Those who manage cannabis or hemp testing labs in the US have had to face numerous challenges since the industry got its start, including frequently changing or non-existent regulations and standards, which have contributed to accuracy issues, becoming certified, and setting up and operating their labs. However, recent developments show those issues are slowly being resolved as more regulatory bodies get involved in the industry and communication between testing labs and regulatory groups gets stronger.
In this eBook, you’ll learn about:
- Recent trends in cannabis and hemp testing
- Cannabis reference standards
- Cannabis: greater consistency through homogenization
- Genetic testing is key for successful cannabis engineering, production, and purchasing
- The growing market for cannabis extraction
48078_LM_Cannabis_eBOOK_JL (1) (1)
? Recent Trends in Cannabis and Hemp Testing
? Cannabis Reference Standards
? Cannabis: Greater Consistency through Homogenization
? Genetic Testing is Key for Successful Cannabis Engineering, Production, and Purchasing
? The Growing Market for Cannabis Extraction
Recent Trends in Cannabis and Hemp Testing
Navigating issues in regulations and standards, testing accuracy, setting up and running a cannabis testing lab, and certification
by Rachel Muenz and Ajay Manuel, PhD
Those who manage cannabis or hemp testing labs in the US have had to face numerous challenges since the industry got its start, including frequently changing or non-existent reg- ulations and standards—which have contributed to accuracy issues—becoming certified, and setting up and operating their labs. However, recent developments show those issues are slowly being resolved as more regulatory bodies get involved in the industry and communication between testing labs and regulatory groups gets stronger.
Regulation and standards-related challenges
When it comes to cannabis and hemp testing, regulations that do exist vary from state to state and change often, while the fact that cannabis remains illegal at the federal level brings another set of challenges. However, there are signs that the industry is gaining more stability in terms of standards and regulations, not only making managing a cannabis or hemp lab a little less stressful, but, more importantly, ensuring the safety and quality of these products for consumers.
More consistency seems to be on the horizon as more regula- tory bodies engage with various scientific groups, such as the Association of Official Agricultural Chemists or AOAC In- ternational, and those groups continue to work on developing standards for cannabis and hemp testing. For example, AOAC has established its Cannabis Analytical Science Program (CASP), which provides a forum for the discussion of hemp and cannabis science and the development of standards and methods for the industry.
According to experts in the cannabis testing industry, there are a few key trends regarding regulations that will have a positive impact:
Non-scientist regulators continue to be “more willing to embrace and learn science”
The establishment of the Cannabis Regulators Association (CANNRA) cooperative, which involves more than 30 state regulatory bodies
The regulatory infrastructure is becoming more central- ized, meaning more consistency
Strong collaboration between all stakeholders (scientists, testing labs, regulatory agencies, etc.)
These trends mean that all stakeholders in the cannabis testing industry will be better served. However, though many in the industry are optimistic about these recent trends, it will likely still take time for convergence on regulations to fully develop.
Accuracy issues in cannabis and hemp testing labs
Without standardized methods for cannabis and hemp testing labs, testing accuracy has been an issue as results can vary
Cannabis Resource Guide
Cannabis Resource Guide
greatly from lab to lab. That has also led to so-called lab shop- ping, where, if those producing cannabis or hemp products get an unfavorable test result at one lab, they will simply go to another lab or have the test re-run with a less sensitive meth- od until they get the results they want. Labs have thus been penalized for having more sensitive and accurate methods through the loss of customers.
However, this issue is slowly getting resolved as regulatory bodies continue to work with testing labs and other groups to develop standardized testing methods. Proficiency testing (PT) is also helping to ensure consistency and quality among
the results produced by various labs. Though it’s not required for all cannabis and hemp labs, more in the industry are adopting proficiency tests, in what is a larger move toward implementing processes such as good manufacturing prac- tices, which will only improve the consistency and quality
How to set up and run a cannabis testing lab
As more states legalize cannabis and regulations continue to evolve, the need for cannabis and hemp testing labs is expect- ed to continue increasing. Those looking to set up a hemp
or cannabis testing lab will want to do the following before getting started:
Define the goals of the operation
Figure out what the lab will test and where it will be located and licensed
Determine the types of testing the lab will perform
Research the legal requirements for testing in the market where the lab is located
Once these steps are completed, the organization should have a good idea of the instrumentation needed for the lab and the performance they’ll require from the lab itself, which will in turn determine the budgets and
As with any lab, staffing is especially important in canna- bis testing as, while there are still routine tasks that many
workers can do, the industry requires those with the technical expertise to understand the technologies and instrumentation
used and who can make key decisions for the lab. The benefits of analytical tech and instrumentation in the cannabis testing space can only be realized by staff who know what they
Ensuring a successful lab certification process
Once labs are up and running, becoming ISO/IEC 17025 accredited is another key step to help ensure high-quality testing. The increasing number of cannabis and hemp testing labs seeking ISO/IEC 17025 accreditation, even those whose states don’t require it, has been observed as another positive move toward consistency in testing among labs.
