Product quality and reliability supported by a number of studies for about 30 years

Our proprietary probiotic strain, the TH10, was discovered from “Tempeh”, a fermented food in Southeast Asia by a noble effort of Iichiroh Ohhira, Ph.D., one of Japan’s leading microbiologists in 1988. Upon examining the proteolytic properties among 180 or more kinds of lactic acid bacteria, we found out that the TH10 strain has 6.25 times greater proteolytic properties than the others.

Twenty years have passed since the discovery, and more than 20 research papers have been published in academic journals and presented at many conferences. Furthermore,　we have actively collaborated with researchers from home and abroad for studies and published a number of clinical test results.

OM-X, a vegetable extract fermented with the TH10 and other probiotic strains, keeps receiving scholarly attention and further benefits are discovered, including an antioxidant property, relief of constipation and improvement in immunity and allergic symptoms. Our stance of placing importance on research activities is valued internationally. Doctors and hospital facilities outside Japan accept and use OM-X.

Production with a pharmaceutical manufacturing technology at the GMP certified factories (GMP in a dietary supplement category)

We conduct strict quality control on OM-X. At the moment of arrival of raw materials, we thoroughly check for contamination by harmful bacteria. A few hundred fermentation barrels in our factory undergo strict monthly inspections from the start of its fermentation to five years later (longest). The test items are counts of probiotic strains and the presence or absence of harmful bacteria and foreign objects. 

The final product also undergoes an inspection with respect to check items like capsule features, viscosity and water content. We only supply a product that is completely assured in its quality. Among various production processes, we strive to achieve a high-quality encapsulation. Generally, a viscous paste is deemed difficult to fill into a soft capsule. We have tackled this technical challenge after a long time of trial and error, and finally completed the development of its encapsulation method. We produce OM-X with a pharmaceutical manufacturing technology at the GMP certified factories (in a dietary supplement category). We have achieved to encapsulate OM-X without high heat process.

Nutrition analyses, LAB count tests, Residual pesticides tests, Heavy metals/toxicity tests, Radioactivity analysis

Every production lot of the final product is examined by third-party organizations. The product quality is evaluated by LAB count tests and nutrition analyses to inspect the amount of amino acids, vitamins, minerals and organic acids. Product safety is secured by residual pesticides tests and heavy metals/toxicity tests.

We also conduct thorough checks of radioactivity at the moment of arrival of each raw ingredients. The radioactivity analyses are conducted for each production lot at the Japan Food Research Laboratories. After they confirmed that no radioactive substance was detected, they release their certification.

The high level of safety of OM-X was confirmed in a clinical study and published in an academic journal

In recent years, the needs for having a safety trial in humans have increased. Corresponding to such needs, we conducted a collaborative study with Harvard Medical School regarding the product safety in Healthy Volunteers. The high level of safety of OM-X was confirmed and the results are published in an academic journal. Our attitude of pursuing further product functionalities and safety receives a favorable reception.

Our research and development laboratory voluntarily carries out various quality control activities in all stages of manufacturing products from the preparation of raw materials – during the blending processes - final products.

We participate in the external precision control examinations every year in order to objectively evaluate the reliability of our voluntary inspection.

Our company participated in the first test to evaluate the skill of bacteriological examination in the 2017 fiscal year which was sponsored by the Japan Food Inspection Corporation, and acclaimed our skills regarding the examination of viable bacteria count, coliform group, E. coli and Staphylococcus aureus as excellent. It was confirmed that there is no problem with our inspection method and the skills of inspectors, and the data is correctly obtained at our laboratory.

We will maintain and improve our inspection technique in order to convey safe and reliable products to our customers.