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ChromaDex's CDMO: Grace's FCMS

Looking to take its flagship nutraceutical from lab to production, ChromaDex called Grace's FCMS

Over the past 20 years, ChromaDex has evolved from being an expert in natural products chemistry to one that develops dietary supplements, says founder Frank Jaksch. Those roots in fundamental chemistry led ChromaDex to adopt a science-based approach to its flagship dietary supplement, Tru Niagen®. This is the brand name for the compound nicotinamide riboside, a key regulator of cellular energy metabolism.

“In developing Tru Niagen®, we followed more of a drug development path than a standard dietary supplement approach,” Jaksch says. This meant more rigorous attention to a number of considerations, including finding a contract manufacturing and development organization (CDMO) that could scale production to volumes required to meet commercial demand.

ChromaDex had worked with W. R. Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS) on other development projects and understood the firm’s strength in synthetic chemistry. “We knew Grace could handle manufacturing a complex molecule such as a nucleoside,” Jaksch says. “We also knew that Grace could accommodate the good manufacturing practices needed to meet regulatory requirements.” Dietary supplements like Tru Niagen® are regulated by the US Food and Drug Administration as a category under food.

A successful CDMO partnership

“Grace very quickly went from a bench-scale process to fully scaled production delivering metric tons on a pretty impressive short time schedule,” Jaksch says.

“Grace has been able to keep up with manufacturing demands and handle our growth as we needed more material and sold more of it,” Jaksch says. Tru Niagen® is now available online through retailers including Amazon and Walmart, as well as Watsons in Asia.

Jaksch also appreciates Grace’s commitment to continuous process improvement, such as identifying ways to process material that have improved the stability and shelf life of Tru Niagen®.

“Nicotinamide riboside is not the easiest product to make,” Jaksch points out. “From the beginning, we knew it was challenging. It takes a certain degree of skill to make large quantities of nicotinamide riboside with the necessary quality.”

“We needed to find the right partner to translate ChromaDex’s vision to the dietary supplement market,” Jaksch says. In Grace’s FCMS, ChromaDex has found just such a CDMO partner.