Establishing an In-House Laboratory


In this Growers Spotlight, we interview Kevin McKernan of Medicinal Genomics about the benefits of establishing an in-house testing laboratory for your cannabusiness.

Kevin McKernan

The following is an interview with industry experts. Growers Network does not endorse nor evaluate the claims of our interviewees, nor do they influence our editorial process. We thank our interviewees for their time and effort so we can continue our exclusive Growers Spotlight service.


Abbreviated Article


Editor’s Note: Growers Network appreciates its readers! If you are limited on time, we are now offering abbreviated versions of our articles. Click below to view.


Establishing an In-House Laboratory



Why should growers build an in-house laboratory?

First and foremost, you shouldn’t focus on doing third-party laboratory work because you will always need them for conflict-of-interest reasons. Instead, you should focus on the multiple additional benefits an in-house laboratory can provide:

  1. Establish an internal QA.
  2. Test products before they enter packaging.
  3. Test for things that third-party testing laboratories don’t. For example:
    1. Find out if your seeds are feminized
    2. Early detection of potential pathogens
    3. Find microbes in your soil and on your leaves.


What are some reasonable things to build an in-house laboratory for?

Building a complete lab that could test everything would around $1.5 million, which isn’t necessary for most operations. Instead, focus on the tests that what will give you the biggest bang for your buck:


Genetic Testing

Genetic testing will probably give you a good ROI. You can test for pests, aid your breeding program, and spot potential problems early on. These tests can also help prevent crop loss, which has a very heavy cost for grows.


Cannabinoids Testing

Cannabinoid testing is more expensive than genetics tests, but it has a good ROI as well. You’ll generally need an HPLC machine and technician to test for cannabinoids. Models vary in price from $10,000 to $100,000, depending on the model.


Heavy Metals

Testing for heavy metals provides a relatively low ROI. You should only pursue this if you’re a large company that wants to streamline your QA.


Pesticides

Testing for pesticides is extremely expensive and has a very low ROI for growers. You should already know what’s gone into your plant.



What are some different uses for an in-house lab?

  1. Test mothers for pathogens before cloning.
  2. Determine seed sex.
  3. Discover pathogens while they’re dormant.
  4. Speed up your breeding programs.

Cannabis is still a relatively young industry. As rules and regulations change, an in-house laboratory may keep your operation compliant. In the long run, a genetics laboratory can help you identify genes useful for your breeding programs.



What would I need to start an in-house laboratory?


General Equipment

At minimum, you will need:

  1. A lab bench
  2. Pipetters and pipette tips
  3. A mixer/vortexer
  4. Any necessary reagents
  5. Test tubes, gloves, cotton swabs, and forceps
  6. And any tools related to the tests you’d like to perform.


Personnel

The personnel you will need will depend on the tests you are looking to perform. Simpler tests will require a person with a Bachelor’s degree in microbiology or a related field. More complicated tests will probably need somebody with a Master’s degree in chemistry.



If I’m managing an operation, how does an in-house laboratory affect my bottom line?

If you’re a small operation, an in-house lab can be a huge burden and may not be worth the cost. However, if you’re a mid to large sized operation, the cost will be relatively minor compared to what it could save you. The average cannabis plant is worth about $650 to grow operations and when you’re growing thousands of plants, a pest incident could cost you a fortune. A laboratory is like your own insurance policy, protecting you from potentially catastrophic losses.



What kinds of standards are there for cannabis labs?

There’s two big ones, depending on where you’re located:

The AHP or American Herbal Pharmacopeia puts out standard monograms detailing information about cannabis. The AHP recommends six standard tests for third-party labs:

  1. E. Coli
  2. Salmonella
  3. Enterobacteria
  4. Coliform Bacteria
  5. Total Yeast/Mold
  6. Total Bacterial Count

The EHP is the European Herbal Pharmacopeia. Europeans and Canadians follow this. The EHP recommends the same tests as the AHP, plus two more:

  1. Pseudomonas aeruginosa
  2. Staphylococcus aureus

Both of these standards are only concerned about human pathogens, and an in-house laboratory can fill the gap.



Tell me about your company.

Medicinal Genomics offers many services, including:

  1. Genetic tests for human pathogens in grows
  2. Genetic tests for plant pathogens in grows
  3. DNA sequencing for strains, for the following purposes:
    1. Defensive Intellectual Property Patents
    2. Tracking and Identification
  4. Other genetic consulting services. Check out our website to learn more!

