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Adonat® premium SAMe: Quality for health and environment
Sustainability has been a focus of Gnosis by Lesaffre’s efforts, utilizing natural fermentation for its quality active ingredients, including S-Adenosyl-Methionine (Adonat® Premium SAMe).
April 11, 2024
4 Min Read
© Gnosis by Lesaffre
Sponsored by Gnosis by Lesaffre
Written by Lorena Carboni, Product Manager SAMe with Gnosis by Lesaffre.
Fermentation is a sustainable alternative to traditional production processes because the live organisms used produce organic waste substances that are biodegradable and renewable as biomass.
Gnosis by Lesaffre has been operating for decades in developing and commercializing active ingredients obtained from the fermentation of yeasts and bacteria for the nutritional/nutraceutical and pharmaceutical markets, defining a footprint of sustainable processes and respect for natural resources.
Consider a case study: Gnosis's continual striving for a minimal global impact while measuring and monitoring the quality and sustainable production of one of its most established ingredients: Adonat® Premium SAMe (S-Adenosyl-Methionine).
Third-party evaluation
EcoVadis® has become the world's largest and most trusted provider of corporate sustainability assessments, developing a global network of 90,000+ companies assessed since 2007, evaluating supplier performance in the following areas:
Environment
Labor and Human Rights
Ethics and Sustainable Sourcing
As a Lesaffre group-wide initiative, Gnosis underwent an EcoVadis® assessment in 2023, with its pilot plant being Gnosis Bioresearch in Sant’Antonio, which produces Adonat® Premium SAMe. Gnosis was among the 29% of companies assessed by EcoVadis® in the Production of Basic Pharmaceuticals and Industrial Pharmaceutical Preparations.
The EcoVadis® assessment is dynamic because it is an ongoing, intentional process that evaluates corporate sustainability performance: the feedback obtained can be used to create targeted improvement programs to foster corporate sustainability, thereby creating long-term benefits for the company and society. This is what Gnosis will put in place for 2024.
Adonat® as a ‘green asset’
Although there is a distinction between ethical responsibility and sustainability, Gnosis offers Adonat® Premium SAMe brand as a virtuous green product. First, industrial production is done by fermentation of Saccharomyces cerevisiae yeast. Fermentation is cost-effective and environmentally sustainable, requiring less water and fossil sources, and producing less waste during the production cycle.
More generally, Gnosis SAMe is a green choice for customers because it meets specific needs:
A ‘controlled origin’ in a European factory that operates under cGMP applying the most stringent quality and control procedures, which includes the internal HACCP ‘Self-Control Plan’ of the materials used for production.
A focus on controlling contaminants that may enter the production cycle, a measure prioritized by quality-conscious suppliers.
Most recently, Gnosis conducted a comparative quality analysis on three main SAMe ingredients in the market that confirmed the superior quality of Adonat® Premium SAMe. This ‘Quality-Based Assessment’ was an in-depth evaluation of representative batches of several competing commercial products subjected to physicochemical characterization to assess product quality. Some of these tests have relevance considering the results obtained, including:
The percentage of active isomer (S,S) responsible for the ingredient's efficacy and biological activity must be as high as possible at batch release because it tends to convert to the biologically inactive isomer (R,S). Adonat® Premium SAMe has the highest isomer (S,S) content, 9-15% higher than other commercially available SAMe ingredients tested at release time. For the product's entire shelf life, Gnosis guarantees an isomer (S,S) percentage of ≥75%, 25% more than the USP Monograph requirement of ≥60%.
The molar ratio between the SAMe ion and p-Toluenesulfonic acid dictates ingredient stability. While an improper ratio is not immediately visible, brief stress studies can show discoloration indicative of degradation processes. Considering the overall results, only one SAMe tested has a molar ratio that approaches the quality of Adonat®.
An in-depth analysis of total elemental impurities is mandatory for active pharmaceutical ingredients (APIs) to characterize the quality profile broadly, but is not required for nutritional ingredients. Adonat® Premium SAMe has more than five times less total elemental impurities than the lowest tested ingredient.
A nonspecific test, more generally called ‘Heavy Metals’, is intended as a limit test based on a complexation reaction that detects heavy metals down to 10 ppm (expressed by weight, as lead). It offers the advantage of going beyond the four toxic metals routinely checked in nutritional ingredients (As, Cd, Hg, and Pb). Adonat® was well below the threshold level, while two products tested were non-compliant.
This project is part of Gnosis's commitment to perpetuating Adonat® Premium SAMe's position in the market, considering that SAMe is a naturally sensitive and unstable polyvalent active ingredient, especially to moisture and heat. Mastery of manufacturing and downstream processes is critical to ensure the quality of this multi-beneficial ingredient and sustain the finished products' success.
Conclusion
Gnosis has long focused on sustainable production of its active ingredients. The company and its Adonat® Premium SAMe are emblematic of an unwavering commitment to delivering the highest quality products with minimal global impact.
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