For those labs being certified for the first time, there are a few key points to follow to ensure success, according to both labs that have been through the process and organizations such as A2LA that help labs become ISO/IEC 17025 certified:
Be prepared for the process to take longer than you expect
Make sure you understand how your state implements ISO/IEC 17025 certification, as it varies
When writing your SOPs, be sure to consider what your future testing volume is likely to be
If you have no experience with ISO/IEC 17025 accredita- tion, bring on a trusted partner who does
For proficiency testing, develop a strong relationship with regulatory contacts early and do practice tests to ensure the lab fully understands the rules and is proper- ly prepared
While certification goes a long way to helping testing labs ensure they produce accurate results, the industry does still face challenges in ensuring all labs are regularly following the policies required to be accredited. Though this and other challenges continue to persist, those in cannabis and hemp testing agree the industry has come a long way from its beginnings when there was essentially no oversight at all. Al- though the testing industry still faces a number of issues as it continues to mature, recent trends indicate that it is progress- ing to a point where clear regulations and definitive standards will be the norm.
Cannabis Reference Standards
Overcoming Labryinthine US Regulations
by Angelo DePalma, PhD and Ajay Manuel, PhD
All analytical sciences rely on reference standards—standard- ized, punctiliously prepared and characterized samples—to guarantee the veracity of their results but even more impor- tantly, of their methodology. Cannabis is a complex botanical capable of generating numerous downstream products, each with unique critical quality attributes. And, as a botanical, it is itself an extremely complex matrix.
The terms ‘reference standard’ and ‘reference material’ are often used interchangeably but are not the same thing. A ref- erence material is a substance, botanical, or a multi-compo- nent preparation from the plant, whereas reference standards are single chemical compounds or pure substances of known concentrations, which may be directly compared with values from samples after constructing an appropriate concentra- tion graph.
Experts consider a taxonomically identified plant, in its flowering state, as the gold standard of botanical identifi- cation. Such a plant would always suffice as valid reference material for other botanicals. As flowering plants are not always available, researchers rely on several different levels of authentication.
Variations on the authentication process commonly used to create valid botanical reference materials require identifi-
cation methods with reasonably high specificity, along with a reasonable number of closely related species and/or plant parts, so as to rule out a pure specimen from a closely relat- ed species.
The creation of botanical reference materials hinges on compiling all available characterization resources to bear on qualified botanical materials. According to experts, consider- ations such as the source and documentation provided help ensure sample authenticity and evidence for chain of custody. It is recommended that the analytical methodology, as well as the documentation supporting authenticity, are robust and reproducible.
In some instances, a component or phytochemical unique to the reference material or species under investigation may be used to identify plants. For cannabis, that compound would be Tetrahydrocannabinol (THC) since it is found nowhere else in nature. This approach is not without its flaws as research- ers have demonstrated that most botanicals lack specific compounds that distinguish them from other species. As phytochemicals are quite ubiquitous, they cannot be used as
a definitive category of identification. A laboratory’s preferred analytic methodology and instrumentation always factors in decision-making on reference standards and materials.
Reference standards versus reference materials
Various standards exist for botanical products, including for analytes like heavy metals or pesticides that are prepared
at specific concentrations in a designated solvent. Reference materials and standards that match the sample’s matrix may be authentic reference material with known or designat-
ed amounts of, for example, pesticide residues. An ideal matrix-matched standard for cannabis might consist of a cannabis plant standardized for the different analytical targets
Cannabis Resource Guide
Cannabis Resource Guide
such as terpenes, heavy metals, pesticides, psychoactive ingredients, etc.
Labs requiring traceable quantitative standards should be using certified reference materials (CRMs) as their primary standards. The international standard governing the manu- facture of reference materials, ISO 17034:2016, mandates that the standards be metrologically traceable, and that manu- facturers report certified concentrations with corresponding measurement uncertainties which guarantees end users that reported measurements agree with results obtained from oth- er labs using the same standard. Proper instrument calibration is crucial to achieving traceability between labs.
Single-component CRMs allow labs to create their own multi-component control samples at varying concentrations, while a multi-component CRM may be ideal when creating calibration standards and can help reduce dilution errors,
material consumption, preparation time, and provide a means to create flexible standards that fit specific test requirements.
Accuracy is paramount
The status of cannabis as a Schedule 1 drug under the US Controlled Substances Act is the primary barrier to estab- lishing standards and uniform protocols in cannabis testing. As cannabis is federally illegal, it is difficult to get permission for cannabis research or provide adequate regulation and guidance around cannabis testing. Current law forbids even the transportation of THC-containing cannabis products between US states. This leaves regulating cannabis testing to local jurisdictions to keep potentially impure or dangerous products off the market. Regulatory hurdles to using cannabis reference materials depend on a lab’s status. That being said, accuracy (trustworthiness) is paramount and is a major factor for why the selection of a testing lab is not to progress without careful guidance and screening.
Cannabis: Greater Consistency through Homogenization
High-pressure homogenizers generate the most consistent and stable cannabis emulsions
by Brandoch Cook, PhD
There are currently four cannabinoid-related, FDA-approved medicines. Because of regulatory oversight, such medicines must conform to GCP/GMP standards and be available in potencies and dosages that are consistent and reliable. How- ever, in the basic research and pre-clinical phases of cannabis pipelines, and especially in the consumer marketplace of cannabinoid tinctures and panaceas, what you see is not nec- essarily what you get.
In testing at a recent California Emerald Cup cannabis festival, only about 30 percent of cannabidiol (CBD) products contained the claimed percentage of CBD, and several tetra- hydrocannabinol (THC) products contained no active THC. These discrepancies can also swing the other way, and several anecdotal and news reports since state-specific legalization took hold have described users ingesting what they thought were safe doses, then spending time in hospital with severe panic attacks. For cannabis research laboratories, it may therefore be difficult to secure approved suppliers who can guarantee accurate measurements of cannabinoid potency, although an assiduous focus on consistency as the industry matures can change that for the better. For now, the recent emergence of cannabis as a legal entity, and its persistence as a Schedule 1 substance, precludes a federal regulatory frame- work and state-to-state distribution networks. Moreover, broad resistance to creating a Big Cannabis industry in the
mold of Big Pharma has often prioritized the unique qualities of industry culture over the uniformity of product.
The foundation of consistency is in the attention paid to the homogenization step before extraction. It is a necessary prelude to isolating and quantifying active extracts, and to
testing for impurities and contamination. Downstream anal- yses rely on chemistry-intensive expertise and complicated instrumentation, such as gas chromatography, liquid chroma- tography, and inductively coupled plasma mass spectrometry to quantify cannabinoids and terpenes, and to ensure safety from heavy metal and pesticide contamination. The asso- ciated time and expense alone provide strong disincentives against failing to respect these steps, and clear results can only be obtained with uniform emulsions of starting material.
Cannabis emulsions can be created using hotplate stirrers, rotor-stator homogenizers, or with high-pressure or ultra- sonic homogenization. Emulsions with the smallest particle size maintain the longest stability and improve quality by maximizing the bioavailability of active ingredients. Some rotor-stator homogenizers can achieve very small particle sizes between 0.01 microns and 10 nanometers.
Ultrasonic homogenization is unrealistic at scale because of the smaller volumes sonicator horns can contact and efficient- ly disrupt. High-pressure homogenization (HPH) performs much better with higher volumes and greater viscosities.
