04/05/12: The Pure Probiotic Initiative: Ensuring Probiotic Identity and Potency

The Pure Probiotic Initiative: Ensuring Probiotic Identity and Potency

Over the past 5 years, more than 500 human clinical trials have examined the benefits of probiotics in maintaining health and wellness. Much of this research has examined condition-specific efficacy of well-defined strains at particular potencies. In practice, a clinician’s translation of the latest findings into effective protocols demands unconditional confidence in the identity, potency and consistent quality control of probiotic products.

Ensuring identity: Comprehensive identity validation

As living organisms, probiotics continually modify their own metabolism and composition in response to genetic and environmental factors. Consequently, conventional testing methods predicated on metabolism and composition produce variable and unreliable results. Genotyping, the exemplary method of modern microbial taxonomy, excludes these factors to precisely authenticate genus and species according to DNA sequence. Since this genetic method can only validate genus and species, a second method is required for strain verification. Fatty acid methyl ester (FAME) analysis examines the profile of fatty acids in a probiotic and searches for a match among 2,000 strain-specific reference profiles. This comprehensive identity validation of all Pure Encapsulations Probiotics, as part of our patent-pending product process, is conducted through independent laboratories equipped with the most advanced microbial identification technology and expertise.

Ensuring viability: The Pure Probiotic Initiative

Bacteria are delicate organisms that are particularly sensitive to temperature and moisture. To properly optimize these parameters, handling and manufacturing procedures must include strict specifications that extend beyond the scope of standard GMP compliance. Pure Encapsulations’ patent-pending manufacturing process focuses on the vulnerability of probiotics at the most critical steps. Based on a model that minimizes the cooperative impact of the three most important factors—temperature, humidity and timing—the process maximizes viability from the moment of raw material receipt through the date of finished product expiration. It is widely recognized that control of ambient temperature supports probiotic survival. Of equal importance is avoidance of sudden and severe temperature shifts, such as those resulting from freezing and thawing. Circumventing these fluctuations during production is a focal point of the Pure Encapsulations process (Figure 1). Operating within a defined temperature range, together with rigorous observance of time limits for sensitive operations such as blending, enhances probiotic resistance to another threat—moisture.

Figure 1. Overview of the patent-pending probiotic manufacturing process. Exposure to moisture and temperature fluctuations is controlled at every step to maximize finished product viability.

To survive inside of a capsule, probiotic bacteria must remain in a dormant state during which nutrient demands are minimal. Exposure to moisture stimulates metabolic activity and nutrient requirements, which are unrequited until they enter the body. At the formulation stage, quiescence and stability can be maximized by controlling water activity (Aw), a specific thermodynamic measure of water availability. Probiotic products with a low Aw maintain greater potency from the time of manufacture through the date of expiration. Preliminary research shows that the low-Aw rice starch used in all Pure Encapsulations probiotics increases survival by up to 300% compared to cellulose. Importantly, common co-ingredients, such as prebiotics, are excluded from all formulations due to high Aw values and other concerns.

As part of a long-standing commitment to manufacturing excellence, Pure Encapsulations continues to raise the standards of probiotic quality. As new technologies and scientific discoveries emerge, strategic innovations will continue as part of a dedication to the most scientifically advanced definitions of purity and potency. Excellence in manufacturing, together with proof of identity and potency, comprise an unconditional promise to ensure confidence in every probiotic product.

Click here for a full listing of our probiotic products.

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