Preserving Probiotic Potency
Probiotics and our Gut
In‐licensing and Acquisition Opportunities
Enterologics is actively seeking to in‐license or acquire probiotic strains that are suitable for development as biologic drugs. Candidates must have the potential for addressing unmet therapeutic needs for gastrointestinal diseases.
We will develop these probiotics as live biotherapeutics (biologic drugs). We will follow a rigorous but
efficient template designed to support FDA approval and to meet the high standards demanded by the medical community. Our strategy is aligned with recent draft guidance from FDA for developing live organisms.
We welcome contacts from individuals, research institutions or other companies with products that meet our desired profile.
Delivering an effective dose of live bacteria
How can you know if probiotic products purchased over‐the‐counter contain live, active bacteria? The answer is, you can't be certain. Some product labels provide no information about the probiotic strain or number of viable cells per serving or capsule. Others report counts of viable cells at the time of manufacture, not at the time of purchase. Some are sold refrigerated, but there is no guarantee of proper handling during shipment to the store.
Why is this important? Potency is a critical piece of information, especially since traditional freeze‐drying approaches may damage probiotics. They may be particularly vulnerable to temperature, which is why some probiotics are only found in refrigerated cases. Lack of effective preservation technology may be the single biggest reason that clinical testing results for probiotics have been so variable.
Enterologics has identified a new, state‐of‐the‐art technology for preserving probiotics so that they can be stored at room temperature without loss of potency. The technology was invented by Universal Stabilization Technologies, Inc. We have an exclusive option to evaluate and license this technology for use in E. coli probiotics. Our goal is to produce products that can meet the rigorous standards of biologic drugs for potency. Because a stable, viable delivery format is a critical element for medical applications, this new preservation technology is a core element of our development program.
Gut flora. About ten times as many bacteria reside in the human gastrointestinal tract as there are cells in the human body itself. These bacteria form a complex ecosystem that is vital to our health, normal immune function and digestion. The ecosystem of thousands of different gut bacteria is called the "gut flora" or "microflora."
Just as each of us has our own unique genetic code, or "genome," each of us also has our own particular blend of bacteria, as shown by new genetic fingerprinting techniques that can demonstrate our unique "microbiome."
The gut flora, with thousands of bacterial strains, including potential pathogens, forms an important part of our digestive process but can lead to serious disease if the gut lining becomes compromised and bacteria enter the bloodstream. Alterations in the various bacterial populations in the gut flora can also cause problems, such as when antibiotics may kill or reduce certain types but not others.
Probiotics. Probiotics are living bacteria or yeast that have a beneficial effect on the health of the individual consuming them. Many probiotics have been indentified among the bacteria and yeasts that are used to ferment and preserve foods and have likely been part of the diets of people throughout the world for thousands of years.
Over a century of study. At the dawn of modern biology early in the 20th century, the Russian scientist and Nobel laureate Eli Metchnikoff first suggested that it would be possible to modify the gut flora and replace harmful microbes with useful ones. Metchnikoff's hypothesis about the utility of health‐promoting bacteria was overshadowed by the development of antibiotics, which allowed modern medicine to make great strides in curing diseases that caused epidemics just a few generations earlier. The study of probiotics was largely forgotten during the mid‐part of the 20th century.