If you like the abbreviated article, let us know in the survey at the bottom of the article! We’re always interested in hearing your feedback.

If you want to read more, you can read the full article below.


Why start a lab?


We should probably address the elephant in the room first. When a grower or dispensary builds an in-house laboratory, they shouldn’t focus on doing third-party laboratory work. For conflict-of-interest reasons, third party testing labs will always exist, and growers and dispensaries will always need to use their services for legal reasons.

Remember that third-party labs only test the finished products. They don’t test seedlings or clones for potential problems, and they generally don’t analyze information that breeders find relevant early on in a plant’s life cycle.

Instead, we should focus on the multiple additional benefits an in-house laboratory can provide:

  1. Currently, many growers feel like they’re playing Russian roulette when they submit samples to testing laboratories. With an in-house laboratory, growers can reduce or eliminate that fear altogether.
  2. If your company is focused on building a high-end brand, in-house laboratories can set a quality assurance (QA) bar for the entire company, making it stand out from its competitors.
  3. In-house testing can save money by performing tests before products go into packaging. Normally, if a test from a third party comes back with bad results, the entire batch may need to be unpackaged and tested more thoroughly. Having an in-house laboratory test products before they enter the package can save a lot in packaging costs.
  4. Third-party testing laboratories aren’t obligated to test for certain things that might be relevant to a grower. Third-party labs mainly test for things that are of concern to the end consumer, not the grower. For example:
  5. Uncertain if your seeds are feminized? Why not test them early on and save yourself the headache of growing males all the way to flowering?
  6. Want to look for potential pathogens before they become a problem? You can detect things like Mosaic viruses, which aren’t harmful to consumers at all, but could endanger a grow.
As you’re probably aware, testing equipment can be really expensive. If you were to try and build a complete lab that could test everything, you would probably spend around $1.5 million, which isn’t feasible or necessary for most operations. Instead, you should focus on the tests that what will give you the biggest bang for your buck. Below are different kinds of tests in order of usefulness per dollar spent:



Genetic Testing


Genetic testing is actually much cheaper and simpler than many people think it is. Not only are services for humans like 23andme becoming increasingly common and cheap, but similar services are also appearing for horticultural companies.

Genetic tests will probably give you the biggest ROI. The information you can learn from them is incredible, and the cost is relatively miniscule compared to what you could lose from not knowing. You can test for pests, help out your breeding program, and look for potential problems that might appear in third party tests.

Soil sampling and leaf sampling is relatively cheap and easy.

For example, Medicinal Genomics has developed a USB-powered PCR device that only costs about $500. It can run about 8 wells at any given time, which isn’t a huge amount, but sufficient for a small grow. This little device can test for different microbes in soil, on leaves, and elsewhere. This information can be extremely helpful to a grower looking to eliminate pests and increase beneficials. These tests can also help prevent crop loss, which has a very heavy cost for grows.



Cannabinoids Testing


Testing for cannabinoids is relatively cheap. However, cannabinoid testing is significantly more expensive than many genetics tests. Knowing your cannabinoid content can really help boost sales and product prices or improve your breeding programs, thus it has a good ROI.

Generally speaking, you’ll need a high performance liquid chromatography (HPLC) machine to test for cannabinoids. These can run around anywhere $10,000 for your basic models, up to $100,000 for very advanced models. You’ll also need a technician trained in using this equipment to run your tests.



Heavy Metals


If you want to test for heavy metals, you’re looking at a relatively low ROI. The main reason you’d want to perform heavy metal testing is that you’re a sufficiently large company that wants to streamline their QA and testing with third-party labs.

In order to set up a lab to test for heavy metals, you’ll likely need an ICP-MS machine or GC-MS machine, which will run you around $30-50 thousands. You will also need a technician to operate these machines.



Pesticides


Testing for pesticides is extremely expensive and probably has a very low ROI for growers. If you’re a good grower, you should already know what’s gone into your plant, and this test shouldn’t be necessary for an in-house laboratory. Third party labs usually test for pesticides anyway.

An Agilent Triple Quadrupole LC/MS system.

However, if you are still interested in testing for pesticides in-house, you’re looking at buying a Triple Quad, abbreviated as TQ-MS, which often costs hundreds of thousands of dollars. You’ll also likely need a Ph.D or an experienced Masters degree to operate the machine.


You can test a mother for any pathogens before cloning.