Powerful disruptive energy emanates from the relaxation of pressure buildup across a valve, resulting in shear, turbulent, and cavitation forces. Valve geometry in addition to tightness and pore size can contribute to changes in exit pressures, resulting in proportionally small particles. Microfluidizers are modifications of HPH and allow even higher pressures within an internal fixed chamber, eliminating some mainte- nance worries associated with moving parts. A move toward optimization and standardization of homogenization steps will be crucial in the future growth of the cannabis industry and medical research field.
Cannabis Resource Guide
PRO Scientific Homogenizers for QC Testing & Sample Preparation
PRO Scientific manufactures five-star homogenizing products for sample preparation, assisting both small startup and established labs with their cannabis testing and quality control as well as the creation of infused products.
Testing within the cannabis industry demands an accurate homogeneous product to assist in determining and monitoring the cannabinoid potency and pesticide residue. PRO Scientific homogenizers are durable and PRO Quick Connect Generator Probes are precision
designed meaning you get the results you need time and time again.
PRO’s high shear homogenizers and probes are also capable of homogenizing down to a
sub-micron level. This makes PRO homogenizers ideal for the extraction of cannabis and for the development of cannabis-infused products where the creation of a shelf-stable emulsion is essential.
Genetic Testing is Key for Successful Cannabis Engineering, Production, and Purchasing
Scientists are getting closer than ever to linking genotype and phenotype—with significant implications for the industry
by Michelle Dotzert, PhD, and Ajay Manuel, PhD
The term “entourage effect” describes the combined effects of cannabinoids and terpenoids on the consumer’s psycholog- ical perception of different cannabis varieties. Each variety, or strain, contains varying concentrations of cannabinoids, including psychoactive tetrahydrocannabinol (THC) and non-psychoactive cannabidiol (CBD), and has a unique ter-
penoid profile. As such, consumers are able to choose cannabis based on a desired effect, such as relaxation, and a specific aroma. Despite widespread information on the characteris- tics of different strains, the underlying genetic information accounting for these differences remains poorly understood. Genetic testing will prove beneficial for cannabis breeders, producers, and consumers. Further, for breeders and produc- ers, the ability to determine the sex and cannabinoid type of young plants is crucial.
A Quick Lesson in Plant Biology
Cannabinoids and terpenoids are primarily concentrated in cannabis flowers, specifically within the glandular trichromes which are modified hairs and broadly occur across flower plants. Glandular trichromes can evolve into specialized anatomical structures that synthesize and store complex mixtures of metabolites such as oils or resins. Despite their concentration within the same structures, cannabinoids and terpenoids do not share biosynthetic pathways but are formed from the same chemical building blocks. Compounds such as sesquiterpene and monoterpene are enzymatically synthe- sized from isopenteneyl diphosphate (IPP) precursors, the latter being fundamental to the side chain portion of many cannabinoids.
Cultivars are plants that share morphological, physiological, and chemical characteristics, and maintain these character- istics through reproduction. As such, cultivars are defined by phenotype, not genotype. A chemotype (or chemovar) is
classified based on chemical composition, including cannabi- noids and terpenes. Three particularly important chemotypes are THC (type one), about equal THC:CBD (type two), and mostly CBD (type three). In recent years, researchers have worked out the genetic basis of these chemotypes and have discovered that they can be traced to a single major locus.
Developing Rapid Assays
Researchers also observed that event in chemotype three plants, that produce mostly CBD, the amount of THC is directly proportional to the amount of CBD. This meant that any plant that produces more than a certain threshold of CBD, about seven percent, would also produce non-compli- ant levels of total THC. This is problematic for growers who must remain compliant and highlights the need for a way to identify plants that will produce too much THC. As such,
Cannabis Resource Guide
Cannabis Resource Guide
various assays have been developed to identify plant sex and cannabinoid type.
Combining Metabolomics and Transcriptomics
Using RNA-seq and algorithms, distinct gene networks have been identified in cannabis strains. According to experts, RNA-seq offers some advantages over other genotyping methods as it does not require any prior knowledge but provides an accurate account of all genes expressed above
a certain threshold in the specific tissue or cell type under consideration. Gas chromatography (GC) and liquid chroma- tography (LC) have also been used to separate and quantify cannabinoids and terpenoids with results revealing a tight correlation between biosynthetic genes and cannabinoid and terpenoid products.
How Genetic Testing May Impact the Cannabis Industry
From cannabis breeders and producers to sellers and consum- ers, the benefits of genetic testing span the entire industry.
