The legalization of cannabis in different states in the US has resulted in a rapid expansion of the industry. It is predicted that the regulated cannabis industry will reach $82.3 billion by 2027. The primary factors contributing to the growth of the cannabis industry are the increasing acceptance and legalization of cannabis for both medical and recreational purposes. This trend is expected to continue as more states realize the potential advantages of legalizing cannabis, including generating more tax revenue, creating job opportunities, and providing medical benefits. The legalization of cannabis has also stimulated new research and development, leading to innovative new products. The expansion of this industry is being propelled by the growing popularity of cannabis commodities, such as edibles, oils, and tinctures, among consumers. This has resulted in a wide range of opportunities for both entrepreneurs and investors. Thus, we are observing the emergence of various cannabis-related enterprises, which include those engaged in the growing, processing, testing, and distribution of cannabis products, as well as those providing legal, financial, and consulting services.

The industry has a lot going for it. Nevertheless, despite the early successes, it has experienced some obstacles, one of which gained attention in 2022 – the problem of THC inflation. The issue has caused extensive laboratory shopping as cultivators strive to acquire the greatest THC concentrations in their products.

THC Inflation, Lab Shopping, and the Vicious Cycle

THC inflation refers to the act of falsely elevating THC levels in a sample to show a greater THC concentration than what actually exists. Strains with less than 10% THC are classified as low THC strains, while those with over 20% THC are considered high THC strains.

As a result of THC inflation, the lab shopping trend has emerged, in which unethical producers search for laboratories that falsely enhance THC levels. This activity has become so common that certain labs openly promote their services based on the high THC numbers.

Many people who use cannabis believe that products containing higher levels of THC always produce stronger effects. However, this is a mistaken belief, as the potency of a cannabis product cannot be determined solely by its THC content. The misconception has contributed to an exponential increase in demand for high-THC products. As a result, consumers are willing to pay more for these products. The emphasis on high-THC goods has given rise to fraudulent laboratories that deliberately inflate THC levels. Unethical producers are attracted to these laboratories, while ethical ones experience a decline in their business. This practice brakes consumer trust and undermines the industry’s credibility. If labs continue to allow the labeling of products with falsely high potency, customers will lose faith in the regulated market.

Breaking the Cycle: Addressing the Twin Trends of THC Inflation and Lab Shopping

The absence of standardized testing procedures in the industry is leading to mounting concerns about THC potency inflation. This is due to variations in the methodologies and equipment used by different labs, resulting in inconsistent test results. Unethical labs take advantage of this and report exaggerated THC levels. Moreover, the scope for manual intervention allows dishonest labs to manipulate results and deceive regulatory agencies.

Some of the ways to control THC inflation are outlined below:

• It is crucial to establish a universal testing standard within the industry.
• The same samples should be analyzed by multiple labs, and any anomalies should be recognized. States should then promptly act against labs that report inflated THC numbers knowingly.
• It is important to eliminate the motivation for inflating THC potency. This can be achieved through various measures such as promoting transparency among labs, conducting regular audits by state regulatory bodies to detect any data inconsistencies or inaccuracies, and hiring expert data scientists by state agencies. This, in turn, will boost consumers’ confidence in the regulated market.
• It is also essential to dispel the incorrect belief that higher THC levels are the only reliable indicator of potency. Raising awareness and promoting effective communication in this regard would help tackle the problem of THC potency, thereby reducing the occurrence of lab shopping.
• Lastly, laboratories must obtain accreditation to ISO/IEC 17025 to demonstrate their proficiency in generating reliable results.

Image 1: A diagrammatical depiction of diverse strategies aimed at controlling the prevalence of THC inflation and lab shopping in the cannabis industry (Figure courtesy CloudLIMS)

Why Cannabis Lab Testing Software?

A Laboratory Information Management System(LIMS), also known as cannabis lab testing software, can assist in fulfilling the ISO 17025 requirements effortlessly, which can increase the level of trust and assurance in the precision of the laboratory’s test results.

The adoption of cannabis lab testing software can be a game-changer. By integrating analytical instruments and ensuring strict adherence to quality standards, cannabis lab testing software automates processes, thus minimizing the potential for human error in test results. And that’s not all. With cannabis lab testing software, reports can be generated with a scannable QR code, which can be easily shared with customers in real-time. This QR code can also be configured to lead to the original CoA generated by the lab, allowing consumers to verify the composition of the product they’re purchasing. This not only fosters transparency but also instills greater trust and confidence in the products customers consume.