If you clone a mother that’s hiding spores or holding a pathogen, you can end up with a nightmare scenario and a lot of wasted time and effort. You can test your mothers before cloning to ensure you don’t waste time or energy.


You can test whether seeds are male or female.

This will save you a significant amount of time and effort that might have been wasted raising a male plant all the way to flowering. Save yourself some time and money in your breeding program!


You can test for pathogens before entering flowering.

Powdery mildew takes a month and a half to incubate in a host plant before it begins expressing itself. Because it grows within the host plant, it is a systemic pest.

Typically powdery mildew expresses itself when a cannabis plant transitions into the flowering stage. By testing plants before they enter flowering, you can catch powdery mildew while it’s in its dormant stage and quarantine affected plants, potentially saving many crops as well as reducing your sanitation needs.


You can speed up your breeding programs.

You can look for desirable genes in your breeding programs and select for those traits. This can lead to an accelerated breeding program that you may be able to file patents for in the future.

One thing worth consideration is that cannabis is still a relatively young industry. As rules and regulations change, an in-house laboratory may act as a buffer to keep your operation compliant. For example, recent papers have highlighted a number of dangerous compounds that plants can produce. With a lab, you could relatively easily detect if a strain could produce these compounds and avoid a legal headache, should these compounds get banned.

Saving you headaches.

In the long run, a genetics laboratory can help you identify genes for resistance to certain pathogens. By incorporating these genes into your breeding programs, you can make stronger, hardier strains that make your operation more secure.


How do I start a Lab?




General Equipment


A general laboratory set up will probably cost around $1500 plus whatever space you need to install it. At minimum, you will need:

  1. A lab bench
  2. Pipetters and pipette tips
  3. A mixer/vortexer
  4. Any necessary reagents
  5. Test tubes, gloves, cotton swabs, and forceps
  6. And any tools related to the tests you’d like to perform.


Personnel


The personnel you will need will depend on the tests you are looking to perform. If you’re doing microbiological screens, a person with a Bachelor’s degree in microbiology or a related field will probably suffice. For genetic tests, most people with Bachelor’s degrees in genetics or biology will be sufficient. As long as they have experience performing simple assays, pipetting, and tissue sampling, you shouldn’t have too many difficulties.

All lab personnel should be familiar with the use of pipettes.

However, for some of your more complicated tests, such as cannabinoids, heavy metals, or pesticides, you will probably need somebody with a Master’s degree in chemistry. As the equipment becomes more expensive, so too will the training necessary to operate the equipment increase.

Obviously you have your initial setup costs and employee salaries to contend with. If you’re a small operation, this can be a huge burden and may not be worth the cost. However, if you’re a mid to large sized operation, these will be relatively minor burdens compared to what they could save you.

For example, because you can test whether seeds are male or female, you can save any breeding program you’re running a lot of time and space by only selecting female seeds. You can also screen out potential pathogens before they would ever become a problem, saving you a massive headache and a lot of time and money. There’s huge value in preventative savings.

During the course of my research, I’ve found that the average cannabis plant is worth about $650 to grow operations. If you’re growing hundreds or even thousands of these plants, a pest-related incident can cost you thousands upon thousands of dollars. A laboratory is almost like your own insurance policy, protecting you from potentially catastrophic losses. It may not catch everything, but it will probably save you more money than it will cost you.

It really depends on what your goals are for the laboratory.

If you’re establishing the lab for internal quality control, then the lab’s management will be contingent on the production manager for your grow operation. The production manager will need to inform the laboratory technicians when and where their services are required. You’ll also need to identify problems in your quality process and figure out how to test for them.

If you’re looking to start testing for potential pathogens with genetic tests, you will likely not need much in the way of supervision. A procedure should be set forth for the employee(s) that they sample a certain amount of soil/leaves/stems/etc., periodically, from different locations around the grow.

Organelles moving in a plant.

And if you’re interested in breeding, you’ll likely need a few employees, including a laboratory supervisor. The lab workers will be responsible for most of the testing, and the supervisor will need to compare genotypes and phenotypes and submit reports regularly to the breeders.

Now, bear in mind that in-house laboratories don’t need to go through the accreditation process. That’s only if you want to become a third party laboratory. However, most in-house labs try to stick to the standards that third party labs follow.

While I don’t want to be too advertorial, I should mention that Medicinal Genomics is available for consulting operations that are looking to establish in-house laboratories. There are also other testing services that may be interested in consulting as well.

