The cannabis industry has reached a tipping point - with many important developments and breakthroughs now in focus. Despite progress on all fronts, hurdles remain in realizing the full potential of medicinal marijuana. The true merits of cannabis hemp depend on continued progress in multiple areas. The climate is right to reap the benefits of this promising therapeutic and industrial crop.

The Future Trends in the Cannabis Industry Interactive Infographic is a living resource keeping pace with the rapidly evolving cannabis industry.

This post serves as a chronology of the infographic, citing ongoing developments in the areas of: Advancements in Instrumentation, Advancements in Research, Testing Standardization, Genomics and Chemotypes, and Quality Control Improvements.


Advancements in Instrumentation


Harvesting

Passage of the 2018 US Farm Bill has enabled large-scale hemp farming by registered cultivators. Re-purposing of equipment from areas such as tobacco farming has allowed harvesters to be adapted to handle the multiple challenges of hemp farming. Innovations in harvesting equipment and methods can now specify distinct hemp plant varieties, growth density, and plant stalk processing, for textile versus CBD oil production.

  • 10/2019 - Automated control systems are now built into modern harvesting equipment, enabling efficient removal of buds and flowers from plants during early processing.
  • 11/2019 – Hemp field point-of-use analytics for on-site testing is in the development phase and gaining momentum. The USDA rolls out the Domestic Hemp Production Program.
  • 12/2019 - The USDA is creating the country’s first hemp seed bank with the help of Cornell AgriTech.
  • 1/2020 – Automation is taking a front seat in cannabis harvesting, as hemp farmers gain expertise and processing systems are being effectively designed and implemented.

Extraction

Innovations in efficiency and safety has made hydrocarbon extraction accessible to a broader range of operations. Supercritical carbon dioxide and other solvent-free extraction techniques have increased efficiency, safety, and yield of cannabis processing. Innovative technologies involving ice-water, sonication, and other techniques are expanding the breadth and depth of extraction capabilities.

  • 10/2019 - Hydrodynamic force and ultrasonication techniques are enabling compound preparation from whole plants. Large-scale on-site hemp farm extraction has become a reality, cutting costs in transportation and logistics.
  • 1/2020 – Sous-vide decarboxylation is gaining popularity as a preparation boutique method for consistent cannabinoid activation.

Purification

Advanced sample enrichment, HPLC column offerings, and LC techniques have enabled high-quality analytical separations and analysis of cannabis compounds. Gas chromatography and GC-MS techniques have supported advanced analysis of organic and volatile terpene compounds. Fractional and thin film distillation techniques adapted from the petrochemical and chemical industries have enabled high purity large-scale cannabinoid isolation.

  • 12/2019 – Increased attention is being focused on water-soluble cannabinoids derived through colloidal purification techniques for better bioavailability and dosage monitoring. Water-soluble cannabinoids taken by sublingual route can have effects in seconds to minutes with little loss of potency, compared to consumables which can take minutes to hours and result in up to 50 percent or more loss in potency.
  • 2/2020 – The concept of “THC Remediation”, to remove “background THC” and permit legal growth and production of CBD hemp, is being addressed by emerging chromatographic, catalytic, and extraction refinement technologies.

Potency Testing

Hemp farming regulations now necessitate potency testing on-site at grow operations. Turn-key solutions are enabling testing by a wider range of operators, experience levels, and in remote processing locations. Third party testing labs and quality assurance labs are strengthening the integrity and safety of cannabis potency testing. Large-scale labs are focusing on potency and contaminants testing specifically for hemp-derived CBD products.

  • 11/2019 – The recently approved USDA guidelines for hemp and hemp-derived derivatives will clarify THC and CBD potency testing as well as quality control standards.
  • 1/2020 – Scientists have discovered two novel cannabinoids in cannabis which are analogues of the well-known THC and CBD compounds. Once of these, THCP, was shown to bind CB1 receptors with 30-fold higher affinity and demonstrated several times the potency of THC in mouse models.

Contaminants Testing

Microbial diagnostic instruments are being developed and deployed on-site at grow operations to detect pests prior to processing. Testing labs are utilizing built-for-purpose PCR, RT-PCR, and test reagents and kits to identify the range of microbes posing a possible threat. GC, LC, MS, and ICP-MS techniques and instruments are increasing the sensitivity and scale of residual solvent and heavy metals detection in processed materials.

