Biotics Research Corporation®

Was formed in 1975 and incorporated in 1976. From day one, the foundation of Biotics Research Corporation® has been Innovation and Quality. Their goals remain unchanged - innovative ideas, carefully researched concepts, and product development with advanced analytical and manufacturing techniques to develop and produce nutritional products of superior quality and effectiveness. Biotics Research Corporation® is an FDA licenced pharmaceutical manufacturing facility. All supplements are produced using the same standards as those required for drug production, ensuring exceptional safety and reliable quality.

Profile

Biotics have a highly skilled scientific staff, academically trained in nature's principles, with extensive research laboratory facilities at their disposal. This consistent approach over the last 30 years has ensured excellent product research and development, especially in areas involving nutrient delivery and product quality and consistency.

Emulsified Fat-Soluble Nutrients and Botanical Extracts

After extensive literature searches and reviews, Biotics focused its research resources on developing an improved delivery method for fat-soluble nutrients such as vitamins A, D, E.  The result was true oil-in-water emulsion of fat-soluble nutrients.  Other emulsions are available in the market, but they were poorly prepared resulting in little or no advantages in uptake over standard oily preparations.  Biotics emulsions are unqieuly distinguishable by direct microscopic examination showing smaller and more uniform particle size. Particle dispersal is accomplished by non-detergent means, avoiding compromising safety and without increasing gut permeability, often seen with micellised preparations.  Their research on the subject was presented to the American Society for Clinical Nutrition[1] and published in the American Journal of Clinical Nutrition.[2]

These emulsified nutrients represent a more cost-effective means of delivering nutrients than micellised, dry, or oily preparations.  Biotics Research also developed a drying process whereby the liquid emulsion can be added to tablets, capsules and powders in a dry form.  This process increases stability and convenience, while still delivering increased uptake of fat-soluble nutrients. To prove this, a double-blind, placebo-controlled study comparing the blood uptake of coenzyme Q10 from powdered CoQ10 versus the emulsified form (as CoQ-Zyme Forte tablets) at a dose of 30 mg daily was undertaken.  The emulsified CoQ10 tablets were shown to double blood levels, a feat not even achieved when 90 mg of powdered CoQ10 was ingested. [3],[4]

Biotics Research Corporation was the first company to introduce Coenzyme Q10 to the North American healthcare market, and uniquely produces its own raw material.

Biotics emulsified nutrients are safely and more completely absorbed by people with gastrointestinal disorders and those with compromised digestion and absorption.  Lower doses of emulsified nutrients are able to be used, resulting in greater compliance and cost-effectiveness, because emulsified vitamins are absorbed into the lymphatic system, rather than the portal system (as when fat-soluble nutrients are micellised).  The lymphatic system normally handles fat absorption, and feeds the immune system directly.  Also, emulsions are found in mother's milk, nuts and seeds.  It is Nature's way of storing fat and fat-soluble nutrients in our unrefined foodstuffs.  Emulsions from Biotics Research, are a perfect example of A The Best of Science and Nature.

Vegetable Culture Product Base

One of the very first steps taken by Biotics Research Corporation was the development of our vegetable culture base to replace the usual and customary levels of inert fillers such as sugar, lactose and starch that were commonly used in the manufacture of nutritional supplements. Various plant culturing techniques were developed, tested, and refined in order to improve the biological activity of potential product bases. After much effort, the vegetable culture base, produced from non-soy legumes, was developed. Harvested at specific stages, our vegetable culture base was found to exhibit ideal characteristics for use as in nutritional supplements. The advantages offered by our "Vegetable Culture" base are numerous, and include the following:

• Biologically-active whole food in place of inert ingredients
• Improved and consistent disintegration, for improved and consistent assimilation
• Improved product stability by virtue of the antioxidant activity inherent in the Vegetable Culture
• Acceptable by strict vegetarians and vegans
• None of the adverse interactions commonly seen with other "fillers" such as lactose
• Allows for tablet and capsule production without or with only minimal use of lubricants such as silicon dioxide

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Proteolytic and Antioxidant Enzymes: Ensuring Stability and Potency

Stability can be a major problem with enzyme products.  Upon actual assay, many products labeled to contain proteolytic or antioxidant enzyme activity were found to be subpotent or completely devoid of activity.  From these lessons, Biotics learned to procure enzymes from only the most reputable of sources, and use state of the art in-house quality control to ensure enzyme activity in finished products.  Smaller batches are produced on a frequent basis in order to consistently provide fresh products.  Although this approach is more complex, it results in products that are consistently of reliable high quality.

