The first step in development is to develop pathogen-specific vaccines to target key virulence factors such as

These target antigens are important factors contributing to infection of the pathogen in the human host by causing

Prior to calving, cows are immunized with pathogen-specific vaccines and after calving, the first milk, called bovine colostrum is harvested and processed to produce a hyper-immune bovine colostrum powder. This proprietary process of immunizing cows with vaccines composed of antigens specific for therapeutic targets ensures that the colostrum contains a high (“hyper”) concentration of polyclonal antibodies (“immune”).

The next stage is to prepare the active pharmaceutical ingredient (API) by collecting  the first milking colostrum of dairy cows followed by manufacture to a colostrum powder using spray or freeze drying technology. The polyclonal antibodies (API) are present in high concentration within the raw material i.e., harvested bovine colostrum which is further processed to produce a tableted form of the final drug product; which contains at least 35% immunoglobulins (Ig), composed mainly of IgG (mostly IgG1).

Risk management covering the source of colostrum must focus on assurance of absence of Bovine Spongiform Encephalopathy (“BSE”), commonly known as Mad Cow Disease attributable to the liquid raw product. Australia and New Zealand are classified as Category 1 countries with negligible BSE risk.

Bovine colostrum contains increased concentrations of immunoglobulins (mainly IgG) compared with normal cow’s milk, presented with other physically protective milk proteins. IgGs are not absorbed into the blood and specifically act in the GI tract targeting bacterial antigens and toxins.

The direct protective mechanism of action of our products includes the following

The indirect protective mechanism of action includes