  • 11/2019 – Vitamin E Acetate, a THC thinning agent and vaping accelerant, has been targeted as the chemical responsible for the current vaping illness problem. The CDC has published supporting evidence of this finding.
  • 1/2020 - Companies are developing sensitive tests for identifying vitamin E acetate in vaping products
  • 2/2020 – Portable cannabis testing methods and devices aim to detect desirable crops and to offer test accuracy at the source of cannabis production.
  • 2/2020A study has demonstrated the formation of hydrogen bonds between THC and Vitamin E Acetate in un-vaped, aerosolized, and condensed aerosol e-liquids.

Advancements in Research


State Research Initiatives

Certified medical cannabis academic clinical research centers have been established. States now sponsor medical cannabis research grants in areas including autism, opioid abuse prevention, neurological diseases, and others. Passage of the Medical Cannabis Research Act will allow increased numbers of federally-registered manufacturers of cannabis for legitimate research purposes. State universities are now offering advanced degrees and certificates in medical cannabis research, operations, policy, and industry consulting.


Federal Research Funding

US federal agencies now fund research regarding the impact of cannabis on: opioid abuse, pain treatment, prenatal and adolescent exposure, mental and mood disorders, HIV, and others. Federal funding programs include research into quality control, potency testing, and other analytical considerations.

  • 10/2019 - The DEA has reiterated the promise to prioritize cannabis research. The US plans the invest 3 M to research the use of CBD as a therapeutic platform. 
  • 12/2019 - Ziva Cooper, research director of the UCLA Cannabis Research Initiative, has been awarded a $3.5 million grant from the National Institutes of Health to conduct a five-year study assessing the pain-relieving effects of cannabis and cannabinoids, the chemicals in the cannabis plant.

Clinical Research & Trials

The US FDA approval of pharmaceutical-grade cannabidiol (CBD) and removal of Schedule I substance designation will likely open the door for further research and clinical trials. Private pharma and public research institutions are partnering on clinical research into cannabinoid-based cancer treatments and other areas.

  • 10/2019 - Medical research, trials, and education continue to lag despite expansion of state-level legalization. Health Canada is sponsoring clinical trials on the safety and efficacy of cannabis edibles.
  • 11/2019 - Clinical and preclinical research is accelerating due to expanded hemp production and positive CBD patient data and results.
  • 12/2019 - The FDA has approved a human trials study by the Yale School of Medicine and CT Pharma investigating the effectiveness of cannabis-based medicines; it’s the first cannabis study on human subjects to be approved by the FDA.
  • 1/2020 – A study published in Nature Scientific Reports showed fetal growth restrictions after THC administration using a rat model of pregnancy, supporting some of the fetal development concerns shown previously.
  • 2/2020 – Elixicure, a CBD pain relief topical formulation, is the first over-the-counter CBD drug to be approved by the FDA.

Legal Reform

The majority of US states have legalized cannabis for medical use and several countries have legalized cannabis for medical and recreational use. The end of hemp prohibition in the US is leading increased interest in applied research in areas including cannabinoid production, industrial use, genetics, and other important applications.

  • 10/2019 - Pennsylvania governor has called for complete legalization of recreational and medicinal cannabis. Congress has voted on the historic Marijuana Banking bill.
  • 11/2019 – Positive CBD clinical results are impacting global markets and regulatory reform. The White House has approved interim plans submitted by the USDA to regulate hemp and hemp derivatives. The plan will provide clarity to potency testing and quality control standards.
  • 12/2019 - Members of the United States House Judiciary Committee passed legislation, House Bill 3884: The Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act, which aims to remove the marijuana plant from the federal Controlled Substances Act, thereby enabling states to enact their own cannabis regulations free from undue federal interference.
  • 1/2020 – Having passed the House of Representatives, the US Senate will likely hold a vote in early 2020 on the Secure and Fair Enforcement (SAFE) Banking Act, which allows for businesses to legally engage with financial institutions.
  • 2/2020 - A bill has been introduced to amend the Federal Food, Drug and Cosmetic Act (FDCA) to include hemp-derived CBD as a dietary supplement.

Sponsored Research

Philanthropic initiatives offer support for cannabis research. Private companies now sponsor clinical research into cannabis influences on sleep disorders and a wide range of other indications. Products and technologies as diverse as Legos and the 3-D printing industry have embraced research and development into new sustainable hemp-based manufacturing.