Editor’s Note: A similar company named Marigene may be interested in consulting.


Other Considerations

I think the way cannabis testing is regulated currently is out of alignment from what it should be.Kevin McKernan
There’s two big ones, depending on where you’re located:

The AHP, or American Herbal Pharmacopeia, is an American organization that puts out standard monograms detailing information about cannabis and other herbs. The AHP recommends six standard tests (the “six-pack”) for third-party labs:

  1. E. Coli
  2. Salmonella
  3. Enterobacteria
  4. Coliform Bacteria
  5. Total Yeast/Mold
  6. Total Bacterial Count

The EHP, on the other hand, is the European Herbal Pharmacopeia. Naturally, if you’re in Europe, this is what you follow. If you’re located in Canada, you also follow the EHP. The EHP recommends the same tests as the AHP, plus two more for specific human pathogens:

  1. Pseudomonas aeruginosa
  2. Staphylococcus aureus

Both of these standards are concerned about human pathogens. If a consumer tries your product, you don’t want the consumer to get sick. However, both of these standards pay no attention to plant pathogens. If you’ve got spider mites, they’re not in these tests! And that’s where an in-house laboratory can fill the gap.

In my personal opinion, Oregon actually has some of the most lax guidelines when it comes to testing their cannabis. The reality is that their tests aren’t looking specifically for harmful microbes, instead choosing to look at overall microbe counts. This means that any beneficial or otherwise neutral microbe can cause an “unacceptable” result, despite being perfectly safe.

SEM of Staphylococcus Aureus

In my opinion, these kinds of total bacteria and total yeast/mold tests need to be done away with in favor of pathogen-specific tests. For example, there was a recent case of a patient in Canada who suffered a serious infection after trying some cannabis. After a biopsy, it turned out that there was parasitic fragilis in the cannabis. For most people, fragilis is relatively benign. But in immunocompromised patients like this one, it can be potentially lethal. Current testing protocols in Oregon will likely miss this pathogen.

I personally think that California is taking a rational approach to laboratory testing. They appear to be designing legislation that tests for specific harmful pests and pathogens in cannabis, rather than relying on blanket tests.

One other thing I want to mention is that I think the way cannabis testing is regulated currently is out of alignment from what it should be. Testing for THC and CBD is nice and all, but at the end of the day, it doesn’t impact consumer safety. It shouldn’t be as big of a testing priority as it is. We need to test for the things that will hurt consumers.

A few different things:

  1. Accelerated breeding programs that are inspired by genetic testing.
  2. Robotics and automation! We’re seeing the cutting edge of it emerge now. However, automated sampling and testing is right around the corner.
  3. Lower costs. As cannabis emerges from the shadows, businesses will start to invest more into R&D, which in turn will lower costs for laboratory equipment and tests.

About the Interviewee


Medicinal Genomics uses its unmatched expertise in cannabis genetics to develop testing technologies that help growers, dispensaries, and testing laboratories ensure patients and consumers have access to safety, quality cannabis.

Originally, I had no interest in the cannabis industry. Instead, I was interested in genetics. I graduated from Emory University in 1995 with my degree in Biology, and I started my career with the Human Genome Project in 1996. I was eventually promoted to be the manager of an R&D Unit, and I learned a lot during that time before I left in 2000 to start a spin-off company.

During my time sequencing patients, I noticed that polymorphisms in cannabinoid receptors strongly correlated with frequent migraines and the onset of certain diseases.

I started a company called Agincourt in 2000, which has since been acquired by Applied Biosystems, a subsidiary of Thermo Fisher Scientific, in 2005. While I worked with Agincourt, I helped to develop a new DNA sequencer that was used to sequence tumors.

After my work with Agincourt, I moved onto a company called TGen, which sequences patients with cancer. While I was working there, patients started to ask questions about using cannabinoids to treat cancer. I had to admit to them that I had no knowledge about their pharmacological effects at the time, but eventually the questions kept coming. I decided to take a dive into the literature about cannabinoids, and I was amazed at what I found.

I realized that nobody had fully sequenced cannabis, and I was shocked. I quit my job with TGen in 2011 and started Medicinal Genomics. During my first year, I sequenced chemdawg, one of the more popular strains available at the time. Unfortunately, due to legal concerns at the time, I had to put Medicinal Genomics on ice until the Cole Memo in 2013 came around.