Experts believe that combining metabolic and transcriptomic
data provides a means of unifying consumer needs (unique chemotype cultivars) with cultivar developer needs. While chemotype (metabolic data) will remain the benchmark for the investigation and development of cultivars catered to- wards customer interests and therapeutic needs, genomic and transcriptomic data can help in validating cultivar breeding and engineering.
Practical and Legal Challenges Remain
Cannabis genome testing provides a wealth of valuable infor- mation. From helping growers remain compliant with respect to THC content, developing new cultivars, and helping consumers make informed purchasing decisions, the plant’s genetic information is key. Nevertheless, there remain various practical issues that must be addressed including the mix up of samples from plant to the lab, the requirement for special- ized equipment, high costs per sample, as well as legal and regulatory challenges.
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The Growing Market for Cannabis Extraction
From alcohol to carbon dioxide, a range of techniques support this expanding market
by Mike May, PhD
Hundreds of chemicals exist in cannabis—these include the psychoactive tetrahydrocannabinol (THC), the purportedly medicinal cannabidiols (CBD), and many more. Plant proces- sors and product manufacturers use a variety of extraction techniques to obtain the component chemicals. If nothing else, the growing number of signs advertising CBD-based products provides some indication of the increasing use of cannabis extraction.
The idea of extraction is straightforward: remove the chem- ical components from a cannabis plant. In practice, it gets more complicated. First, some chemicals are more desirable than others in a particular product, and some methods of ex- traction do a better job of isolating specific components. Next, the resulting extract must be safe for its intended purpose. For example, nothing dangerous should be left in the final extract, such as a solvent used in extraction, or a pesticide used in growing. Given that cannabis extraction is a business, the method should also provide the needed level of throughput
at an affordable cost. Meeting all those caveats turns cannabis extraction into a competitive industry.
Cannabis extraction can be divided into two major categories: methods that use a solvent and ones that don’t. There are sev- eral solvent-based methods, including extraction with butane, ethanol, isopropyl alcohol, propane, and supercritical carbon dioxide (CO2). There are also solvent-free methods including sieve extraction, water extraction, and rosin press extraction.
Among these methods, ethanol is considered the cheapest and most scalable. It can also be easy: soak the cannabis in ethanol, remove the plant pieces, filter the remaining liquid, remove the ethanol with evaporation, and that just leaves an extract. This, though, is a bit too simple for most industrial applica- tions, which would at least include some other steps, such as distillation.
Every method offers some benefit, and probably a shortcom- ing or two. For lower costs, experts suggest a CO2-based method, which requires the fewest clean-up steps. Some methods are also riskier than others such as butane-based extractions which have a high potential for explosions.
Carbon dioxide is king
The benefits of CO2-based extraction trigger wide use of this method as the scale and throughput of CO2 extractors is con- siderably larger and has continued to grow. Among the many advances made in cannabis extraction, the ability to produce nature-identical extracts using CO2 extraction has been tout- ed by many to be the most impactful. This has helped deliver bioactive replica of cannabis cultivar while maximizing THC content in an extract.
Ultimately, scientists will develop easier and more efficient ways of extracting more-targeted components from canna- bis. In many ways, this young industry continues to evolve from garage-based methods to processes using commercial equipment—some of it now dedicated to cannabis extraction. Not too many years ago, some major instrument makers
Cannabis Resource Guide
Cannabis Resource Guide
requested—even insisted—that none of their devices should be linked to cannabis extraction. Now, many publish specific
cannabis extraction workflows. What a difference a few years, and some changing laws, can make in an industry.
PRO Scientific is a global leader in the manufacturing of homogenizers for both laboratory and industrial labs. PRO homogenizers can homogenize various types of material to allow for uniformity and consistency.
PRO Scientific manufactures high-quality homogenizing products for sample preparation within the cannabis industry. These precision homogenizers help create uniform homogeneous mixtures that are necessary for determining and monitoring potency and pesticide residue as well as creating shelf-stable products. From micro sample volumes to larger multi-liter processing, there is a PRO Homogenizer to suit your needs. PRO Scientific even offers homogenizing solutions to address your automated multi-sample homogenizing and OEM homogenizer needs.
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Cannabis Resource Guide