Santé Laboratories
Interview with Mike Sandoval, President of Sante Labs
The Texas Hemp Reporter has partnered with Santé Laboratories and we spoke with Mike Sandoval, President of Santé Laboratories to understand how they have prepared to serve the Texas hemp agriculture community through testing!
Russell @ Texas Hemp Reporter: I’m here with Mike Sandoval, President of Santé Laboratories. Thank you for stepping out of the office and laboratory to talk to me and readers of the Texas Hemp Reporter. Please tell us about Santé Laboratories and provide an overview of your lab services. I’ve been made to understand you built a passionate and talented team and house the world’s best analytical and manufacturing equipment to support your business and customers.
Mike @ Santé Labs: It’s a pleasure to be here today and I’m grateful that we share similar enthusiasm towards the Texas hemp agriculture community. Sante Laboratories is the leading contract development and manufacturing organization to offer contract hemp test services to the agricultural, supplement, and pharmaceutical industry. Over the last 2 years, we developed and commercialize a drug delivery technology to render cannabinoids shelf-stable, bioavailable, and water miscible to address the titanic gap in compliant and retail friendly products. Our persistent focus to raise the bar, leverage good science, and responsibly shape new standards of excellence through hemp testing and product development is something I’m very excited to share with the community. In spirit, ask me whatever questions you have.
_______________________________________________________________
Russell @ Texas Hemp Reporter: What makes Santé Labs so unique? And can you explain to us what testing “Hot” means?
Mike @ Sante Labs: Aside from being the first and largest hemp contract research and testing laboratory in the State of Texas, I believe good science, well-rounded expertise, and meaningful relationships is our differentiator. And that’s pretty much it. It’s absolutely critical to work with a lab that has the experience and expertise of delivering good science and understanding of regulatory requirements to mitigate compliance risks. A partner like us with high level proficiency to ensure test methods and laboratory processes deployed to determine THC and safety on crops was develop and validated according to scientific and regulatory rigor to cover all potential risks and demonstrate to State and federal regulatory authorities that crop test results are valid. Science aside, we build relationships with each of our customers incredibly well. And we put our customer’s need at the center of everything we do, and this begins with providing high quality, traceable testing services, and solutions to overcome challenges. We like to understand challenges and then come up with solutions to address them quickly. Our strengths are science, customer service, and innovation. We spend hundreds of thousands of dollars per year on R&D which includes method development, process optimization, information management, and training to support innovation and thus customer value. We continuously increase testing capacity through procurement of additional equipment to support demand and unique customer needs. We’re a company where innovation is our life blood, and we basically have to innovate and bring stronger sciences and services to the Texas hemp agriculture market to touch and improve lives of our farmers.
Regarding testing “hot” – this means a crop (or finished products for brands) contained more than 0.3% THC, which is the threshold set by State and Federal law. In other words, to be legal, your crop must test at or below 0.3% THC. Challenges are going to be experienced and I encourage farmers to test early and often for THC and build relationships with a professional sampling organization and laboratory. At Sante, we work with the guys at Texas Hemp Samplers. Jacob, Trent, and their team are remarkable, well-informed, and focused to help Texan farmers. Genetics, soil condition, and weather can all impact THC levels therefore like healthcare, preventative care will always be the most beneficial. Good science and strong analytical test methods are required to determine if a crop is “hot” or not.
_______________________________________________________________
Russell @ Texas Hemp Reporter: The TDA and USDA states that hemp testing laboratories are not required to be ISO 17025 accredited, although it is strongly encouraged to adhere to ISO 17025 standards. Where does Santé’ Labs measure on this standard?
Mike @ Sante Labs: At the end of the day it comes down to trust. Customer trust is very important to me and that trust can only be earned through good science and commitment to laboratory quality control procedures and guided decisions to release trustworthy results. Sante is an ISO 17025 accredited laboratory. We were accredited to the 2017 standards compared to 2005 which enacts more rigorous controls to practice risk-based thinking, impartiality, and traceability. Robust workflow traceability with comprehensive audit trails and fully searchable workflows is a must to help ensure data integrity and consistency in the life cycle of every sample that arrives at our laboratory. Look, we’re entrusted by pharmacies and drug companies as well therefore data transparency, traceability, standard operating procedure and documentation is a must and maintaining ISO 17025 accreditation helps us meet these standards. Don’t get me wrong, good science can come from labs without ISO 17025 accreditation, however I encourage customers to think twice about labs that are unwilling to invest into a quality management system to ensure validity of their results. On the flip side, ISO 17025 accredited does not necessarily guarantee high quality testing and certainly does not differentiate a good lab between a bad one. And I’d be happy expand on this topic during our next interview.
