For Immediate Release
Nu Science Trading, LLC
January 21, 2015 Phoenix, Arizona
Nu Science Trading (NST) and Viridis BioPharma announce an unprecedented Quality Assurance achievement for natural Vitamin K2-7 (MenaquinGold®) with receipt of NSF International Good Manufacturing (GMP) Registration.
The achievement is unprecedented because the NSF certification was awarded to their production facility, Synergia Life Sciences, which is already UL cGMP (21CFR Part 110/111), ISO 22000 and HACCP certified. The Vitamin K2-7 production plant, where MenaquinGold® is produced, meets pharmaceutical manufacturing standards with an equivalent Drug Master File (DMF) in place.
Vitamin K2-7 has gained significant interest and awareness over the past three years due to important publications from a variety of research institutes. Most recently, researchers Verstreken, et. al. were successful in correcting the effects of one of the genetic defects that leads to Parkinson’s disease with Vitamin K2 in an animal model of the disease. Other publications from European research institutes and highly accredited US institutes such as Tufts University have shed light on the need for Vitamin K in the diet as it has effects on the risks of chronic diseases such as cancer, diabetes, osteoporosis and heart disease.
Vitamin K2 is involved in the carboxylation of certain glutamate residues in proteins to form gamma-carboxyglutamate residues (abbreviated Gla-residues), which then “turn on” these proteins. These proteins are called Vitamin K-dependent proteins and over a dozen of them have been identified in various tissues in the human body. The most well-known are osteocalcin (for bone building) and Matrix-GLA (for redirecting calcium from arteries). The problem, however, is that Vitamin K2 has all but been stripped from the Western diet and studies estimate that Western populations are sub-clinically deficient in this crucial nutrient. This opens a significant opportunity for dietary supplement and functional food manufacturers to fortify products with and build products around this important ingredient.
However, since Vitamin K2-7 is produced from fermentation and the compound itself is sensitive to light, moisture and other factors, quality assurance is arguably the most important factor when seeking out a source for the ingredient. Fermentation products contain a lot of background (material other than the active) and the fermentation process is prone to contamination. Considering those factors, it is imperative that a manufacturer of Vitamin K2-7 invests in the highest levels of quality assurance to guarantee a stable, safe and consistent product.
“Consumer Labs has demonstrated the issue of unstable Vitamin K2-7 by testing several commercial brands that were formulated with the vitamin. They found that a number of the products had significantly less Vitamin K2-7 activity than what was claimed on the label.” said Mr. Dale Kriz, Managing Director for Nu Science Trading, LLC. “This is not an uncommon issue as Vitamin K2 is a reactive and sensitive compound”, said Kriz.
“As a supplier of prescription grade, natural Vitamin K2-7 to the pharmaceutical market in several countries, we have had to complete dozens of stability profile studies on MenaquinGold® both as a stand-alone and in formulation” said Mr. Ashit Vora, Jr. Managing Director of Viridis BioPharma. Mr. Vora went on to say “it is exceedingly important to verify the stability of your K2 supply both as a stand-alone material and in formulation as well. Most companies forget that in formulation, the story changes and the stability of the Vitamin K2 compound can become compromised.”
Dr. Dilip Metha, CEO of Viridis BioPharma, explained that “the stability of Vitamin K2 is highly dependent on the process by which it is extracted and the consistency of that process. Its stability is influenced by the important supportive profile found in the natural ferment. Characterizing and standardizing that supportive profile is part of our cGMP process which has taken a number of years to develop and perfect. Viridis has completed using advanced analytical techniques–namely, NMR,mass spectroscopy and HPLC-validating the accuracy of the method of analysis and confirming the identity of its Vitamin K2-7. Without stability, Vitamin K2-7 is not efficacious”.
The U.S. dietary supplement makers are becoming increasingly quality conscious as recent GMP requirements are enforced by the FDA. “We feel that NSF provides a great framework for dietary supplement brands to ensure they are purchasing high quality ingredients and we are getting more demand for such certifications. With this in mind, it was an easy choice for Viridis BioPharma to go through the NSF certification process” said Mr. Anirudh Mehta, Jt. Managing Director of Viridis Biopharma.
“MenaquinGold® now has a comprehensive body of certifications with NSF, UL cGMP, ISO 22000, HACCP and an equivalent Drug Master File (DMF); this makes the brand an unprecedented offering in natural Vitamin K2-7 supply. We are very proud to support the growing market with an offering of the highest standard”, Kriz said. MenaquinGold® is also soy free, allergen free, vegan, self-affirmed GRAS, Kosher and Halal. MenaquinGold® is now available in water-soluble form.
Nu Science Trading, through its long-term partnership with Viridis BioPharma, is offering MenaquinGold® in North America. The product is available to dietary supplement and food manufacturers in bulk form.