Testing & Processing Formulation, Cannabinoid analysis, Potency testing

Firm Foundations

With a background in researching cancer and brewing beer, Andrea Baillo (Green Thumb Industries) hit a hot topic with her 2020 Emerald Conference talk on stability testing. We caught up with her after the show to dig into shelf lives, regulatory challenges, and technology tips.

05/27/2020 | Interview

Yes, I started out in cancer research, but it was tough to find grant funding in the aftermath of the 2007 financial crash. So when an opportunity arose to work in QA/QC for a brewery, I decided to give it a try. I learned a lot about manufacturing, production, and quality management in the brewing industry, but I was keen to start using my hard-won laboratory skills again, so I was delighted to join Green Thumb Industries as Director of R&D and Quality. The cannabis industry was particularly appealing to me because there’s so much left to discover. The industry is evolving at breakneck speed and I thrive on change!

There are two sides to my role. First, I help design and formulate new products; at the moment, we’re doing a lot in topicals and edibles. Second, I make sure that we are producing high-quality, consistent products by looking at the technology and methods we use in all areas of the business, from cultivation to drug delivery.

A fun project we worked on recently was creating a new transdermal product line. It was great to have an opportunity to engineer a product to deliver cannabinoids through the skin and then prove it using the classic tape strip experiments used to test suncream and other consumer products.

First and foremost, the variation in regulatory standards between states here in the USA. For those of us who serve multiple states, it’s a real problem. One state may only allow ingredients on the FDA inactive list, whereas another might have minimal restrictions on ingredients; some states have very low limits on solvents, while others are more realistic. You end up having to make different formulations for different states, which makes supply chains very complicated. Then there is the added issue that moving products across state lines is very difficult – so you need a full suite of production and testing equipment in every state.

Finally, there can be a lack of scientific understanding in the field. In particular, I’ve noticed that a lot of people working in cannabis don’t have the funds to access scientific journal articles, or the skills to scrutinize them. Instead, they just read the abstracts and accept the conclusions unquestioningly – or don’t search the literature at all. And that’s a shame because there is a great deal of pharmacology research that is very relevant to the industry.

Historically, not that much attention has been paid to stability within the industry. Cannabis products are given an expiration date but there has been very little underlying research. Interest has increased in the wake of the epidemic of vaping-related lung disease last year – it has opened people’s eyes to the fact that one wrong ingredient could have terrible consequences down the road, so companies want to be sure their products are safe and effective in the long term.

Maryland takes stability seriously, and mandates the maintenance of a retention library. I thought, why not make our own library alongside the state library? In our library, we now save 30 samples of each product type, allowing us to make multiple measurements over time. We can measure many different aspects of stability: therapeutic (persistence of cannabinoids and terpenes), emulsification, rheology, water activity, water content, chemical modification (for example, oxidation), microbiology, and toxicology (for example, heavy metals leaching from packaging).

We bought incubators to accelerate degradation and allow us to collect more data. We’re using this information to monitor the safety and shelf life of our products, and, where possible, tweak the formulation to make it last longer. Now we’re developing reports that we can share with the wider industry.

We were surprised that compressed tablets tend to have lower stability than other products – possibly because we are giving the cannabis a higher surface area, so it’s more exposed to oxygen.

One relatively inexpensive piece of equipment I would recommend to every cannabis lab is a water activity meter. There’s no intrinsic property more important than water activity in predicting the survival of microorganisms in food products. It worries me to think that some labs might be scrimping on microbiological testing; it would only take a few consumers to become ill and a lot of the progress made to destigmatize the plant could be undone.

If you want to go a step further, near-infrared spectroscopy is an excellent tool for analyzing the major constituents in your product and raw materials.

I’ve got granulation technologies (to allow for more precise dosing) and flash chromatography (to improve cannabinoid separations) on my wish list. Oh – and automated systems to improve speed and consistency.

My favorite presentation was Jerry King talking about the physicochemical properties of cannabis constituents. He emphasized that the answers are often out there already in other areas of science, and you just need to look for them. That point really resonated with me!

This article is part of a series of interviews with selected speakers at the 2020 Emerald Conference. Other experts sharing their California dreams (and nightmares!) include: