BACKGROUND:   Bacteriological growth media have traditionally been derived from animal, especially bovine, products that are high in nutritional value. These include tissues such as blood, serum, or chopped meat but can also be derived from broths, infusions or extracts of tissues (meat, brain, heart, liver) as well as enzymatic or acidic hydrolysates of meat, gelatin or milk casein. These nutrients, however, carry the risk of contamination by viruses or other infectious agents pathogenic to man, such as the agent of bovine spongiform encephalopathy (BSE or "mad cow disease"). BSE is a transmissible spongiform encephalopathy, such as variant Creutzfeldt-Jakob disease (vCJD) in humans. It is possible that using bovine-derived materials to culture bacteria used to manufacture products intended for humans may increase the likelihood of transmitting an infectious agent present in cows. The use of materials derived from mammals in pharmaceutical products is the subject of ongoing discussions by the US FDA. Using domestic bovine-derived ingredients in the manufacture of drugs or food supplements is currently not forbidden, but could be banned or severely restricted if BSE were to break out in US herds. There is a need for bacterial growth media free of mammalian-derived components, especially from cows, for use in the culture of microorganisms intended to produce probiotics, vaccines, drugs, dietary supplements or other products for subsequent administration to humans.

INNOVATION:   The invention comprises a bacterial growth medium that uses a mixture of non-mammalian-derived ingredients. The medium is made from readily available products that are inexpensive. A panel of 29 generally fastidious anaerobes was selected for a study in which the new medium was compared to Brucella agar, a standard medium for the general cultivation of anaerobes. The results demonstrated that the new medium generally yielded satisfactory, and often better, growth than the Brucella medium. The new medium was generally better for anaerobic organisms prevalent in the gastrointestinal tract, but Brucella medium was better for certain gram-negative aerobes.

ADVANTAGES

1. The major advantage of the new bacterial growth medium is that it eliminates the potential contamination of products intended for human use by infectious agents, such as that involved in BSE, that could be present when using beef-derived components.
2. The medium is suitable for the growth of a wide range of microorganisms.
3. The major components are readily available and inexpensive.
4. The basic formulations may be readily adapted for particular requirements of specific organisms.
5. There is an immediate need for inexpensive bacteriological media free of mammalian-derived ingredients in the United Kingdom, Europe, Japan and Canada, which have regulated or banned the use of beef-derived products due to outbreaks of BSE. The market in the US may be expected to increase as concern about domestic BSE mounts.

1. The new medium may be used in industrial microbial fermentations for the production of:

Probiotic cells, e.g., to replenish normal gut flora after sustained antibiotic treatment;

Live or attenuated vaccines, e.g., pertussis;.

Native or recombinant proteins for use as enzymes or vaccines;

Metabolites, e.g., antibiotics or solvents;

Dietary supplements.

2. The medium may also be used in veterinary applications where the possible introduction of bovine infectious agents into the food chain is a concern, e.g. in the production of vaccines, antibiotics, or probiotics (to compete with pathogenic gut flora) in the poultry, pork and beef food industries.

Reference: UCLA Case No. 2004-098