Using Cloud-Based LIMS To Improve Efficiency In Cannabis Labs

By Shonali Paul
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Cannabis testing laboratories around the country are expanding quickly, taking on new clients and growing their business incrementally. Many of these labs are receiving a large number of test requests from growers for potency testing, terpene profiling, pesticide screening, residual solvent screening, heavy metal testing, microbial analysis and even genetic testing. To keep pace with the number of test requests received, efficient data, sample and test management is imperative.

Considering the magnitude of cannabis testing, data management using spreadsheets is a serious impediment to quality assurance. Data being recorded in spreadsheets is error-prone and difficult to manage. Furthermore, using spreadsheets does not allow labs to adhere to regulatory guidelines that demand strict accounting for every gram of the sample, right from reception, consumption for testing, to disposal.

Log samples, keep track of Chain of Custody(CoC), track samples from initial location in the lab through disposal by recording location, custodians and other metadata

To overcome such data management challenges and improve the operational efficiency of cannabis testing laboratories, a Laboratory Information Management System (LIMS) plays a significant role. LIMS are much more capable than spreadsheets and paper-based tools for managing analytical and operational activities. LIMS enhances the productivity and quality by eliminating the manual data entry. With its built-in audit trail capability, LIMS helps labs adhere to regulatory standards.

LIMS can provide companies with a method to manage samples, records and test results, and ensures regulatory compliance by increasing traceability. LIMS can also be integrated with other lab instrumentation and enterprise systems, enabling easier transmission of information across the lab and the organization, reducing manual efforts and improving decision-making.

Account for the entire quantity of sample received, used and disposed

Multiple resources are also available to assist labs in preparing for quality assurance and accreditation, LIMS being one of them. LIMS can help cannabis labs with instrument integration, and automate reporting to help improve efficiencies and reduce errors. LIMS, such as CloudLIMS Lite, a cloud-based LIMS, automates cannabis-testing workflows right from sample collection, data recording, managing test chain of custody, sample weight accounting to report generation. With data security and audit trails, a LIMS provides traceable documentary evidence required to achieve ISO 17025 accreditation for highly regulated labs. Above all, cloud-enabled systems are often low in the total cost of acquisition, have maintenance outsourced, and are scalable to help meet the ever-changing business and regulatory compliance needs.

Incorporate all tests, instruments, sample information and result data (etc.) in one place

Cloud-based products are secure, easy to deploy and scalable. A cloud product is typically hosted on a server with a guaranteed uptime of 99.5%, allowing for a reliable system, accessible 24×7. Cloud-based LIMS have automatic data backup mechanism that allow for quick turnarounds in case of a server failure or in the eventuality of a natural disaster.

With LIMS in place, cannabis labs can manage sample and requisition-centric records, track sample quantity and location, integrate the test data, and provide online reports to clients. This in turn, reduces the turnaround time for testing and improves the operational efficiency. Besides, audit trail of each and every activity performed by the lab personnel is recorded in the system to ensure that the lab follows regulatory compliance.

Editor’s Note: This is a condensed version of a poster that was submitted and displayed at this year’s Cannabis Science Conference in Portland, Oregon. The authors of the original poster are Arun Apte, Stephen Goldman, Aditi Gade and Shonali Paul.

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 3

By Aaron G. Biros
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In the first part of this series, we spoke with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics of cannabis laboratory accreditation. In the second part, we sat down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

In the third part of this series, we sit down with Michael DeGregorio, chief executive officer of Konocti Analytics, Inc., to talk method development in the cannabis testing industry and his experience with getting accredited. In the final part of this series, we are going to sit down with Susan Audino, an instructor at A2LA to learn more about the requirements where she’ll offer some advice for labs seeking accreditation.

Michael DeGregorio, chief executive officer of Konocti Analytics, Inc.

Michael DeGregorio is a doctor of pharmacy with an extensive career in medicine and scientific research. He’s worked in cancer research and medicine, teaching at the University of California, San Francisco, Yale University School of Medicine, University of Texas, Health Science Center at San Antonio and University of California, Davis. Before becoming the CEO of Konocti Analytics, a laboratory based in California, DeGregorio was also a published author in a large number of peer-reviewed medical journals.

In this piece, we sit down with DeGregorio to find out what challenges labs face when getting accredited, why they sought accreditation and their experience with getting off the ground. Stay tuned for the final part of this series!

CannabisIndustryJournal: How does a laboratory go about choosing an appropriate method in an industry where, generally, there are no validated methods available?

Michael DeGregorio: Our approach to developing analytical methods for testing cannabis began with a review of the existing laboratories and their methods, where we found no standardization and inconsistent results. Since cannabis is being used by the public and as a medicine, our goal is to help make it as contaminant-free as possible for the well-being of the consumer, and this begins by developing a state-of-the-art analytical facility.