Vegetable Culture Minerals (Phytochemically Bound)

The next innovation to spring from the Vegetable Culture was Vegetable Culture Trace Minerals.  Known amounts of trace minerals molybdenum, vanadium, lithium and rubidium were first introduced to health care professionals as Biotics Research Corporation's Vegetable Culture Minerals.  In addition, chromium and selenium were also completely incorporated into the vegetable culture matrix, resulting in the first yeast-free organic forms of these important trace minerals.  Vegetable Culture Minerals combine soluble forms of a particular mineral, with the vegetable culture cells.  Again, conditions of environment and growth are carefully regulated, resulting in the uptake and incorporation by the plant cells.

The Biotics Research Vegetable Culture Minerals are not to be confused with simply mixing inorganic forms of minerals with a foodstuff and then calling the mix an organic mineral chelate. Our Vegetable Culture Minerals are actually organically chelated or Phytochemically Bound.

The advantages of trace minerals as Vegetable Culture Minerals are:

• trace minerals are present in forms our bodies are designed to recognise and assimilate
• organic mineral forms are tolerated better than inorganic form
• organic mineral forms are subject to less interaction with other minerals
• lower doses may me necessary due to better assimilation
• not a yeast source, avoiding potential problems associated with yeast

Clinical Laboratory, Genetic Testing & Love Canal

In the early days, Biotics Research operated a clinical laboratory that analysed blood and urine samples.  In fact, Biotics was one of the first laboratories to provide mineral analysis via hair.  Most healthcare professionals today recognise the benefit of mineral analysis from hair as a non-invasive test for signs of heavy metal toxicity. 

In the late 1970s Biotics Research operated a licensed clinical testing laboratory for genetic toxicology assessment. From a blood sample, white blood cells were cultured and their chromosomes examined under a high-powered photo-microscope. From the examination of the chromosomes, DNA damage could be measured. While this is a very common procedure in clinical and research labs today, in 1979 very few laboratoriesin the world were engaged in such tests.  Biotics Research Corporation® was clearly ahead of its time.

Biotics was contracted by the US Environmental Protection Agency (EPA) to perform a preliminary study on the residents of Love Canal in upstate New York . The neighbourhood was built on a toxic waste site and the residents were having unusually high rates of stillbirths, congenital abnormalities in newborns, as well as other health problems. The residents associated their problems with a toxic waste dump below the community, and they were requested to provide an estimate of genetic damage to the residents in order to determine if extensive studies were necessary.

Serious evidence of genetic damage was identified in a large percentage or residents tested (11 of 36). Unfortunately, this was not the news authorities wanted to hear. Although they tried to refute their findings, ultimately they had to accept the evidence and relocate the residents of Love Canal. Love Canal became a symbol of citizens taking action against toxic chemical pollution, and ultimately lead to the establishment of the EPA Superfund to clean up toxic waste sites.

From Genetic Testing to Interferon

An outgrowth of their genetic testing resulted in the development, production and sale by Biotics Research Corporation®, of the first nutritional supplement to supply known, potent levels of interferon.

The ability to culture cells was derived from the genetic toxicology project, and was utilised to raise human fibroblasts (derived from established cell lines and not derived from foetuses). The scientists at Biotics Research believed the use of human cells was essential. In the early 1980s, interferon production was normally accomplished by adding viruses or viral extracts to cell cultures to induce interferon production. Not wanting to handle potentially pathogenic viruses, Biotics scientists devised a method to induce beta-interferon (now renamed interleukin-6) by adding nutrients that were unheard of at the time. Independent assays established the high level of beta-interferon produced by our cell culture methods.

The concept of oral administration of interferon, which was validated in animal experiments by leading veterinarian researchers, was diametrically opposed to the then-recent attempts by cancer researchers to treat human cancer patients with high doses of purified interferon. They were using doses that were over a million fold of what the body normally produces. It is important to note, interferons are produced in minute quantities by the body, yet still exert powerful effects. Excessive doses of interferon may not actually stimulate the immune system, but may actually cause severe side effects.

Oral administration of Biotics interferon has been documented to deliver physiological doses to the most common target tissues: epithelial (mucous) membranes. However, a leading interferon researcher of the time petitioned the FDA to make interferon an Investigational New Drug. Though the FDA acknowledged that interferon was a normal bodily component (like proteolytic enzymes), they were forbidden by an injunction from continuing to produce or sell oral interferon.

