The demand for cannabidiol (CBD) finished products has undergone an enormous upsurge in recent years due to increasing awareness of the medicinal benefits CBD may offer. This expansion has enunciated the importance of independent laboratories that play a pivotal role in testing and analyzing CBD products to determine raw material and finished product quality, strength, purity, and label claim. Although several recreational laboratories exist and are capable of performing one-size-fits-all testing to provide a Certificate of Analysis (COA), the absence of harmonized testing standards makes it difficult for a manufacturer and/or brand to know which lab to trust. As a result, CBD manufacturers and brands receive inaccurate or insufficient results, which will not withstand upcoming federal oversight.
To address these common frustrations experienced by stakeholders in the hemp industry, Santé Laboratories opened its doors as the first Contract Development and Manufacturing Organization (CDMO) focused on helping companies commercialize competitive and well-characterized bio-hemp products based on plant extracts, semi-synthetic, and synthetic cannabinoid substances. As a Texas-based company, Santé Labs is the first ISO/IEC 17025:2017-accredited hemp-testing lab in the State of Texas, registered with the Drug Enforcement Agency (DEA), Texas Department of Agriculture (TDA), U.S. Department of Agriculture (USDA), and FDA as a cGMP compliant manufacturer. The company offers a large portfolio of analytical services to help customers with product development, research and development, and commercialization of cannabinoid products and therapeutics. “Our product development philosophy hinges on quality by design (QbD) and regulatory compliance. By helping our customers make decisions through well-designed bench top formulation studies and strong analytical sciences is key to success,” states Mike Sandoval, President at Santé Laboratories.
The company has been trusted by leading CBD brands for its comprehensive, full-service testing services, providing CoAs that follow recommendations by 21 CFR Part 111 for dietary ingredients and finished supplements in anticipation of 2021’s federal regulations.
Traditional full panel testing varies by state; however, test reports commonly include cannabinoid assay (potency) and contaminant screenings. With these regulations, Santé Laboratories anticipates the rise of a “low-dose” market will demand safe, proven, and efficient drug delivery systems enable users to consume “less” without compromising desired efficacy. As a result and for CBD brands that beg to differentiate and successfully transition their “high dose” user base to what regulatory agencies may deem safe, they will be responsible to substantiate chemical and physical stability over time to demonstrate a best by date (shelf-life) and performance.
In anticipation of this maturing market, Santé Laboratories has successfully developed and patented a water-based, surfactant-free, drug delivery system based on nanotechnology rendering CBD and other cannabinoids water-miscible, shelf-stable, and bioavailable when ingested. Santé Laboratories’ expertise was founded on drug delivery and analytical chemistries to develop this nano encapsulated formulation technology for cannabinoid and other active ingredients. Santé Laboratories works closely with brands and manufacturers to future proof their product portfolio with “low dose” water-based CBD formulations in ready-to-use, ready-to-bottle and/or bespoke formulations.
Customizable formulations allow brands to create commercial products faster and deliver better, scientifically-backed products from a cGMP compliant facility. It's important for Santé Laboratories to be a one-stop-shop for all traditional and non-traditional testing services and take products from concept to shelf providing customizable flavor profiles, cannabinoids and cannabinoid concentrations, and preservative systems. Cannabinoid customizations can empower companies to create custom full and broad-spectrum products via the combination of isolates into perfect ratios. All final formulations are backed by shelf-life validation for compliance as well as increased bioavailability proven by a pharmacokinetic study of absorption rates.
With strong industry expertise and understanding of drug development and commercialization, analytical sciences, and regulatory affairs, Santé Laboratories has evolved out of necessity into the only CDMO for the bio-hemp industry today. As a result, Santé Laboratories will continue to scale and diversify its capabilities to service this rapidly maturing market and help others increase likelihood of commercial success. “We understand there is no such thing as ‘one-size-fits-all’ formulation, therefore we don’t deliver ‘one-size-fits-all’ services,” concludes Sandoval.
