THE SCIENCE BEHIND
We are proud to say that all of our products are manufactured in facilities located in the US and are compliant with the cGMP regulations as stipulated by the FDA.
All of our products go through several quality and purity audits before the products are shipped.
We are a research-based company actively working on developing synergistic compounds and are proud to create innovative products with proprietary rights.
We have several licensed products as well as in house IP on several products related to our products.
OUR RESEARCH AND DEVELOPMENT PROCESS
Our Research and Development process is what makes us unique and we take it seriously. Our company was founded on the idea of comprehensively validating every product we sell. Our products pass through a rigorous process of research and testing before they are available for purchase.
Our research process begins with a comprehensive evaluation of the scientific literature to understand the research problem thoroughly.
Once we identify a synergy element or a promising compound, we do extensive background research on the product and do an initial in-vitro analysis to ensure the claim of efficacy is valid.
Preclinical Model Development
Through various preclinical models and with results of initial investigations, we explore the possibilities of development of several formulations for the final product.
We utilize industry-renowned and GLP compliant(exceeding) Contract Research Organization to validate our formulations to help us achieve a neutral third-party validation.
Note: If a product fails the third-party validation, we cycle it back to Research and Development and further exploration. Products that fail the CRO do NOT go on to be validated.
Product Evaluation and Safety Investigation
We use a third-party compliance group to evaluate our manufacturing methods and product safety to ensure we meet and exceed the FDA standards.
Our final product goes through several rounds of beta testing/efficacy testing before its released to wider audience.
WHY OUR PRODUCTS WORK
The use of in vitro cell-based models in research has ethical and cost advantages over in vivo models. Development an in vitro three-dimensional (3D) perfused culture model of islets for maintaining viability and functionality longer is the gold standard for drug screening and efficacy.This process essentially helps in creating miniature pancreas similar to what’s present in the body.This testing method is utilized by major pharmaceutical as well as nutraceutical companies across the world. Islet cell cultures are very difficult to maintain and they do not proliferate and are not self-renewing. Islet cells are one of the most sensitive cell groups to inflammation in the body, for this research study, the islet cells were cultured in a high glucose environment to further stress the cells and to simulate a diabetic condition.
Scientific Design Process:
A scientifically validated design process was used to create an optimal synergistically active amino acid blend for islet health. Initial testing began with the testing of individual amino-acid component of the blend. These tests were completed on cultured pancreatic Human beta-cells, which are the insulin-producing cells of the body. In the graph, each colored line represents an amino acid. The 100% indicates the percentage of beta-cells that were alive when tested against a extremely high concentration of each ingredients to understand the toxicity and efficiency of each ingredient. Very few amino acids had a positive effect on beta-cell health when applied by themselves. Several of the amino acids had negative effects on beta-cell viability at higher concentrations.
A group of islet cells without the patented formulation was used as a control group. The comparison was based on three factors; the number of dead cells within islets over time, a count of the number of islets surviving over time, and the functional test of cellular metabolism after long-term exposure.
Freshly-dispersed islets were exposed to high-glucose conditions to mimic a diabetic state. (11.6 mM glucose which is equivalent to approximately 210 mg/dl blood glucose for humans) During the long-term (11-day) exposure, the islets were subjected to the patented amino acid formulation (all at the same concentration) with culture media that had no added amino acids.
The objective of the experiment was to test the effects of long-term exposure of islets to Almeda Labs patented amino acid formulations. This helped us understand whether our formulations maintained their high viability rate and enhance vitality.
Islets exposed to Isle™ had higher viability, improved survival and higher metabolism compared to controls.
As a research focused company we have a series of products in different stages of product development and we want to give you a quick preview of the amazing things which are going to be released in the near future as soon as we are done with the testing.