Nonclinical testing of formulas containing hydrolyzed milk protein

The allergenic potential of cow milk-based infant formula can be reduced by protein hydrolysis. Controlled clinical studies are necessary to demonstrate conclusively the biologic efficacy of these formulations in human beings. Nonclinical testing programs provide manufacturers with the opportunity to characterize various molecular and immunologic properties of these hydrolysates and their corresponding final product forms. Physicochemical analyses provide data relating to the extent of protein hydrolysis and peptide molecular weight distribution. Immunochemical analyses can semiquantitatively estimate hydrolysate reactivity with preformed antibody. The ability of hydrolysate-based products to induce an immune response can be evaluated by using animal models. It is the responsibility of the manufacturer to choose the appropriate combination of nonclinical tests and use them to document product consistency, thus helping to ensure consistent clinical performance.