______________________________________________________________
Russell @ Texas Hemp Reporter: Can farmers get discounted pricing from Sante if they simply keep using you for all their testing needs?
Mike @ Sante Labs: Yes, we offer a number of packages tailored to all customer architypes. I believe what we do well as an organization is taking time to clearly understand who we serve. In doing so, we developed an appreciation of who our customers are and intimate knowledge base of their testing needs and end goals. Only then can we figure out how to deliver high-value lab testing that can impact their lives. Our customers are so different from one another. The lab tests a farmer versus an extractor may want are not the same. If we get this mixed up or try to offer the same testing panel, both will be dissatisfied. I refuse to titrate to the middle. We must allow those differences to coexist and deliver testing solutions that make the most sense.
_______________________________________________________________
Russell @ Texas Hemp Reporter: What is your opinion of on-site or “on-farm” lab testing? Is this safe and should farmer consider this a viable tool to support pre-compliance tests?
Mike @ Sante Labs: Lab testing, as it may often seem, is not a black-box phenomenon. Pre-compliance and compliance testing are high stakes. To date, I have not identified a company that offers a competitive solution that does not solely rely on economics and ease of use. We rely on proven, data-driven, and tried and true methodologies and fundamental sciences to provide accurate, reproducible, and legally defensible data packages to our customers. There are hundreds of nuances that mobile lab testing or “on-site HPLCs with proprietary software” do not consider that brick-n-motor laboratories do, like Sante. For example, we employ 2 laboratory trained technicians committed to performing daily, weekly, and monthly process and instrument calibration checks. There is an enormous amount of paperwork and manpower needed to preserve traceability and maintain calibrations of critical process steps such as micro balances and pipettors to ensure reliable measurements are made every single day in our lab. We routinely perform installation qualifications, operating qualifications, and preventative maintenance by the manufacture, and in-house performance qualifications to help us to deliver trust-worthy test results. We allocate a substantial amount of capital to ensure all of our equipment is capable of producing legally defensible and most importantly scientifically valid test results that our customers can rely on. Additionally, we have an enormous focus on data integrity and strong workflows. Some of the most common data integrity issues spoke about from regulators relate to the way which electronic data is managed and stored. While on-site labs are appealing and check the boxes of convenience, turn-around time, and reduced sample costs, these benefits are intangible and speculative, in my opinion, an unreliable business model that poses great risk to the end user, at this point in time.
_______________________________________________________________
Russell @ Texas Hemp Reporter: What kind of companies does Sante’ test for now and what range of products do you test for?
Mike@ Sante Labs: Sante Laboratories is a contract development and manufacturing organization for hemp and cannabinoid-based products. In the biopharmaceutical industry, organizations like us are referred to as CROs and/or CDMOs. With that said, we serve majority stake holders in agriculture and finished product value chains by providing access to contract lab testing services. For example, we work with pre/post-harvest hemp biomass to support State and USDA requirements for THC compliance and raw materials analysis to support GxP manufacturing operations. We also have an extensive test portfolio for finished products that includes CBD and other cannabinoids for human use. As many of our customers can confirm, we outperform other labs with difficult and complex matrices such as flower, edibles, and non-traditional drug delivery systems including nanoparticle and novel water-soluble products. Innovation in workflows and developing scientifically sound test methods is a basic customer right and it’s something we love to commit time towards. Through countless conferences and lengthy and often emotional discussions with customers, we’ve been made to understand strong science, innovation, and attention to detail is what the hemp industry needs. Regardless of what everyone thinks, whatever the hemp testing market is or may become, innovation and forward-thinking science must be customer led.
_______________________________________________________________
Russell @ Texas Hemp Reporter: Can you talk about label compliance?
Mike @ Sante Labs: Its more appropriate to speak about label compliance when referring to finished goods such as CBD supplements. As you know, until the FDA renders CBD finished products as dietary supplements, there are minimal regulations to enforce expiration date claims. There are a number of class action lawsuits against CBD consumer brands that failed to substantiate shelf-life and safety claims that puts the industry at risk. We can help. Sante labs has the capacity to determine stability of CBD and/or other active ingredients in supplements and therefore the shelf-life of a product. Shelf-life is not an end all be all for a product to be considered “compliant”. Product and formulation safety and accurate label claims are so important, and this disregard keep me up at night. This is why we Sante is pleased to offer a number of CMC considerations which includes chemistry, manufacturing, and controls to develop high quality products. I look forward to going into more depth on this topic on the next issue.