Cannabis lab testing software ensures the authenticity and reliability of laboratory data. The system leaves no room for manual manipulation. It tracks and records every laboratory activity with utmost precision, from staff login activities to changes in documents, sample records, and test results. Maintaining high-quality standards is paramount to establishing the credibility of results, and cannabis lab testing software helps accomplish it. It effectively manages QC sample results and identifies analytical errors by comparing them with the test samples, providing an added level of trust in the lab’s results.

Image 2: A cannabis lab testing software to record all laboratory activities with a date and time stamp (Figure courtesy CloudLIMS)

Conclusion

The legalization of cannabis in most US states has led to a rapidly expanding industry. However, the industry has faced obstacles, including the issue of THC inflation and biased selection of labs, which undermine the credibility of the regulated cannabis market. The absence of standardized testing procedures and the variation in methodologies and equipment used by different labs are gaps that corrupt labs have taken advantage of. To address these issues, it is crucial to establish a universal testing standard, enhance transparency among labs, and state agencies must conduct regular audits and recruit skilled data scientists. The adoption of a LIMS by cannabis testing labs can assist in fulfilling the ISO 17025 requirements, thus increasing the level of trust and assurance in the accuracy of the laboratory’s results. With the right measures in place, the cannabis industry can continue to grow and thrive, providing medical benefits and job opportunities, and generating more tax revenue.

About Astrix

Astrix is the unrivaled market leader in creating & delivering innovative strategies, technology solutions, and people to the life science community. Through world-class people, process, and technology, Astrix works with clients to fundamentally improve business, scientific, and medical outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of fully integrated services designed to deliver value to clients across their organizations. To learn the latest about how Astrix is transforming the way science-based businesses succeed today, visit www.astrixinc.com.

About the Author

Montserrat Valdes is a highly skilled chemical engineer with a diverse background in research and industry. She holds a Master of Science degree in Chemical Engineering from the University of Saskatchewan and an Analytical Chemistry Diploma from the National Autonomous University of Mexico. Currently, Montserrat is working with CloudLIMS.com as a Scientist.

Montserrat is an experienced chemist with expertise in the analysis of cannabis and nicotine-containing products. As a QC Chemist and Analytical Chemist, she has conducted numerous accredited testing methods to ensure the quality and compliance of cannabis products. Her experience also includes validating analytical testing methods and operating, calibrating, and troubleshooting a variety of analytical instruments, including HPLC-FLD/DAD/VWD, IC, and LC-MS.
In addition to her work as a chemist, Montserrat has also served as a Research Engineer, successfully coordinating various environmental projects of great importance. These projects include the simultaneous capture of NH3 and H2S using nanoparticles, the biodegradation of surrogate naphthenic acids, and the adsorptive removal of antibiotics from livestock waste streams.

Montserrat has also made significant contributions to scientific literature through her research articles and conference presentations. Her publications in journals such as the Journal of Environmental Chemical Engineering and Bioprocess and Biosystems Engineering highlight her expertise in topics ranging from nanotechnology applications to biodegradation and wastewater treatment.

The post Breaking the Cycle: Effective Strategies for Cannabis Testing Labs and Regulators to Address THC Inflation and Lab Shopping appeared first on Astrix.

With the legalization of both adult recreational and medical cannabis in a variety of states, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug/product potency. Growing numbers of laboratories that specialize in evaluating cannabis and cannabis products are emerging to fill this niche. Typical lab testing on cannabis botanical samples includes:

• Potency
• Terpenes
• Strain (terpene/cannabinoid ratios)
• Residual solvents
• Pesticides
• Heavy metals
• Water activity
• Moisture content
• Foreign materials
• Mold and microbiological contaminants

Cannabis testing labs typically receive high volumes of test requests from cannabis growers and/or cannabis product manufacturers, and these labs need to develop effective data management strategies to stay competitive and maintain regulatory compliance. Using manual, paper-based methods (e.g., spreadsheets, notebooks, etc.) to gather, organize and control laboratory testing data is error-prone and time-consuming, especially as testing volume increases.

