrogen peroxide, but the resulting moisture can actually cause more spores to germinate, while the chemical reduces the terpene content in the flowers.

Powdery mildew starts with white/grey spots seen on the upper leaves surface

The more favored, technologically advanced remediation approaches include ozone or similar gas treatment, which is relatively inexpensive and treats the entire plant. However, it’s difficult to gas products on a large scale, and gas results in terpene loss. Microwaves can kill pathogens effectively through cellular rupture, but can burn the product. Ionizing radiation kills microbial life by destroying their DNA, but the process can create carcinogenic chemical compounds and harmful free radicals. Radio frequency (which DeGabrielle considers the best method) effectively kills yeast and mold by oscillating the water in them, but it can result in moisture and terpene loss.

The bottom line: no remediation method is perfect. Prevention of microbial contamination is a better approach. But all three conventional approaches to cannabis cultivation – outdoors, greenhouses and indoor grow operations – make it extremely difficult to control contamination. Mold spores can easily gain a foothold both indoors and out through air, water, food and human contact, quickly spreading into an epidemic.

The industry needs to establish new quality standards for product purity and employ new growing practices to meet them. Advanced technologies can help create near perfect growing ecosystems and microclimates for growing cannabis free of mold contamination. Internet of Things sensors combined with AI-driven robotics and automation can dramatically reduce human intervention in the growing process, along with human-induced contamination. Natural sunlight supplemented with new lighting technologies that provide near full-light and UV spectrum can stimulate robust growth more resistant to disease. Computational fluid dynamic models can help growers achieve optimal temperature, humidity, velocity, filtration and sanitation of air flow. And tissue culture micropropagation of plant stock can eliminate virus and pathogen threats, to name just a few of the latest innovations.

Growing legal cannabis today is a risky business that can cost growers millions of dollars if pathogens contaminate a crop. Remediation methods to remove microbial contamination may work to varying degrees, but they introduce another set of problems that can impact consumer health and comprise product quality.

References

i. Holmes M, Vyas JM, Steinbach W, McPartland J. 2015. Microbiological Safety Testing of Cannabis. Cannabis Safety Institute. http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/Microbiological-Safety-Testing-of-Cannabis.pdf

ii. Jill Ellsworth, June 2019, Eliminating Microbials in Marijuana, Willow Industries, https://willowindustries.com/eliminating-microbials-in-marijuana/#

iii. Ketch DeGabrielle, April 2018, Largest U.S. Cannabis Farm Shares Two Years of Mold Remediation Research, Analytical Cannabis, https://www.analyticalcannabis.com/articles/largest-us-cannabis-farm-shares-two-years-of-mold-remediation-research-299842

 

Steven Burton

A Regulatory Tsunami is Washing Over the Canadian Cannabis Industry

By Steven Burton
No Comments
Steven Burton

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.

GMPMany 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.

HACCPThose 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.

Soapbox

Searching for the Good Stuff

By Cindy Rice
1 Comment

Someone approached me the other day, wanting to know what was the real story about hemp and CBD.

He said he had “a guy” who gave him a CBD salve as part of a study, supposedly “the good stuff,” to help his knee. He couldn’t understand why he was the only one out of 20 people in the group that felt no relief. He happened to have this CBD salve with him, along with a second brand that he hadn’t yet tried. The “good stuff” had slick, colorful packaging, a beautiful logo and powerful marketing messages about the phytocannabinoids and essential oils in the jar. The other CBD product was in a dull grey tin, an ugly duckling, and not nearly so impressive on the outside- I’ll call it “Homer’s Brew.” My friend dismissed Homer’s Brew outright, as not even worth trying. I told him that not all CBD products are created equal, that you can’t always believe the claims on the package, including the cannabinoid potency displayed on the label.

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

I told him to search for the Certificate of Analysis (COA) for each of the two products, specifically, lab test results validating the CBD dosage per serving, and also the breakdown of pesticides, heavy metals and microbials. He had to do a little digging and emailing, as it wasn’t readily available for either company, but the next day, results were in. The “good stuff” with the slick packaging and bold claims had mere trace amounts of CBD, with some hemp and essential oils- no tests for pesticides or contaminants of any kind. Hmmm, no wonder he was disappointed. Homer’s Brew’s COA came in with flying colors – a reputable lab had confirmed safe levels of pesticides, pathogens and heavy metals, and the CBD level was substantial, with a detailed cannabinoid breakdown in the lab report.

In spite of the varying legality of hemp-derived CBD products from one state to the next, consumers are gobbling up costly CBD salves, tinctures and edibles in markets, gyms and online. Like moths to a flame, they are pulled in by the CBD name and lofty promises, not always understanding what they are getting for their money. They trust that these products are safe, licensed, inspected and regulated by some agency, otherwise, “they wouldn’t be on the shelves, would they?”

FDAlogoIn spite of the 2018 Farm Bill, FDA still has not recognized the legality of products containing hemp-derived CBD, but some states have gone ahead and given them a green light anyway- check with your own jurisdiction to be sure. In the meantime, hemp-derived CBD products are slipping through the regulatory cracks, depending on the state. It is confusing, for sure, and buyer beware.

Separate yourself from the pack of snake-oil salesmen. Test your products for safety and accurate cannabinoid potency, and make a Certificate of Analysis readily available to your customers. Boldly portray your transparency and belief in the quality of your products through this COA.

Providing this information to consumers is the best path to success- safe, satisfied customers who will refer to their friends and family, and most likely come back for more of your “good stuff.”