During the intervening time, I started Courtagen, a company that sequenced patients for doctors. Since there was no issue with the legality of sequencing patients, Courtagen proved to be very successful. During my time sequencing patients, I noticed that polymorphisms in cannabinoid receptors strongly correlated with frequent migraines and the onset of certain diseases.

Around 2015, the cannabis market really started to take shape with increased legalization. This is when I was finally able to take Medicinal Genomics off ice and invest into it. We started by making microbial testing kits to test for the presence of harmful microbes. We also started working with breeders to improve breeding programs using genetics.

Medicinal Genomics was the holding company for Courtagen. Because the healthcare market is looking significantly less stable with the current political climate, I felt that it was time to move onto the (apparently) more stable cannabis industry with Medicinal Genomics. I discontinued Courtagen recently to focus exclusively on Medicinal Genomics.

Medicinal Genomics offers many services, including:


Genetic tests for human pathogens in grows

These are primarily sold to third-party testing labs, although larger grows are starting to integrate these tests into their QA. As the industry starts to mature, we’ll see more of these QA go to producers.


Genetic tests for plant pathogens in grows

These tests are designed for grows that are worried about powdery mildew, russet mites, botrytis, and more. They’re useful for screening plants in quarantine before they enter the main grow, as well as identifying potential problems before you can even see them.


DNA sequencing for strains

This is where we see a very large future market, although we’re not entirely sure what direction it will go. Right now, we see two avenues emerging for strain sequencing:

  1. Defensive Intellectual Property Patents
    1. Cannabis patents are starting to pop up with increasing frequency nowadays. Strains that were once believed to be public domain are becoming protected IP, through the prior-use condition of patent law. Additionally, because of international copyright agreements, the USA has to respect copyrights on cannabis strains from other nations, despite their lack of legality here.
    2. These kinds of sequences are very thorough, and often involve looking at several hundred markers, if not sequencing the whole genome. As a result, these kinds of tests tend to be more expensive and less common, but they may show up with increasing frequency in the years to come, and will be useful in court cases surrounding intellectual property rights.
  2. Shorter, faster sequences to track and identify strains
    1. Many grows and dispensaries want to be able to ID their plants with 100% certainty. We’re finding that strains like Skywalker OG in one place are in fact labeled as a different strain elsewhere, and many plants are improperly labeled. Sequencing that looks for specific markers in the plant will be able to prevent a lot of this kind of confusion.
    2. Additionally, many companies are looking to integrate their Seed-to-Sale tracking systems with genetic tests. This will improve their sales and marketing tactics, as well as reliability.
    3. We may see regulators and law enforcement use these kinds of tests in the future to make sure companies are being honest and transparent.

Currently, we serve both services, but each one has its own specific needs.

Definitely! We run a yearly conference around the science of cannabis, called CannMed. We’re always happy to have more businesses to join in the conversation.

One other thing is that we want to hear from growers. What are your pain points? What are some pests we could design tests for? We are aware of some of the more common pests, such as spider mites, Botrytis, powdery mildew, etc. but are there any pests you’d like to see tests for? Reach out to us.

If you want to reach me, you can try our company email at [email protected], or contact my email directly at [email protected].



Do you want to receive the next Grower’s Spotlight as soon as it’s available? Sign up below!


Want to get in touch with Medicinal Genomics?

You can reach them via the following methods:

  1. Website: http://www.medicinalgenomics.com/
  2. Phone: 866-574-3582
  3. Email: [email protected] or [email protected]

Resources:

  1. Interested in learning about growing protocols that can help prevent the spread of pathogens? Check out our article on Integrated Pest Management.
  2. Control your environments to prevent pathogenesis! Read more about VPD for Cannabis Cultivation.
  3. Want to protect your grow from loss? Learn about Cannabis Business Insurance.

Do you have any questions or comments?

Feel free to post below!


About the Author

Hunter Wilson is a community builder with Growers Network. He graduated from the University of Arizona in 2011 with a Masters in Teaching and in 2007 with a Bachelors in Biology.


  • Mark Esau

    GC/MS (gas chromatography with mass spec detection) is not used for measuring the presence of heavy metals. It is used to analyze the volatile components of an extract sample such as terpenes and terpenoids and is used to verify that extract products do not contain residual extraction solvent (residual solvent analysis). Ion-coupled plasma (ICP), X-ray Fluorescence (XRF) and Atomic Absorption (AA) are analytical methods used to measure trace metal contaminants in samples.