When developing new methods, we review the published literature to see what has already been done and try to arrive at a scientifically sound consensus. We then perform experiments to determine which set of conditions works best for us. Once we have developed an appropriate method, we validate it pursuant to ISO/IEC 17025 requirements.

CIJ: How do you go about choosing what type of equipment to use for testing (e.g. by limit of detection, acceptable method use of equipment for other industries, etc.)?

Michael: After reviewing the operations of other testing laboratories, we concluded that, in general, they were not taking advantage of the most advanced technologies and had limited personnel qualified to operate it. Because public safety is our main concern, we chose state-of-the-art equipment, including GC/LC-MS with Orbitrap and ICP-MS, for testing medicinal cannabis. In addition to identifying unknown pesticides, we needed the capability of performing full chemical screening of all samples for potentially harmful compounds, e.g. steroids, present in cannabis, as well as the ability to detect trace levels of metals.

Our greatest concern is the fact that pesticides in cannabis have not been adequately studied. Current pesticide regulations suggest that government authorities believe that there are a finite number of pesticides available. Smart farmers could easily avoid the pesticides on current lists. Because of this, we chose to validate our pesticide methods with a focus on chemical classes, as opposed to specific pesticides, to give us the broadest possible coverage of potential compounds. The Orbitrap mass spectrometers also allow us to detect and identify unknown pesticides. This is something not currently being done by other laboratories. The latest microbiology methods for cannabis testing include DNA analysis, and for this we use qRT-PCR technology. Finally, the high sensitivity of ICP-MS allows for the detection of metals concentrations that may be harmful, yet undetectable by other means.

CIJ: What do you feel are the benefits of being accredited?

Michael: Being accredited shows the public that we have made a commitment to quality analytics. We feel this gives our clients peace of mind when marketing their products, knowing that they have been tested by a laboratory meeting the highest international standards of operation available using the latest technology. Furthermore, being accredited requires participation in ongoing proficiency testing programs, which helps maintain analytical competency. It should be pointed out that any prospective client of an analytical facility should take into account the laboratory’s full accredited scope of testing to ensure its competency.

CIJ: What challenges did you face during the process of getting your laboratory started and/or during the accreditation process?

Michael: Developing the quality management system and getting our equipment and processes to a state where they met accreditation requirements took several months of hard work, and turned out to be a bit more daunting than we anticipated. Our pre-accreditation assessment revealed that much work remained to be done, and it gave us a real appreciation for the level of detail and documentation required. We remained determined and eventually achieved our accreditation.

CIJ: What are the benefits to the grower and dispensaries to choosing an accredited laboratory for the testing of their product?

Michael: By choosing an accredited laboratory with a full scope of testing (potency, pesticides, mycotoxins, metals, microbiology, residual solvents and terpenes), growers and dispensaries can rest assured that their products have been tested using validated methods with appropriate quality control by trained, competent personnel. For growers, this makes their products more attractive to potential buyers. For dispensaries, this means they can confidently market their products with the knowledge that the information shown on the label is accurate, which in turn gives their customers peace of mind that the product they are consuming does not contain unacceptable levels of contaminants. 

CIJ: Why did you choose A2LA?

Michael: Once we decided to pursue accreditation, we researched the various accrediting bodies available as well as their reputations. We discovered that while all accrediting bodies are themselves accredited to the same standard, accreditation by the various bodies was not considered equal in practice. In our opinion, A2LA was considered the most prestigious, highly regarded accrediting body. Furthermore, some of the most prestigious laboratories in the country are accredited by A2LA, including Los Alamos National Laboratory, the Food and Drug Administration’s Center for Biologics Evaluation and Research, Lawrence Livermore National Laboratory, Centers for Disease Control, Federal Bureau of Investigation and the United States Department of Agriculture. Many of our preferred sources of scientific supplies and services are accredited by A2LA as well. As our goal was to be accredited by the best available accrediting body, we chose A2LA.

What’s Happening on Capitol Hill? Part 4: Banking & Tax Reform

By Brian Blumenfeld, J.D., M.A.
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To round out our federal reform review, we look at the bills introduced into the 115th Congress that attempt to resolve the banking and taxation problems faced by state-legal cannabis businesses. As this is perhaps the biggest thorn in the side of the cannabis industry, any movement by the feds on these issues will be welcomed. As it turns out, there are four proposals currently pending for fixing the broken cannabis financial services system, with each proposal comprising a pair of House-Senate companion bills. We look at each pair in turn.

Group 1

S. 1156 – SAFE Act; or, Secure and Fair Enforcement Banking Act

HR. 2215 – SAFE Act; or, Secure and Fair Enforcement Banking Act

Policy: These SAFE Acts would prohibit federal prosecutors and federal regulators from preventing or disciplining in any way a depository institution simply because that depository institution serviced a cannabis-related business.

Impact: The impact of these bills would be widespread for both the cannabis industry and for financial service institutions looking to capitalize on the cannabis industry. For banks, the bills would remove all of the barrier-risks that are now keeping them out of the cannabis business. Currently, the feds have handed down policy guidance to banks stating that as long as they submit what are called “Suspicious Activity Reports, or “SARs” for cannabis-related accounts, and conduct their due diligence to ensure such accounts are complying with state law, then those banks will not be pursued by federal law enforcement. The problem with this guidance is that it is only policy, it is not law, and so it can change on as little as an administrative whim. The protection from cannabis business risk, most banks have determined, is therefore temporary at best and illusory at worst. Passage of the SAFE Act would instantly change all of that and initiate a banking bonanza. Banks will be racing to profit off of what is amounting to a newly minted billion dollar industry. Cannabis businesses will benefit greatly from all of this. Not only will they be able to stop operating strictly in cash and have access to all the traditional financial services that other businesses heavily rely on, but they will also be the beneficiaries of a highly competitive, and therefore affordable and efficient, cannabis banking market.

Procedural Status:

S. 1156

  • Introduced: May 17, 2017 by Senator Jeff Merkley (D-OR)

    Senator Jeff Merkley (D-OR)
    Image: Medill DC, Flickr
  • Cosponsors: 3 Republicans, 7 Democrats, 1 Independent
  • Referred to Senate Committee on:
    • Banking, Housing, and Urban Affairs

HR. 2215

  • Introduced: April 27, 2017 by Representative Ed Perlmutter (D-CO)
  • Cosponsors: 7 Republicans, 44 Democrats
  • Referred to House Committees on:
    • Judiciary
      • Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
    • Financial Services

Group 2

S777 – Small Business Tax Equity Act of 2017

HR 1810 – Small Business Tax Equity Act of 2017

Policy: These bills would carve out an exception to IRC 280E allowing cannabis businesses to deduct ordinary business expenses from their federally taxable revenues.

Impact: If enacted these bills will dramatically ease the tax burden for cannabis businesses. Currently, even when they are in perfect compliance with state law, cannabis businesses are not permitted to deduct ordinary business expenses. This means that net taxable revenues are, and are going to continue to be, substantially higher than net taxable revenues for businesses in any other industry. If enacted, profit margins—and therefore product quality, operational efficiency and innovation—are going to uptick across all states that have legalized.

Procedural Status:

Senator Ron Wyden (D-OR)
Image: JD Lasica, Flickr

S. 777

  • Introduced: March 30, 2017 by Senator Ron Wyden (D-OR)
  • Cosponsors: 1 Republican, 4 Democrats
  • Referred to Senate Committee on:
    • Finance

HR. 1810

  • Introduced: March 30, 2017 by Representative Carlos Curbelo (R-FL)
  • Cosponsors: 10 Republicans, 24 Democrats
  • Referred to House Committee on:
    • Ways and Means

Group 3

S. 780 – Responsibly Addressing the Marijuana Policy Gap Act of 2017

HR. 1824 – Responsibly Addressing the Marijuana Policy Gap Act of 2017

Policy: These bills combine to accomplish what each of the foregoing pairs accomplish separately. IRC 280E would no longer apply to state-legal cannabis businesses, and banking would become available for them as well. Additionally, advertising prohibitions in the CSA and the Communications act of 1934 would be removed, with the one exception that advertisements inducing travel from a state where cannabis is not legal to a legal cannabis state would be prohibited. Under Title II of the acts, barriers to federal bankruptcy proceedings would be removed. These bills would also reform the CSA as it relates to criminal liability for individuals, criminal record expungement and medical research for institutions, all of which are noteworthy but neither of which directly impact the legal cannabis industry.

Impact: For the impact of IRC reform, see “Impact” section under S.777/HR.180. For the impact of banking reform, see “Impact” section under S.1156/HR/2215.

By leaving advertising guidelines completely up to the states, we would probably witness the easing of advertising restrictions by the states. Currently, states have tight advertising rules because, after protecting consumers, they do not want their state’s legal cannabis industry to draw attention from the feds in any way. That concern would become moot and we could see more advertising in and across legalized states. This would drive competition across larger markets, in terms of both product and service quality and branding/marketing strategy.

Access to federal bankruptcy proceedings would clarify the landscape for all potential financial scenarios in the lifecycle of cannabis businesses, which in turn will ease uncertainty concerns of potential investors. The bankruptcy provision, combined with the banking provisions will undoubtedly open access to capital for cannabis businesses looking to grow operations and market presence.

