Compositions, processes of production, sterilization, and health-promoting uses of lyophilized milk

An oral dosage form comprising commercially sterile lyophilized whole human milk and optionally a physiologically acceptable excipient or carrier for use in the treatment of a digestive system disease or disorder, the treatment of a skin disorder, and/or for increasing immunity in a human, wherein said commercially sterile lyophilized whole human milk is produced by a process comprising:

• a) initially freezing raw whole milk;
• b) cold thawing the initially frozen milk to obtain a flowable concentrate and freezing the flowable concentrate at a temperature from −4° C. to −80° C., to obtain a layer of predefined thickness, or
• cryoshaving the frozen milk to obtain frozen flakes/chips and forming a layer of a predefined thickness from said flakes/chips and cooling the layer to a temperature from −4°° C. to −80° C.;
• c) drying the formed layer at a temperature from −20° C. to +60° C. at a pressure from 5 micron Hg to atmospheric pressure to provide the lyophilized human milk;
• and
• d) treating the lyophilized whole human milk via flash supercritical CO2 treatment, to form the commercially sterile lyophilized whole human milk,
• wherein the commercially sterile lyophilized whole human milk has 90% or more of its immunoglobulins relative to the amount of immunoglobulins present in whole human milk prior to a sterilization step.