Systems and methods for generating a sterilized human milk product from raw human milk, and sterilized human milk product compositions obtained thereby, are provided. The method includes sterilizing the milk using a countercurrent heating process. The temperature of the milk is raised to a target temperature for a duration of time that is refined to provide a sterilized human milk product with low overall bioburden while also maintaining nutritional quality. As such, the sterilized milk product is suitable for ingestion by premature infants.

The invention relates to a method for the purification of a therapeutic protein from transgenic milk, comprising a clarification step using a salt of poly(diallyldimethylammonium).

Disclosed is a modified colostrum protein having an amino acid sequence shown in SEQ ID NO.: 1, which is generated by replacing Ile at position 33, Glu at position 101 and Arg at position 175 present in the amino acid sequence of a wild type colostrum protein shown in SEQ ID NO.: 2 respectively with Ala, Cys and Cys.

In one aspect, the disclosure provides cells and transgenic non-human mammals for the production of Fc fragments, as well as compositions and uses thereof.

The present invention relates to a pharmaceutical composition for oral delivery, including an anti tumour necrosis factor alpha (TNF) antibody, preferably a monoclonal antibody produced in the milk of a transgenic non-human animal, and which can be combined advantageously with caprylic acid, and is preferably in a form that is suitable for targeted release of the antibody in the intestine.

This invention provides methods and compositions of antibody therapeutics that are therapeutically effective in the digestive tract or below the mucosal barrier of the digestive tract but do not deliver levels of antibody to the systemic circulation that have been shown to be necessary for clinical benefit following systemic administration of antibody. This invention further describes therapeutic compositions of antibody therapeutics that are therapeutically effective in the digestive tract or below the mucosal barrier of the digestive tract but do not deliver levels of antibody to the systemic circulation that have been associated with adverse events and systemic immunosuppression following systemic administration of antibody.

A composition for treatment of African Swine Fever in swine includes avian-sourced antibodies specific for an African Swine Fever Virus isolate. These antibodies are produced by avian animals immunized against the African Swine Fever Virus isolate and mixed with a protective/reactive matrix obtained from, isolated from, or derived from, non-hyperimmune colostrum.