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Tablets & Capsules October 2015 31 After attending many of the same industry conferences, the CEOs of Meggle, Wasserburg, Germany, and Davisco Foods, Eden Prairie, MN, rec- ognized they had similar business cul- tures and strategic directions. Eventually a friendship developed, which led to a new business endeavor in 2008: A joint venture in which Davisco would manufacture Meggle's pharmaceutical-grade lactose at its Le Sueur, MN, cheese plant. The arrangement benefited both family-owned companies: Meggle could expand its manufacturing capa- bilities in North America—a key mar- ket for its lactose-based pharmaceuti- cal excipients—and Davisco could add value to its commodity products. The similar corporate cultures of the two companies solidified the arrangement. "There are a lot of similarities in our businesses," said Jon Davis, CEO of Davisco. "We are both third-genera- tion family businesses that share the same goals for success. We also share the same ethics, sustainability efforts, and desire to lead with high-value, high-quality, functional products." Both firms also had an appetite for growth. "We have both continued to grow in our respective markets and geographies, but there is little overlap in our respective disciplines, making it an efficient joint venture." In late 2014, Davisco was acquired by Agropur, a Canadian dairy cooperative, but that didn't change its partnership with Meggle. "Even with Agropur now in the picture, Davisco continues to oper- ate independently as the family com- pany it always has been," Davis said. Making the grade Davisco had been making lactose at the Le Sueur site since 2000, but rais- ing the standards to a USP/NF process brings a new set of challenges due to the strict quality specifications. Mike Klein, director of whey operations at Davisco, led the project, and now serves as the joint venture's project manager. "The concept is relatively easy, but how you implement it in our factory versus how Meggle was doing it is not exactly the same," Klein said. "But we get the same result. We just had to translate from what they were doing there and make it work here." Visits to manufacturing sites in Germany and interaction with Meggle's experts also helped. "With dedication, advanced engineering, and some ingenuity you can solve a lot of problems." The biggest difference between the Wasserburg and Le Sueur processes: The first operates continuously and the other in batches. Actually, "contin- uous batch" is a more apt description, Klein said. "We run 20 hours per day of production and then we [clean-in- place] for 4 hours. And then we do it all over again. We're turning it on and turning it off." The first lactose mono- hydrate made on the Le Sueur line— GranuLac 200—shipped in December 2012. Davisco's production volume is about one-fifth that of Meggle's lac- tose operations in Germany. The addition of anhydrous In the pharmaceutical industry, lac- tose functions as a filler-binder and diluent in oral solid dosage forms and is used to deliver inhaled medicines. It's produced in two forms: monohy- drate and anhydrous. In both cases, the process begins with cheese. Milk is curdled and separated. The solid por- tion, the curd, becomes cheese. The remaining liquid, the whey, is concen- trated to extract the lactose, which is then purified multiple times by crystal- lization. Next, the lactose monohy- drate moves into a static fluid-bed dryer, after which it's milled and trans- ferred to the packaging line. After their success meeting the stan- dards of USP/NF for lactose monohy- drate, Davisco and Meggle focused on anhydrous lactose, which required con- struction of a building to house a drum dryer. The building and dryer include a variety of sensors and systems to ensure US-made lactose extends Meggle's reach Meggle's GranuLac 200 lactose monohydrate staged for loading The success of the first venture leads the companies to invest in a second line to make anhydrous lactose