ISO certification for Boone-based startup MOLTOX now a done deal

BOONE – Sometimes it’s the thought that counts.

That was the case with Boone-based manufacturing research company MOLTOX Molecular Toxicology, Inc., which produces pre-clinical research products for toxicology testing.

“Our goal for a long time has been to seek ISO (International Organization for Standardization) 9001:2015 certification,” said company President Kristen Rundell. “We thought about it for years, and now we’ve done it.”

The family-owned company achieved the certification in November 2022 following a 12-month exercise that closely examined all its quality processes. The oddly abbreviated ISO program standards are designed to help companies ensure the quality, safety and efficiency of their products, services and systems.

“All our processes were already in place, and we had to make very few changes to gain certification, which was great,” Rundell said. “We’ve been operating and living as if we were ISO 9001:2015 compliant for years, so it was a badge of honor for us to get the ball rolling and complete the certification process. It’s all about following quality practices to the letter, managing risk, limiting any errors and documenting what we do.”

While the certification was something the MOLTOX team wanted to accomplish for itself, Rundell said it also should reassure customers and potential customers that the company is paying close attention to the quality and consistency of its processes. But that’s nothing new. “We’re fortunate to have a stable customer base and we work every day to keep all of them happy,” she pointed out.

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MOLTOX offerings

Included among the company’s offerings are Petri plates, reagents, and a line of materials to support the Ames assay, a widely used test that deploys bacteria to find out if a chemical can cause mutations in the DNA of test organisms. MOLTOX’s products are used by global pharmacology and research labs to determine if a drug is suitable for clinical trials, for example, or whether a cosmetic ingredient is safe to use.

The company also manufactures a variety of products designed for industrial microbiology research.

MOLTOX is headquartered in Boone Industrial Park and has a team of 15 employees. It got its start in 1986 when molecular toxicologist John Rundell, Ph.D., recognized the need for standardized materials that could be used in genetic toxicology tests. The company initially located in Maryland but moved to the North Carolina mountains a few years later.

Kristen Rundell is John Rundell’s daughter-in-law. She assumed the role of president in 2021 from his daughter, Heather Cameron, who had managed MOLTOX for 25 years. John Rundell remains CEO, but “keeps an eye on things from a distance,” Kristen said.

What will MOLTOX do for an encore? “This year we’re going to automate more of our manufacturing processes,” she added. “And we want to support the Boone community in a bigger way. We feel blessed to be here, and we’ll soon roll out a company-wide program to match our employees’ contributions to charitable organizations in the High Country.”

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© North Carolina Biotechnology Center

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