Procedural Status:

S. 780

  • Introduced: March 30, 2017 by Senator Ron Wyden (D-OR)
  • Cosponsors: None
  • Referred to Senate Committee on:
    • Finance

HR. 1824

Representative Earl Blumenaur (D-OR)
Photo: Bridget Baker, 92bridges.com
  • Introduced: March 30, 2017 by Representative Earl Blumenaur (D-OR)
  • Cosponsors: 0 Republicans, 8 Democrats
  • Referred to House Committees on:
    • Judiciary
      • Crime, Terrorism, Homeland Security, and Investigations
      • Regulatory Reform, Commercial and Antitrust Law
      • Immigration and Border Security
    • Energy & Commerce
      • Health
    • Ways and Means
    • Financial Services
    • Natural Resources
      • Indian, Insular, and Alaskan Affairs
    • Education and the Workforce
    • Veterans’ Affairs
      • Health
    • Oversight and Government Reform

Group 4

S. 776 – Marijuana Revenue and Regulation Act

HR. 1823 – Marijuana Revenue and Regulation Act

Policy: Subchapters A and B of these bills would impose two additional federal tax requirements on cannabis businesses. The first would be an excise tax on all producers, beginning at a rate of 10%, and growing each year that a producer is in business to a cap of 25% at five years. The second tax would be an occupational tax of $1,000 per year, to be paid by the principals of any cannabis producer or warehouse proprietor. Significantly, these bills would also authorize the federal government to regulate operations in the industry.

Impact: The tax impact of these bills would be a straightforward additional tax that cannabis businesses would have to pay, on top of state and local taxes. The burden of additional taxes will inevitably impact profit margins, initial decisions on whether or not to enter the market and strategies for expansion and innovation. The impacts of federal authorization and regulatory requirements was discussed in the second article of the series, specifically under the “Impact” section of HR1841

Procedural Status:

S. 776

  • Introduced: March 30, 2017 by Senator Ron Wyden (D-OR)
  • Cosponsors: None
  • Referred to Senate Committee on:
    • Finance

HR. 1823

  • Introduced: March 30, 2017 by Representative Earl Blumenaur (D-OR)
  • Cosponsors: 0 Republicans, 8 Democrats
  • Referred to House Committee on:
    • Ways and Means

The Catalonian Crisis & Cannabis: The Quick Death Of A Newly Regulated Club Scene?

By Marguerite Arnold
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The politics of pot have always been strange. Everywhere. In the modern age of legalization, the battle lines around reform always seem to find expression in the faults if not flames of other highly divisive issues.

It has certainly been true in the United States. And now that has come to Europe.

Where Are The Spanish Fault Lines?

The recent independence bid of Catalonia, up until now, an “autonomous” region of Spain, has all the hallmarks of the same. Catalonia is, in essence a Spanish state, in the northeast corner of the country along the Mediterranean coast. The region also has, outside of its separatist ambitions, pioneered the cannabis club movement. Barcelona of course is the capital of it all. And since the summer of 2017, the continued legalization of the industry here has caused ripples throughout Europe on the recreational and medical cannabis fronts.

View of Barcelona from the Sagrada Família
Image: Michele Ursino, Flickr

Spanish politics are a bit complicated, but basically since the end of fascist rule in 1977, there are a few states with a little more independence from Madrid than others. Catalonia and Barcelona in particular have since flourished as both the economic powerhouse of the country and, incidentally, canna-club reform. Entrepreneurialism in general is high here.

But the idea of the Basques or Catalonia “succeeding” is about as unlikely as Scottish independence.

Why? Economics.

As a result then, where goes the newly legit cannabis club vertical? Will Madrid put a kibosh on that along with “home rule?”

Holland 2.0?

In many ways, Catalonia’s cannabis industry is the next iteration of Amsterdam’s coffee shops. The only difference has been a membership fee rather than an instant cash transaction at retail point of sale. That said, there are many obvious similarities. The supply chain feeding the clubs with product has up until now, flourished in between the grey lines of the law.

The same arguments for legalization also exist here as they do everywhere else – if not perhaps so colourfully. The Catalonian paella of legalization advocates include those who rely on the drug for medical purposes plus those who believe they should have the right to recreational use. And of course, this also includes the police. The latter of whom, who at one point, were seizing so that plants quickly overtook evidence rooms. Spanish creativity in reconverting existing real estate to undercover crop cultivation has created more crop than cops can track down if left unregulated.

Spanish national police trying to stop the independence vote resulted in violence Image: Gustavo Valiente, Flickr

However, much like the purple passions of Colorado, this discussion about legalization has also always been drawn, if not flamed, by passions that also occur along other fault lines. In the U.S., over the first decade of this century, legalization of marijuana and gay marriage literally split the country in two. Colorado in fact first voted to ban gay marriage before voting for recreational legalization. California was also an early mover in both gay marriage and legalizing medical cannabis.

