Immuron leverages advanced dairy industry technology and a significant body of human clinical studies to produce safe, oral formulations of antibodies and other bioactive proteins of value. Immuron's antibodies and proteins are harvested from the first postpartum milking of dairy cattle (colostrum or “immune milk”). These cattle have previously been immunized with Immuron's proprietary vaccines before calving, and have been monitored to assure vaccine immunogenicity. Primary bovine colostrum (BCP) from these cattle have a naturally high concentration of immunoglobulins  as well as a high natural concentration of other proteins, and include antigen target immunoglobulins specific to the vaccine antigen we have used.

Immuron works with world class academic and governmental health institutions to improve our vaccines, characterize our bioactives, and demonstrate clinical efficacy and safety for our products. As a result, we hold an ever-expanding intellectual property portfolio to maximize potency and clinical use of Immuron's novel formulations targeting  specific diseases. This includes issued patents and patent filings concerned with preparation of our vaccines, collection of colostrum, economic processing of our bioactives, oral delivery of our products, specific mechanisms of disease prevention and treatment unique to our approaches.

Manufacturing technology
Our manufacturing technology is highly scalable and allows for rapid and low cost development and commercialization for a broad range of immunotherapeutics. Produced under rigorous dairy industry standards, our active ingredients are freeze dried into powder and can be packed as tablets, capsules, bulk dry powders or individual sachets for point of care reconstitution, or in combination with other active ingredients.Current Immuron commercial process yields an export-grade certified dairy ingredient product that includes casein and other colostral bioactive proteins obtained exclusively from first milking colostrum of vaccinated dairy cows within commercial milk-producing herds. The product is registered by DairySafe Victoria for domestic and export use, and meets GMP including microbiological safety standards for export as a dairy food and for use as a pharmaceutical product ingredient.

Both the manufacturing process and the starting material for Immuron's Hyper-Immunized products are unique to  Immuron formulations. The system used by Immuron yields a high immunoglobulin concentration (>40%), while retaining high levels of other proteins. Additional formulation methods allow us to use natural proteins to enhance the bioavailability of the active immunoglobulins at the gastrointestinal mucosal surface where they can benefit the patient.

Regulatory
All of Immuron's dairy-derived product is 100% BSE free, Kosher and non-GMO. This allows the company to export into all other countries under dairy food ingredient import regulations. Immuron's bioactives are already being commercialized in the marketplace under a variety of regulatory pathways depending on the clinical claims being sought and indications for use. Importantly, as an all-natural dairy food product, there are a number of rapid pathways to market based on our products’ high safety profile. Our product platform has received GRAS (Generally Regarded as Safe) status based upon expert panel review at the Therapeutic Goods Authority (TGA), the Australian national equivalent to the US FDA, and has received self-affirmed GRAS status, as defined by the US FDA, by an international panel of physician experts.

Oral Immune Modulation- PIPELINE PRODUCTS PENDING APPROVAL OF HADASIT TRANSACTION
Immuron has signed a deal to acquire important and novel immune oral modulationa from Hadassah Medical Center.  The pending transaction covers a technology, that when used in combination with Immuron’s own ”immune milk” antibodies and  proteins, can directly correct deficiencient regulatory T  cells (Tregs), a type of immune cell known to have profound  effects in controlling  inflammatory responses, immune activation and suppression in many diseases. This novel approach has shown positive effects in several validated animal models of human disease, including type II diabetes and metabolic syndrome.

Anti-LPS Antibody
Lipopolysaccarides found in gram negative bacterial cell walls are implicated as key drivers of GI inflammation as well as in HIV/AIDS pathogenesis. Immuron has a proprietary vaccine that can generate high affinity, orally delivered polyclonal antibodies that bind LPS.
Data supporting this work was first presented  by scientists from Murdoch Children’s Research Institute, Royal Children’s Hospital, Parkville, Victoria and the Department of Microbiology & Immunology, University of Melbourne at the Australian Society for Microbiology annual meeting held in Melbourne.


 
Broad, cross-reactive anti-LPS antibody activity can have direct as well as immune-mediated impact that is highly relevant in a number of gastrointestinal diseases.

Commercial Advantages for Immuron's Technology
Rapid Scale Up: May require as little as 3 months to obtain new antibody formulations in a form for clinical trial.
Economies of Scale: With access to enormous numbers of dairy animals, large-scale rapid production is feasible and cost-effective.



Cost Advantage: BCP-derived polyclonal immunoglobulins are a fraction of the cost of monoclonal antibodies.
More rapid and less costly regulatory pathway: While specific designations for food-based, natural GRAS-affirmed products vary from country to country, Immuron's pipeline products have in general a much shorter and less costly expected path to commercialization than   comparable synthetic pharmaceutical  or biological products.



Platform Based: Ability to raise a variety of antibodies against bacteria, virus, and other molecules for delivery to the GI tract, the upper respiratory tract and topically, as required.