As Agropur V.P. of Research & Development (Ingredients) Anand Rao stated in the award entry, “the amount of GMP in these whey protein ingredients varies around 15% to 25% of the total protein. To our knowledge, only one other dairy ingredient company manufactures a WPC with 60% GMP. In 2016, Agropur introduced high-purity, fractionated whey protein isolate with over 95% of total protein in the form of GMP.”

Agropur’s GMP ingredient is being used in commercial formulations. It is manufactured in Jerome, Idaho. The R&D team is located in Le Sueur, Minn. Pilot trials started in 2016 and full-scale commercial production started this year. The ingredient is packaged in 20-pound kraft multiwall bags and 20-pound cardboard boxes with internal lining.

The company stated that “the highly purified GMP expands the applications of dairy-derived protein beyond meeting nutritional needs, into potential pharmaceutical applications.”

GMP is an intact dairy protein

According to Agropur, phenylketonuria (PKU) is an inborn genetic error in phenylalanine (Phe) metabolism, and its presence requires lifelong nutrition management with a low-Phe diet. This includes a Phe-free amino acid-based medical formula to provide the majority of an individual’s protein needs. Compliance with this diet is often difficult for older children, adolescents and adults with PKU. The National PKU Alliance reports that the incidence of PKU in newborns is between 1 in 10,000 to 1 in 20,000 live births.

Pure GMP is ideally suited for the PKU diet since it does not have any Phe. Nutritionally complete acceptable medical foods and beverages can be made with high-purity GMP to increase the variety of protein sources for the PKU diet.

As an intact dairy protein, GMP improves protein utilization and increases satiety compared to an amino acid-based diet. High-purity GMP provides a new, more physiologic source of low-Phe dietary protein for those with PKU. Agropur’s high-purity GMP is said to contain 1 to 2 milligrams Phe per gram protein, which makes it highly desirable for PKU-formulations.

GMP in toothpaste

Casein-derived peptides, including GMP, are known to have anti-microbial properties. GMP specifically has been identified as a protein fraction that has protective properties against dental caries and plaque formation. The global dental care company, Colgate-Palmolive has applied for several different patents on use of GMP in a dentifrice for anti-microbial properties (WO1997040811 A1), and for remineralization (US6207138 B1)

Because of its use of ion-exchange technology for isolation and purification of specific dairy ingredients, Agropur is well-placed to fractionate GMP from the whey stream. The processor’s thorough understanding of protein chemistry, process technologies and engineering capabilities to scale up manufacturing were key strengths in its ability to manufacture a high-purity GMP powder.

In addition to the existing capabilities of ion-exchange technology, Agropur had to make minor modifications to the manufacturing facility and equipment. These modifications were essential to eliminate contamination from other whey proteins and keep the Phe content as low as possible.

Since there are no established Standard Methods for purified GMP, Agropur’s R&D team had to develop internal methods to ascertain purity of the ingredient it manufactured. GMP’s nitrogen content is very different from that of the standard proteins, thereby making the use of standard N-conversion factor (6.38) of dairy protein not valid for this highly purified ingredient. The research team had to conduct theoretical and experimental evaluations to establish a new N-conversion factor for GMP.

Agropur stated it is investing resources in evaluating the biological properties of purified GMP. Working with academic researchers in the United States and abroad, Agropur is validating some of the biopharmaceutical properties attributed to the casein-derived peptide.  

— The information in this article was drawn from Agropur’s entry in the Breakthrough Award for Dairy Ingredient Innovation competition. ADPI and Dairy Foods are accepting entries for 2018. Go to dairyfoods.com/ADPI-Breakthrough-Award.