The Spanish version of this, of course, is the current Catalan bid for greater independence. And this has plunged the country into its worst political crisis since it returned to democratic government after the forty-year-plus rule of the fascist dictator Franco, if not the failed coup in the early 1980’s to re-establish military rule.

It is also not a trivial question to ask what will happen to the cannabis industry that has begun to flourish here if Madrid reimposes direct rule? While the industry that has been legalizing over the past three to four years, this summer, Catalonia moved finally to legalize cannabis cultivation and consumption across the board.

While that may seem to be a stupid if not irrelevant question– at least outside the cannabis industry itself – it may be highly relevant to what comes next.

Flying High On Reform

Catalonia has been the economic engine of the Spanish economy since Franco. In fact, that is one of the reasons that Madrid could never allow the region to split away. Another undeniable reality? The only thing that Catalonia does not have complete control over is its taxation and the redistribution of said funds to the rest of the country (including the equally separatist-inclined Basques just to the north). Not that Catalans really seem to be all that sure about this desire of full independence. In fact, the succession vote itself, much like Brexit, seemed to be more a criticism of politics in Madrid rather than a desire to become fully independent of it.

Demonstrators in Barcelona march for a vote on independence
Image: Joan Campderrós-i-Canas, Flickr

It is also unlikely that the recent cannabis business will go away – no matter what happens with direct rule. Catalonia’s decision to proceed with full legalization was intended to become, much like Colorado turned out to be. A guideline for better clarification on the federal level. If not a blueprint for other regions to follow when it comes to cannabis clubs.

There are very dramatic statements still flying between parties in Madrid and those who seek to stimulate if not agitate for greater independence. But that is unlikely to happen for several reasons beyond internal Spanish politics. European leaders are not encouraging another Brexit. This, to both Emmanuel Macron and Angela Merkel, is an internal, domestic issue. And the locals are still very unsure about the next steps.

Is There A Connection Other Than Timing?

Things are starting to change – and dramatically on many fronts. There are political fault lines everywhere, where marijuana is showing up in strange forms and incarnations. The delay on the German bid is apparently another one.

There is also a clear connection just about everywhere between cannabis reform and the desire for something different . Whatever that might be. Including broader political change.

Demonstrations before the vote for independence
Image: SBA73, Flickr

What does that mean? For the industry specifically? For the market that is developing in Canada, Europe and elsewhere, political and operational risks are some of the equations contributing to the bottom line.

There is also this reality. To date, the real money in the Spanish market is also being made in medical. Or about to be. See the Alcaliber alliance with Spektrum. No matter how attention grabbing the Spanish headlines may be, the larger game moves forward inevitably. As does medical reform, plus greater access even without the cannabis club economy.

Could there be a pot-themed compromise to what troubles the land where the rain falls mainly on the plain? Sure. Givebacks of a financial kind, including for example, the right to keep all pot taxes local, might be solutions that could be tried if there is an attempt to defuse a situation that is tense. And still on an uncertain course.

KIND Financial Launches Canadian Payment Solution

By Aaron G. Biros
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KIND Financial, a technology and compliance software solutions provider in the cannabis industry, is launching a new e-commerce and payment processing platform in Canada. According to the press release, they are partnering with a Canadian bank to launch the KIND Seed to Payment platform, which is essentially an e-commerce gateway integrated with their compliance software, KIND’s RegTech platform.

David Dinenberg, founder and CEO of KIND Financial

David Dinenberg, founder and CEO of KIND Financial, says this is an approach to help alleviate the cannabis industry’s banking woes. “We’ve been very focused on a global vision and taking a strategic approach towards solving the cannabis industry’s largest problem – banking,” says Dinenberg. “Not only have we built a broad portfolio of finance and compliance solutions with a high-level of technical sophistication, but we’ve made a strong commitment to security and compliance, which is evident through our partnership with Microsoft.” A little over a year ago, they entered a partnership with Microsoft to utilize their cloud-based solutions for government traceability software.

According to the press release, the software has regulatory and security features built in, such as age and identity verification, which can help companies comply with security and chain of custody regulations. “Our mission is to ensure business and technological growth for all constituencies within the cannabis industry while ensuring full compliance with evolving regulations, and that’s why we’re thrilled to make these services available to our great neighbors in the north,” says Dinenberg. “We understand compliance will be a critical issue for some time to come, but with our solution, all providers and their partners can focus on the job at hand while keeping in line with regulatory mandates.”

KIND Financial has not done much work in Canada previously, but this could be a sign of a greater push for international expansion. “We’re excited to be working in a new country to boost the Canadian cannabis industry in a safe and regulated manner, and we look forward to expanding into other markets overseas,” says Dinenberg. The press release says the new platform is designed to work with different languages and foreign currencies, including the euro and Australian dollar, which could help Canadian producers enter emerging markets.