A Laboratory Information Management System (LIMS) is a software tool that allows for efficient data management and laboratory operation. LIMS can help to ensure regulatory compliance and provide the accurate and speedy results, reports, and certificate of analyses (COA) that are required for cost-effective operation in today’s highly competitive cannabis testing market. In this blog, we will discuss some LIMS features that can benefit cannabis testing laboratories, along with best practices for ensuring a successful LIMS implementation in your lab.

LIMS Features and Functions

Cannabis testing labs have to be able to stay in sync with the rapidly evolving regulatory requirements in this new and fast-growing industry. These labs also need to be able to operate cost-effectively and provide accurate and timely results to maintain competitiveness. LIMS provides a single, centralized database for all testing data, enabling effective data management and accessibility, along with a defendable quality assurance/control (QA/QC) framework to meet regulatory compliance.

LIMS provides data security and traceability from the moment a sample arrives in the lab, all the way through to final reporting and disposal. The LIMS tracks all testing data and parameters tested, along with corresponding test methods and paperwork (converted to PDF format) associated with the work order.

LIMS can track and manage other laboratory data as well to help ensure quality is maintained and operations run smoothly. For example, LIMS can be utilized to track reagent and supply expirations, incubator and freezer temperatures, instrument calibrations and employee training schedules and/or status.

A few of the many useful features and functions that LIMS can provide to cannabis testing labs include:

• Sample and split-sample tracking, allowing for an accurate chain of custody
• Positive ID (RFID, barcoding) from login to final disposition
• Chemicals, reagents, standards and supply inventory, order management and tracking
• Equipment management – maintenance and calibration schedules tracked
• Manual or automated (via instrument integration) data entry/transfer
• Stability testing modules
• Document management – method versioning, SOPs, manuals, etc.
• Resource management – instrument records, employee training records, etc.
• Workflow management – promotes better workflow efficiency and resource allocation
• Records comprehensive audit logs for laboratory activities along with the date and time stamp
• Data security and confidentiality – masks sensitive data from unauthorized user access
• Quoting and invoicing
• Integration with industry (e.g., seed-to-sale software, dispensary software, etc.) and enterprise (e.g., ERP, etc.) solutions for efficient data transfer, regulatory compliance and seamless accounting
• Automated and real-time reporting via export to a web portal or email
• Integrated web portal for 24/7 result access, sample submission, and locked report downloads
• Support for regulatory compliance and/or accreditations – ISO/IEC 17025, ISO 9001:2015, GLP, 21 CFR part 11, etc.

LIMS Implementation Methodology

Selecting, implementing and integrating a LIMS solution can be a challenging endeavor. In fact, nearly half of LIMS projects fail to meet one of more of the following metrics:

• is delivered on time and within budget
• meets or exceeds all user and technical requirements
• provides significant business value
• achieves a high-level of user adoption.

In order to ensure success, a comprehensive and proven methodology should be followed. This methodology should include strategic planning that leverages a workflow and business analysis to generate a set of optimized future-state requirements that will maximize business value for your organization. Instead of trying to implement a LIMS based only on your current workflows, why not implement your project in a way that optimizes your business? Without a clear strategic plan, companies often implement solutions in ways that do not support the business’s future goals.

Once a set of optimized future-state requirements are generated, it is time to select the LIMS that is the best fit for your system requirements. Care should be taken to choose the optimum hosting solution for your LIMS, which for cannabis labs is often a cloud-based system. Given that there are several LIMS options now on the market that are specifically designed for the cannabis industry, the selection process should be sure to include these vendors in the evaluation. Whatever system is chosen should be highly adaptable to enable staying in sync with the rapidly evolving regulatory requirements in this industry.

Finally, the project team should have significant technology expertise and experience designing, implementing and integrating complex solutions in a validated environment.

Conclusion

Given the highly competitive and rapidly changing nature of the cannabis industry, a LIMS is a necessity for high volume cannabis labs. In addition to reducing manual workloads and enhancing operational efficiency, a LIMS supports effective data management and security, along with regulatory compliance.

Astrix Technology Group has over 20 years of experience facilitating success in LIMS implementation projects. Since 1995, our professionals have successfully applied best practices in the evaluation of work processes, functional and technical requirements, laboratory processes and LIMS solution options for hundreds of clients and tens of thousands of scientists in a wide range of industries. Our exposure to hundreds of customer initiatives and expertise with many different LIMS allows for an enhanced understanding of what might be possible to optimize your laboratory environment.

The post Benefits and Best Practices for LIMS Implementation in Cannabis Testing Labs appeared first on Astrix.