Working in Cannabis

By Daniel Kulakowski, PhD

If you would like to work with one of the most widely used plant medicines in the country and enjoy the opportunity to directly impact patient health and product development, I recommend pursuing a career in the cannabis industry. There are several ways scientists with a pharmacognosy background can get involved in the field.

I am a lab director at an independent testing laboratory (ITL) in Maryland, Steep Hill, Inc. Most states with a medical or adult-use program require third-party product testing for safety and potency. ITLs provide potency and terpene data that eventually gets listed on product labels. This information helps patients and dispensary employees choose and recommend medicines. In many states ITLs also ensure product is free from pesticide, solvents, metals or microbial contamination.

Typical analytical methods involve HPLC-PDA and GC-MS/FID for cannabinoids and terpenes, LC-MS and GC-MS for mycotoxins and pesticides, GC-FID for residual solvents and inductively-coupled plasma (ICP-MS) for heavy metals. While the ICP-MS is a tool not often employed in pharmacognosy labs, it has been fun and interesting to learn sample preparation and analysis for inorganic analytes.

I transitioned from an academic lab environment to a production lab and at first was worried about accreditation to an ISO17025 standard. I had been warned about burdensome documentation and rigid practices that come from working in an accredited lab. This was an initial culture shock, but now that a quality control system is in place the process of implementing new methods, improving old methods or installing new equipment is quite efficient. Better yet, the associated validation and verification steps ensure that method changes and new equipment actually improve or maintain the quality and reliability of data produced in the lab.

There is currently a lack of standard analytical methods for cannabis which increases the validation burden for internally-developed methods. Standard methods are beginning to be developed by ACS and AOCS, but a challenge to their development has been the lack of a standardized cannabis product that can be tested and compared in labs across the country.

Cannabis is currently still a schedule I drug and cannot be transferred across state lines, even between two states such as Maryland and Pennsylvania which both have legal medical programs and a shared border. Despite this regulation, certified reference standards for THC and other cannabinoids are commercially available but must be kept below the DEA limit of 0.3% (w/w).

Cannabis testing regulations also differ among states. The specific pesticide, heavy metal and residual solvent panels a lab is required to test for, as well as the action limits for each analyte, are set by regulators in each state’s program. Specific state requirements influence the type of equipment that can be used for testing. For example, a 1000 ppb action limit for certain pesticides may be easily achievable using GC-MS, but 100 ppb limit will require a LC-MS.

There is currently a lack of standard analytical methods for cannabis which increases the validation burden for internally-developed methods.

Quick turnaround times, immediate implementation of new state regulations and reproducibility among lab staff are all challenges of working in an ITL. This fast pace, combined with the opportunity for optimization and building efficiencies, keep the job interesting.

In addition to employment with an ITL, chemists can find work with growers and processors or regulatory bodies. Growers and processors need scientists who can understand and optimize cannabis extraction (often propane, butane, ethanol or supercritical CO₂) or conduct in-house R&D projects, such as formulating new products, optimizing harvest time or drying conditions, or conducting stability studies. Cannabinoids and terpenes are often the focus of internal R&D projects, but testing of soil, inputs or plants for heavy metals, mycotoxins, pesticides and other contaminants may also be desired to ensure product safety.

State cannabis commissions, the regulatory bodies in charge of implementing and enforcing cannabis programs, need individuals with a chemistry background to understand, translate and implement policies that make sense for patients, growers and processors.

The relatively small size of labs and cultivation and processing companies can place chemists one step away from patients. If my lab fails a product due to contamination, a patient will not have access to a potentially compromising product. If a pharmacognosist working at an extraction facility formulates a new tablet, it has the potential to be in a patient’s hands in weeks. The opportunity to impact patient health so directly brings with it a strong sense of responsibility and excitement.

State cannabis commissions, the regulatory bodies in charge of implementing and enforcing cannabis programs, need individuals with a chemistry background to understand, translate and implement policies that make sense for patients, growers and processors.

In the short-term future I believe more pharmacognosists across the industry will push the cannabis field forward. New cannabinoid and terpene extraction techniques will be necessary to continue to produce unique, differentiated products. Flash chromatography and liquid-liquid chromatography have a lot of potential but are not frequently used. Formulating cannabis with other herbs could also be a benefit to medical patients.

There will also be more opportunities for academic cannabis research. Even this past spring the NIH put out four RFPs for cannabinoid- and terpene-based research. Academic cannabis programs in the US are starting to take off, such as the UCLA Cannabis Research Initiative, the Institute of Cannabis Research at Colorado State University-Pueblo and the Master of Science Program in Medical Cannabis Science and Therapeutics at the University of Maryland School of Pharmacy.

This fast pace, combined with the opportunity for optimization and building efficiencies, keep the job interesting.

 

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