In addition to their announcement of the KIND Seed to Payment platform, the company also announced they will be rolling out a mobile payment system called KIND Pay, a digital payment option for consumers that will accept Visa and MasterCard. They anticipate that KIND Pay will launch before the end of this year.

Quality Assurance In The Field: Instruments For Growers & Processors

By Aaron G. Biros
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As the cannabis marketplace evolves, so does the technology. Cultivators are scaling up their production and commercial-scale operations are focusing more on quality. That greater attention to detail is leading growers, extractors and infused product manufacturers to use analytical chemistry as a quality control tool.

Previously, using analytical instrumentation, like mass spectrometry (MS) or gas chromatography (GC), required experience in the laboratory or with chromatography, a degree in chemistry or a deep understanding of analytical chemistry. This leaves the testing component to those that are competent enough and scientifically capable to use these complex instruments, like laboratory personnel, and that is still the case. As recent as less than two years ago, we began seeing instrument manufacturers making marketing claims that their instrument requires no experience in chromatography.

Instrument manufacturers are now competing in a new market: the instrument designed for quality assurance in the field. These instruments are more compact, lighter and easier to use than their counterparts in the lab. While they are no replacement for an accredited laboratory, manufacturers promise these instruments can give growers an accurate estimate for cannabinoid percentages. Let’s take a look at a few of these instruments designed and marketed for quality assurance in the field, specifically for cannabis producers.

Ellutia GC 200 Series

Shamanics, a cannabis extractor in Amsterdam, uses Ellutia’s 200 series for QA testing

Ellutia is an instrument manufacturer from the UK. They design and produce a range of gas chromatographs, GC accessories, software and consumables, most of which are designed for use in a laboratory. Andrew James, marketing director at Ellutia, says their instrument targeting this segment was originally designed for educational purposes. “The GC is compact in size and lightweight in stature with a full range of detectors,” says James. “This means not only is it portable and easy to access but also easy to use, which is why it was initially intended for the education market.”

Andrew James, marketing director at Ellutia

That original design for use in teaching, James says, is why cannabis producers might find it so user-friendly. “It offers equivalent performance to other GC’s meaning we can easily replace other GC’s performing the same analysis, but our customers can benefit from the lower space requirement, reduced energy bills, service costs and initial capital outlay,” says James. “This ensures the lowest possible cost of ownership, decreasing the cost per analysis and increasing profits on every sample analyzed.”

Shamanics, a cannabis oil extraction company based in Amsterdam, uses Ellutia’s 200 series for quality assurance in their products. According to Bart Roelfsema, co-founder of Shamanics, they have experienced a range of improvements in monitoring quality since they started using the 200 series. “It is very liberating to actually see what you are doing,” says Roelfsema. “If you are a grower, a manufacturer or a seller, it is always reassuring to see what you have and prove or improve on your quality.” Although testing isn’t commonplace in the Netherlands quite yet, the consumer demand is rising for tested products. “We also conduct terpene analysis and cannabinoid acid analysis,” says Roelfsema. “This is a very important aspect of the GC as now it is possible to methylate the sample and test for acids; and the 200 Series is very accurate, which is a huge benefit.” Roelfsema says being able to judge quality product and then relay that information to retail is helping them grow their business and stay ahead of the curve.

908 Devices G908 GC-HPMS

908 Devices, headquartered in Boston, is making a big splash in this new market with their modular G908 GC-HPMS. The company says they are “democratizing chemical analysis by way of mass spectrometry,” with their G908 device. That is a bold claim, but rather appropriate, given that MS used to be reserved strictly for the lab environment. According to Graham Shelver, Ph.D., commercial leader for Applied Markets at 908 Devices Inc., their company is making GC-HPMS readily available to users wanting to test cannabis products, who do not need to be trained analytical chemists.

The G908 device.

Shelver says they have made the hardware modular, letting the user service the device themselves. This, accompanied by simplified software, means you don’t need a Ph.D. to use it. “The “analyzer in a box” design philosophy behind the G908 GC-HPMS and the accompanying JetStream software has been to make using the entire system as straightforward as possible so that routine tasks such as mass axis calibration are reduced to simple single actions and sample injection to results reporting becomes a single button software operation,” says Shelver.

He also says while it is designed for use in the field, laboratories also use it to meet higher-than-usual demand. Both RM3 Labs in Colorado, and ProVerde in Massachusetts, use G908. “RM3’s main goal with the G908 is increased throughput and ProVerde has found it useful in adding an orthogonal and very rapid technique (GC-HPMS) to their suite of cannabis testing instruments,” says Shelver.

