Mile High Labs’ Mueller sets CBD standards

LOVELAND and BROOMFIELD — Stephen Mueller of Loveland left the world of engineering to start Mile High Labs Inc. in the new, unregulated industry of CBD products — and after three years of operations, wants that industry to follow stringent quality and compliance standards.

Mile High Labs, a biotechnology company that has a facility in Loveland, paid $18.75 million to purchase Sandoz Inc.’s pharmaceutical manufacturing plant in Broomfield that includes the land, labs, building and equipment. As soon as the deal on the facility closed, Mile High Labs began operations of its private-label CBD products in early October and brought its research, production and headquarters under one roof.

“It was really exciting to come into this space and as an engineer to be able to break new ground, really pioneer this industry, especially in the extraction and purification and manufacturing. … Nobody had done this stuff before,” said Mueller, CEO of Mile High Labs. “We had to invent the technology. We had to build the equipment to do what we wanted to do. We really pioneered the industry and built the process and built the equipment.”

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Mueller, who has a bachelor of science degree in science from the State University of New York at Buffalo, briefly worked in semiconductor research and then in electrical engineering with Agilent Technologies and Teledyne Technologies, where he managed the applications engineering group. He founded his company in 2016 in a 2,000-square-foot lab in Longmont, operating it there for one year before moving to Loveland, where it grew from two to 18 employees.

Mile High Labs started out extracting and purifying CBD ingredients from hemp plants and still sells those as wholesale ingredients. The company wanted to expand into finished products but was limited by its current manufacturing space of 20,000 square feet and began looking for a sizable property. The 400,000-square-foot manufacturing space used by Sandoz had the equipment and infrastructure already in place, including research and development, quality assurance, bottling, filling, packing, warehousing, labeling, shipping and compliance monitoring.

“This has all the clean rooms and infrastructure and equipment and layout that we need to operate that is consistent with our quality values,” Mueller said.

Mile High Labs installed a purified water system and brought in steam, cooling water, nitrogen and compressed air to complete the manufacturing space.

“This was a fully functional plant, and it’s never actually been empty,” Mueller said. “As Sandoz shut down its operations here, we were starting to move in and take over. … We are installing new equipment, and we are modifying some things, but we haven’t really done any new construction per se.”

Mile High Labs now has 234 employees in Colorado, including eight former Sandoz employees, and 22 at the Belfast, London, and Auckland, New Zealand, offices.

“This allows us to really scale up and go after the finished product manufacturing,” Mueller said. “It takes a lot more space to make the finished products because there’s so much packaging and so on.”

The company takes its purified ingredients to manufacture various CBD products, such as tinctures, capsules, tablets, soft gels, gummies and topical products, in addition to creating CBD isolate and distillate ingredients. Its newest product came out in December and will be sold in small batches to test the marketplace.

“We want to supply and make available the highest quality cannabinoid products and make those available to the world,” Mueller said. “Our mission is to bring science and engineering to produce very high quality, consistent products for the global market.”

Mueller sets his company apart by focusing on compliance and quality, but the challenge is working in an industry that is not regulated by the FDA, he said. The government does not regulate facilities where CBD products are produced, nor enforce quality standards, resulting in the industry being self-regulated, he said.

Mile High Labs follows FDA’s regulations of good manufacturing practices in a landscape where most manufacturers lack the level of compliance and adherence to those practices, Mueller said.

“It’s just the right thing to do now, in any case, whether it’s enforced or not,” Mueller said. “Strong, sensible regulation is the only way to protect consumers and create a pathway for the industry to grow.”

Steven Turetsky, managing director of Shi Farms, a national hemp farming cooperative based in Pueblo, sees Mueller as unique to the industry by “doing things the right way.” Shi Farms is one of Mile High Labs’ first customers and an extraction partner, providing hemp that Mile High Labs extracts into various products.

“I look to him as a guiding light for the industry,” Turetsky said, adding that Mueller is a champion of high quality industry and business practices. “He’s pushed the industry to grow up fast. … Quality, transparency and integrity need to keep up, so it’s sustainable. … Stephen had the goal of making a superior product using his expertise. With that comes a greater chance for success, adding his knowledge and skill set to a space that really needed it.”

Mueller would like to see manufacturing practices be enforced, CBD regulated as a dietary supplement and the FDA require new dietary ingredient notifications for product approval (including safety data and processes), he said. He wants products to meet basic level specifications before they are shipped to customers.

“That’s very basic in manufacturing,” Mueller said, adding that quality and food safety systems should be in place “You want to make sure you’re selling what you say you are and you’re not having a contaminated product that potentially could get people sick.”

Mueller also wants to build a company that is sustainable and to educate the public about manufacturing a safe and consistent product. To do this, the company visits chambers of commerce, cannabis organizations and other community groups, presenting various seminars and presentations to explain the challenges and issues in the industry, especially on how to regulate and test the products.

“Without the FDA regulating this industry, it’s up to us to educate the consumers about why they should care about that,” Mueller said. “Our mission is to make sure that we’re providing a safe, quality, consistent product into the market.”