  • 10/2019 - The Journal of Cannabinoid Medicine has been started with the goal to provide the FDA with a reputable source for validated cannabis research.
  • 1/2020 – Atlas Biotechnologies is investing 300M and partnering with University of Alberta in clinical research to investigate whether cannabis can effectively treat multiple sclerosis, Alzheimer’s, or Huntington’s Disease.
  • 2/2020A strategic partnership between Agilent and Lake Superior State University, and the formation of the LSSU Cannabis Center of Excellence (CoE), seeks to facilitate education and research into cannabis chemistry and analysis.
  • 2/2020 – Private beer and cannabis companies, Denver Beer Co., The Clinic, and Earthly Labs are collaborating and exploring methods to capture carbon dioxide from the brewing process, and use this in cannabis cultivation, thereby increasing production, yields, and cost efficiencies.
  • 2/2020Front Range Biosciences is collaborating with CRAC and UC Davis to explore unique traits underlying disease resistance and yield optimization.

Testing Standardization


Universal Validation Methods

Enactment of federal testing mandates of cannabis and cannabis compounds will ease conflicts between growers, processors, and law enforcement. Universal procedures will include testing at the grow, harvest, extraction, formulation, and consumer product stages. Testing sites will benefit from well-validated methods for instrument calibration, accuracy, intra- and inter-day precision, and other figures of merit.

  • 10/2019 - Proficiency testing and harmonization across testing labs is providing a forum to examine test precision, reliability, and product safety.

State Testing Standards

The majority of states have approved medical cannabis programs and state specific testing criteria. Legalization of hemp has accelerated the entry of high CBD, low THC products into the market. Harmonization of state-specific testing criteria will address concerns over product and patient safety – particularly critical now with legalization of interstate hemp commerce.


Federal Guidelines

The 2018 Farm Act declassified hemp, making grow and processing operations legal with certain restrictions and required licensing. The DEA has removed CBD from Schedule 1 drug status and the Federal Drug Administration (FDA) is drafting measures for the regulation and testing of CBD products at the federal level.

  • 10/2019 - The FDA is expediting efforts to develop regulations for CBD, describing it as an important issue for stakeholders, farmers, patients, and consumers.
  • 11/2019 – The USDA is enacting standards for testing quality control.
  • 12/2019 - Based on the lack of scientific information supporting the safety of CBD in food, the FDA has stated that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
  • 1/2020 – The USDA has issued an interim final rule for guidelines regarding proper cultivation, harvest, processing, and testing of legal hemp, along with registration requirements for production. Public comments are accepted through Jan 31, 2020. The interim final rule remains in effect for two years, which allows time both to make it through a full crop cycle and for USDA to deliver a final rule. The USDA has approved the hemp regulatory plans for three states and three Indian tribes based in the interim guidelines.
  • 2/2020 – The USDA has received over 4,600 public comments regarding the proposed hemp cultivation final rules, prior to the deadline for submission.

Cultivation - Process Testing

Testing standardization includes monitoring compound production during cultivation and harvesting. Turn key testing solutions will allow growers to test plants for limits, for instance <0.3% THC in hemp crops, to ensure legal status is maintained. Testing at the post-harvest and extraction stages will confirm yields and legal processing thresholds as well.

  • 1/2020 – Portable testing techniques, such as those employing Near Infrared (NIR) Spectroscopy, are enabling chemical analysis of cannabis at the site of cultivation. Cloud-based applications are enabling point of testing validation with databases to ensure transparency and integrity in production procedures.
  • 2/2020 – The development of handheld scanners, based on Raman or FTIR spectroscopic analysis, may offer cost and safety advantages to hemp cultivators, avoiding crop loss due to elevated and illegal THC levels

Genomics & Chemotypes


Cannabis Genetic Sequencing

The sequencing of the cannabis genome and cannabis subtypes has helped delineate the genes and variations underlying strain specific production of THC, CBD, and other medically important cannabinoids and terpenoids. Further genomic information will assist in selective breeding and genetic modification for select applications.


Public Genomic Databases

Products and services have arisen to support strain-specific genotyping. The use of sequencing information and sequence databases will help in cannabis DNA fingerprinting, authentication, and measures to increase crop yield and medicinal quality, among other benefits.

  • 10/2019 - Consumer testing technologies are uncovering susceptibility traits that enhance or inhibit the beneficial qualities of cannabis.
  • 1/2020 – Genomic progress is enabling breeders to use genetic information to make informed decisions about cannabinoid production, crop resistance, and other important factors.