Orange Photonics LightLab Cannabis Analyzer

Orange Photonics’ LightLab Cannabis Analyzer

Dylan Wilks, a third generation spectroscopist, launched Orange Photonics with his team to produce analytical tools that are easy to use and can make data accessible where it has been historically absent, such as onsite testing within the cannabis space. According to Stephanie McArdle, president of Orange Photonics, the LightLab Cannabis Analyzer is based on the same principles as HPLC technology, combining liquid chromatography with spectroscopy. Unlike an HPLC however, LightLab is rugged, portable and they claim you do not need to be a chemist to use it.

“LightLab was developed to deliver accurate repeatable results for six primary cannabinoids, D9THC, THC-A, CBD, CBD-A, CBG-A and CBN,” says McArdle. “The sample prep is straightforward: Prepare a homogenous, representative sample, place a measured portion in the provided vial, introduce extraction solvent, input the sample into LightLab and eight minutes later you will have your potency information.” She says their goal is to ensure producers can get lab-grade results.

The hard plastic case is a unique feature of this instrument

McArdle also says the device is designed to test a wide range of samples, allowing growers, processors and infused product manufacturers to use it for quality assurance. “Extracts manufacturers use LightLab to limit loss- they accurately value trim purchases on the spot, they test throughout their extraction process including tests on spent material (raffinate) and of course the final product,” says McArdle. “Edibles manufacturers test the potency of their raw ingredients and check batch dosing. Cultivators use LightLab for strain selection, maturation monitoring, harvesting at peak and tinkering.”

Orange Photonics’ instrument also connects to devices via Wi-Fi and Bluetooth. McArdle says cannabis companies throughout the supply chain use it. “We aren’t trying to replace lab testing, but anyone making a cannabis product is shooting in the dark if they don’t have access to real time data about potency,” says McArdle.

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Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 2

By Aaron G. Biros
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roger_headshot

In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.

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Roger Brauninger, A2LA biosafety program manager

He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).

In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.

CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?

Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.

CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?

Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.

CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?

Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to   provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.

CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?

Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.

CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?

Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.

CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?

Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court.   It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 1

By Aaron G. Biros
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Laboratories throughout the world and in a variety of industries get accredited to demonstrate their competency. In the cannabis industry, some states are beginning to require it and many labs get accredited even if their state doesn’t require it. So what does accreditation mean and why is it so important?

The International Organization for Standardization (ISO) is a standard-setting organization that works to promote industrial and commercial standards. The standards set by ISO are designed to help prove a product’s safety and quality to a certain minimum level.

The ISO/IEC 17025:2005 standard sets specific requirements to demonstrate the competence of a lab for carrying out tests. It essentially shows customers or regulators that a lab has the skills and scientific know-how to perform testing, certifying the lab is capable. Accreditation means certifying a lab to that standard and is synonymous with both quality and competence of an organization.

Michelle Bradac, senior accreditation officer at A2LA

The American Association for Laboratory Accreditation (A2LA), founded in 1978, is a non-profit, internationally recognized accreditation body in the United States that offers laboratory and laboratory-related accreditation services and training. They have worked in the cannabis industry to accredit a number of cannabis laboratories to the ISO/IEC 17025:2005 standard. In this series of articles, we sit down with experts from A2LA to learn more about cannabis lab accreditation, why it’s so important and some of the challenges labs face when seeking accreditation.

In the first part of this series, we sit down with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics. Michelle earned a bachelor’s degree in Biology at Towson State University and then attended Hood College, earning a master’s certificate in Regulatory Compliance in Biomedical Science. She has worked at A2LA for eight years, assisting in the accreditation of food testing, environmental testing and cannabis testing laboratories to ISO/IEC 17025, as well as performing quality system assessments. She also facilitates a number of accreditation programs including Field Sampling Measurement Organizations, STAC (Air Emissions) and Cannabis Testing. Bradac is also a member of the ASTM Cannabis Working Group and the ACIL Cannabis Working Group.

In the next part of this series, we will hear about specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories.

CannabisIndustryJournal: What is Laboratory Accreditation? 

Michelle Bradac: Laboratory accreditation is a formal means of determining and recognizing the technical competence of laboratories to perform specific types of testing, via the use of an independent third party accreditation body. It provides laboratory users a mechanism to identify and select reliable testing organizations. Use of ISO/IEC 17025 as a basis for laboratory accreditation is internationally recognized as THE conformity assessment standard to which laboratories are accredited; it is used in the USA by both Public (State, local, federal (FDA, USDA, CDC, DoD and EPA) and private laboratories for testing of foods & feeds, drugs, cosmetics, tobacco, natural products and cannabis (among other materials and products).

CIJ: How does laboratory accreditation benefit the cannabis testing laboratory? 

Michelle: It provides a framework for continuous improvement and self-correction where the cannabis testing laboratory data management system is independently reviewed and blinded sample Proficiency Testing is encouraged.

CIJ: How does laboratory accreditation benefit the medical cannabis recommending physician?

