Advanced Breath Diagnostics, LLC

Keith Darrel Evans

Stanley John Konopka

Kerry Clepper Bush

Eric Charles Henry

William Michael Houston

A standardized, lyophilized edible food containing a biologically safe stable marker for use in the measurement of gastric emptying by the quantification of marker excreted in the breath of the patient.

Lyophilized edible food incorporating a marker and methods of making

Lyophilized edible food incorporating a marker

A method and apparatus for preparing uniform carbon-13 labeled biomass using a water soluble carbon-13 labeled carbon source, such as a [C]-bicarbonate or [C]-carbonate salt, is disclosed. The biomass is prepared in one or more sterile carboys filled with growth medium, in which acidity, oxygen, and biomass density are carefully monitored and maintained. By using a solid, water-soluble [C]-bicarbonate or [C]-carbonate salt as the sole carbon source, a biomass is provided which is uniformly and efficiently labeled with carbon-13. This method and apparatus is particularly useful for the growth of an edible carbon-13 labeled algal mass, withbeing a specific alga species. The biomass may be prepared in conformance with FDA current good manufacturing practice regulations, and may be harvested and formed into lyophilized bulk drug powder which may be further processed into various drug product forms which are useful for diagnostic tests or in pharmaceutical compositions.

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Brentwood, TN, United States of America

Keith Darrel Evans