Genotype & Chemotype Harmonization

Advancements in genetic and biochemical analyses will help clarify the influence of genetics versus environmental conditions on cannabinoid production. More comprehensive analysis techniques will allow better control and reporting of cannabinoid content – within labs, between operations, and across the industry.

  • 10/2019 - Cannabiniod acids, compounds produced and active in the plant, have been stably isolated and may prove more potent than well-known derivatives, THC and CBD.
  • 11/2019 – The USDA is accepting intellectual property applications for seed-propagated hemp.
  • 12/2019 - The research agency of the USDA is creating the country’s only hemp seed bank with the help of Cornell AgriTech in Geneva, N.Y. With the seed bank, researchers and plant breeders can identify and study hemp varieties that are resistant to pests and diseases. They’ll also be able to develop new types that can adapt to growing conditions specific to an area, like soil type and regional climate.

Product Standards & Labeling

Genetic testing products will continue to help identify microbial contaminants and address food safety concerns, with overall effects on better product standards. Increased quality genetic and biochemical testing will enable complete and transparent product labelling with overall improvements on consumer safety. New analytical tools will allow better delineation between distinct chemovars and strains.

  • 12/2019 - The U.S. Food and Drug Administration has issued warning letters to 15 more companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • 2/2020 Ventures are targeting the underserved market for reliable, clean cannabis plants, leveraging advanced tissue culture and plant breeding technologies.

Quality Control Improvements


Standard Operating Procedures

SOPs will help ensure quality and safety standards are maintained throughout the processing chain and across the industry. SOPs for moisture and pest control may apply to the growth, harvesting, curing, and storage stages. While SOPs for contaminants and potency testing may apply downstream of extraction at the purification and testing stages. Automated monitoring systems will foster SOPs for strain consistency and quality processing standards.

  • 10/2019 - Robotics and machine learning are being implemented to increase speed and accuracy of testing.
  • 11/2019 – New graduate degree programs focus on formalized training in subjects such as standard operating procedures, cannabis tracking, and access management.

Chain of Custody - Seed to Sale

More precise methods for tracking to entire lifecycle of cannabis production are ensuring safety, quality control, and authenticity is preserved. This includes scannable barcodes and electronic data capture (RFID chips) that match specific crop batches with location, operations, and ultimately the end product. Cloud databases store the batch, potency results, contaminants testing, and other data, secured by unique identifiers.

  • 10/2019 - Integrated software services are helping processors exceed stringent standards for ISO accreditation.
  • 11-2019 – Blockchain technologies are improving accountability and visibility for legal cannabis production. Digital platforms are enhancing compliance, point of sale, inventory tracking, and business intelligence data for cannabis dispensaries.

QC & QA Production Guidelines

The harmonization of state guidelines and the advent of federal regulations will enhance the quality of the overall production process. Testing authorities with well-defined procedures and limits will force operations to adhere to quality control and quality assurance measures. Automated and remote systems are enhancing the quality and consistency of cannabis production – at the cultivation, harvesting, and pre-processing stages.

  • 10/2019 - Tests for vaping additives such as vitamin E acetate are being developed to increase product safety.
  • 11/2019 – Technologies are being developed for more precise testing and differentiation of legal hemp versus federally illegal cannabis types
  • 1/2020 – On-site cultivation testing and analysis platforms are enhancing quality control measures for cannabis production.
  • 2/2020The Consumer Brands Assn., formerly known as the Grocery Manufacturers Assn, has formed an advisory board to guide and evolve its role in the burgeoning cannabidiol (CBD) market for consumer packaged goods (CPG).
  • 2/2020 – Certificates of Analysis (COAS) labelling has become a universal quality control measure to support ethical cannabis testing and reporting.

Data Management

Advancements in data management systems are assisting labs, vendors, and consumers by creating more transparency in cannabis product testing. Laboratory Information Management Systems (LIMS) and cloud-based apps are providing streamlined access to information on growth conditions, testing results, chemovar identification and validation, and other areas. Artificial Intelligence (AI) and big data management are enabling optimization of environmental, cultivation, genetics, biosynthesis, and other parameters of cannabis compound production – for instance, optimized yields of CBD produced from legal hemp.

  • 1/2020 – Compliance concerns around hemp and CBD production has led to a number of tracking and audit ready solutions. Systems include assignment of globally unique identifiers to hemp crop lots, database storage of testing data, and audit-ready access to processing and sales details.