Michelle: The physician gains a greater degree of assurance that the material provided by the dispensary is what the label says it is. This is especially important in working with patients that are immunocompromised where heavy metals, residual solvents and harmful pesticides could have negative health consequences.

CIJ: How does the testing of medical cannabis by an accredited laboratory benefit the patient?

Michelle: The patient gains increased confidence that the label accurately reflects the potency and chemical properties of the product.

CIJ: What specific challenges does A2LA face in accrediting cannabis testing laboratories?

Michelle: Much of the typical infrastructure is lacking or only now being developed. This ranges from proficiency testing programs, Reference Material Producers, method development and sampling procedures. There is also difficulty in ensuring that laboratories are appropriately validating methods in states where cannabis product is not yet available.

CIJ: Why is A2LA the optimal choice for ensuring the quality and reliability of the results produced by medical marijuana testing laboratories?

Michelle: A2LA has by far the most experience as an accreditor of laboratories that perform testing of natural plant products. We have been performing assessments of and granting accreditation to these types of laboratories for over twenty years. This results in our staff and our assessor corps who are then able to provide valuable insight and technical sophistication that other accreditation bodies do not have. Specific to the cannabis industry, A2LA is also represented in all the major standards development organizations, tradeshows and industry groups; which strengthens our understanding of the industry and ability to assist our customers towards meeting their goal of obtaining accreditation.

Digipath Expands To California

By Aaron G. Biros
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In July, we sat down with the folks at Digipath, Inc. when they received their testing license in Nevada for the adult use market. In that conversation, they mentioned they were looking to expand into California.

According to a press release published September 25th, DigiPath, Inc. has entered a joint venture to establish their first cannabis-testing lab in California. They will be working with Don Ashley, an experienced real estate developer and cannabis entrepreneur, to launch Humboldt Botanical, LLC, conducting business under the name “Digipath Botanical Testing”.

Ashley says they expect to be fully operational by Q1 of 2018. “We expect to break ground on this project in the next few weeks and hope to be operational in early Q1 2018 just after the state-wide adult-use market is expected to launch, as we have already obtained approval from the local planning authorities for the entire complex,” says Ashley.

Todd Denkin, founder and president of Digipath

Todd Denkin, president of Digipath, is optimistic for California’s market and the coming regulations. “The state of California is estimated to be the single largest cannabis market in the U.S. Adult-use cannabis legislation was approved by California residents last November, and we expect these new regulations to be implemented in 2018,” says Denkin. “The good news for the industry is that the requirements for cannabis testing will be significant, and we are excited to partner with Don and his team to pursue this opportunity in Humboldt County.”

Ashley is contributing roughly $2 million to build and equip the lab with instrumentation, while Digipath Labs will manage and supervise operations at the lab. According to the press release, Digipath will provide a non-exclusive license to use its intellectual property for the operation of the lab. Digipath Labs will retain rights over all the scientific data generated in the lab.

Cindy Orser, PhD., chief science officer at Digipath

According to Cindy Orser, PhD., chief science officer at Digipath, that data will be put to good use. “Digipath Labs has developed an algorithm for use in strain authentication based largely on terpene profiling from our testing lab in Nevada and we are eager to further test our hypothesis with an expanded dataset from cannabis grown in Northern California,” says Orser.

While testing labs are primarily seen as safeguards for public health and safety, using data to correctly identify strains is a relatively new concept. “Digipath Labs is all about public health and safety through testing for adulterants,” says Orser. “Another component to quality is having confidence in product authenticity at the dispensary level. Not only is the consumer buying quality assured products but truth in advertising when it comes to strain nomenclature.”

Denkin says they were proactive in working toward getting the license early on. “Our partners have been dealing with the local regulators while we have been providing the proper SOP’s for the local government in order to receive the proper licensure in the area,” says Denkin. Taking their experience from Nevada to California, Orser says they have been asked to present to the California Toxicology Association on their experience with cannabis testing in the highly regulated marketplace of Nevada.

The laboratory in Humboldt is going to be part of a “cannabis industrial park,” alongside an R&D facility, oils/concentrate manufacturing center, health and wellness center, distribution and processing facility, tissue culture nursery, hemp clothing outlet, and coffee bistro, according to the press release.

Looking forward to growing their business, Denkin says they hope to launch a lab in Southern California. “We do expect to have a larger footprint in California because of the size of the market and are looking for locations in Southern California as well,” says Denkin. When asked about any new plans to expand elsewhere, Denkin says they’ll let us know. “We are continuing with our business plan and actively seeking the right mergers and acquisitions. Stay tuned.”

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EVIO Labs Expands To Florida

By Aaron G. Biros
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Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.

Chris Martinez, co-founder and president of EVIO Labs Florida

When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.

Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.

The EVIO team is using instruments from Shimadzu

EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.

According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.

Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.

Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.

When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.

In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.