_______________________________________________________________
Russell @ Texas Hemp Reporter: Can you explain to the readers how you measure total delta-9 tetrahydrocannabinol (D9-THC) concentration levels in their crop?
Mike @ Sante Labs: At Sante, we use Ultra High-Pressure Liquid Chromatography (UHPLC) systems coupled with diode-array detectors for unmatched limit of quantification and simultaneous detection of cannabinoids including d9-THC. We also have mass spectrometers in tandem for customers that reside in certain States that require mass confirmation of cannabinoids. Liquid chromatography is a robust and proven platform for detection of drugs including cannabinoids in the pharmaceutical and hemp industry. To quantify THC in samples, we developed and validated highly efficient extraction processes to yield analytical consistency and repeatability. We only purchase certified reference material (we call these CRMs) from ISO 17034 qualified suppliers that meet our internal quality specification. Test results are only as accurate as CRMs used to quantitate customer cannabinoid and non-cannabinoid test results. Knowing this, we allocated capital into cold chain storage and 6 place analytical balances to responsibly handle all CRMs. In my opinion, this is why on-site lab business models or “off the shelf” in-house equipment suppliers experience inadequacy after factoring in all the nuances a high-quality laboratory must embrace.
_______________________________________________________________
Russell @ Texas Hemp Reporter: What is the best way to contact you and Sante Labs for testing services?
Mike @ Sante Labs: My team and I are readily accessible by email, phone, and through the website. I’m excited to announce that we successfully implemented an API onto the website to give our customers direct access to our calendars to schedule meetings on-demand. Most of us work flexible and long hours to deliver value to our domestic and international customers so I’m confident we can accommodate nearly all schedules. I look forward to speak with new and existing customers and be a resource however that may be.
_______________________________________________________________
Russell @ Texas Hemp Reporter: What the heck is U = K *uc?
Mike @ Sante Labs: (Laughter). It’s a confusing and overwhelming equation. Ok, give me some rope here… U stands for measurement of uncertainty, k stands for coverage factor, and uc is combined uncertainty that factors in repeatability, reproducibility, and accuracy uncertainty. To put simply, U, or measurement of uncertainty is the “give or take” or “error” of a specific test a laboratory performs. All measurements have error and the same is true for every item such as rulers, compasses, thermometers, and volume decibels on a television. Measurement of uncertainty is extraordinarily important for a laboratory to understand as the relationship between precision of an analytical test method (total THC) and its measurement variability is directly proportional to the concentration at which the analyte (or THC) is being quantified. There is generally more uncertainty and variability in measurements when testing for trace levels. This is particularly apparent when testing residual pesticides, which is why labs are forced to purchase $350k mass spectrometers to do it right. The same is true when testing for 0.3% THC. The difference between 0.3% THC and 0.32% THC is legal vs. illegal. This is why we invested into the best analytical equipment and employ the brightest minds to produce the most repeatable and defendable results with the lowest reported error. No shortcuts were made. The USDA and the Texas Agriculture Department requires all laboratories that analyze hemp for THC compliance to report measurement uncertainty. This is a regulatory requirement and labs should have internal documentation to support the claimed uncertainty. I’m proud to report that Sante has the lowest and most defensible measurement of uncertainty for THC which gives our customers peace of mind and edge to compete in this space.
_______________________________________________________________
Russell @ Texas Hemp Reporter: Any final thoughts to fans of hemp and Texas farmers Texas?
Mike @ Sante Labs: Don’t give up, have faith in the system, be patient with labs and regulators, and do due diligence on whom you choose to work with. This applies to the lab you choose as well. Texas farmers that we work with today are some of the most resilient, humble, and intelligent people we’ve had the opportunity to meet – and I want them to learn from mistake of others rather than making their own. The Texas hemp industry is new, and we have incredible leadership working hard to ensure the success of all stakeholders. However, there is much we do not know, and good science and responsible regulations take time. I’m a firm believer if we’re going to succeed as an industry, we must have that pervasiveness in everything we do. My advice…build meaningful relationships with everyone you work with, openly communicate, and collaborate. Your success is our success and vice versa.
_________________________________________________________________________
Russell @ Texas Hemp Reporter: Mike, thank you for talking with us this month. I look forward to following up with you in a few months and learn how you and Santé Labs have taken care of Texas farmers.
Mike @ Sante Labs: Russell, thank you. Look, the Texas agriculture economy will lead the United States hemp market, and it will all begin with testing. And access to strong science and dependable lab results will be a big part of winning this in the end, and we’re absolutely committed to making that happen. Many farmers we work with today are personal friends of ours, and I admire them a lot. Just like many of our other customers. And I look forward to serving them to our fullest potential.