Neonatal Glandulars

Biotics Research realised the importance of neonatal calf serum went beyond the culturing of lymphocytes. From our genetic toxicology work, we knew that neonatal tissues contained foetal growth factors that could keep normal adult cells alive in culture form. We also knew that European Doctors, in efforts to restore health in humans, used “live cell therapy”, utilising injections of foetal (almost neonatal) tissues from animals. They knew that glandular products were becoming increasingly popular with some health care professionals in the United States.

Histological analysis of neonatal and adult glandular tissues documented the cleanliness and vibrant growth state of neonatal glandular tissues compared to normal, healthy adult gland tissue. Clearly, glandular products from neonatal bovine tissues represented a distinct improvement in quality, as compared with other products available.

The process of Cryosolvation was developed at Biotics Research Corporation® to preserve that attributes of neonatal glands and organs, resulting an materials suitable for solid dose production.

Because neonatal glands were relatively fat free, harsh defatting procedures used by others in our industry were not necessary. Instead, modest amounts of a mild organic solvent found in our bodies is used to remove fats that could later oxidise and result in short shelf life. Important compounds, like phospholipids, are not removed by this process. Additionally, low temperature drying preserves enzyme activities and conformation of the numerous metabolic intermediate compounds found in neonatal glands. The results are stable materials suitable for delivery in solid dose form, which preserves the essential qualities of neonatal glands.

Chondro-Protection

Another first from Biotics Research was the concept of Chondro-Protection via supplementation.  In the early 1980's, at the request of a cutting-edge chiropractic physician, Biotics research began researching glyucosaminoglycans (GAGs). They soon focused on Chondroitin sulphates (CS), large, heterogenous biological polymers used by the body to maintain proper elastic integrity within tissues. The chief GAG of cartilage is CS, a repeating disaccharide, specifically glucuronic acid and sulfated N-acetylglucosamine.

Biotics learned that the benefits of CS were enormous. During the repair of injured connective tissue, CS synthesis precedes collagen synthesis and is essential for proper healing. Additionally, CS are structural components of vascular intima, giving strength and elasticity to blood vessels.   They also learned that the aging process causes many changes in CS patterns in cartilage. CS are gradually replace by other GAGs, affecting vascular permeability as well. In addition, the normal synthesis of CS can be inhibited by nutritional deficiencies, and by the use of anti-inflammatory drugs such as cortcosteroids, salicylates, gold salts, ibuprofen, phenylbutazone and other NSAIDs.  The benefits of chondroitin sulfate for patients with osteoarthritis has been well documented[5],[6],[7],[8]  as have the cardioprotective benefits.[9],[10],[11],[12]

Upon determining that high quality chondroitin sulphates could be readily absorbed, Biotics Research was determined to make Purified Chondroitin Sulphates available to its professional clientele as a dietary supplement. But again, the raw material was not commercially available at that time. As was the case with CoQ10, they would have to produce it themselves.

And the rest is history. Today, chondro-protective products containing chondroitin sulfates and glucosamine are among the most commonly prescribed products in the industry. But beware! All chondro-protective products are not created equal.  Recent research suggests that a large percentage of glucosamine and chondroitin products are not as potent as they claim to be.  Biotics Research is the only professional company that has purified chondroitin sulphate as a raw material and has done clinical studies with chondroitin sulphate. Biotics Research uses only purified chondroitin sulphate from commercial sources that meet or exceed NIH standards of purity. With in house laboratory capabilities, chondroprotective agents can be tested and released for manufacturing at Biotics. Many suppliers of chondroitin sulphate provide materials that assay at 30% purity compared to 100% purity. The result is that many products on the market do not meet label claim. Using standardised chondroprotective agents provides for repeatable clinical outcomes.  At Biotics Research Corporation, their testing and manufacturing processes ensure safe and effective products of the highest quality.

Phytochemistry and Quality Assurance Laboratory: An On-Site Advantage at Biotics

Biotics is unique in the health product industry in that they have an on-site laboratory facilities for phytochemistry research as well as a quality assurance program already in place to meet the upcoming changes in FDA regulations.  In the phytochemistry lab, they analyse incoming botanicals for quality, purity, contamination, and potency; products which do not meet our standards are rejected and returned to the supplier, where they are often resent to other product manufacturers.  Having laboratory facilities on-site allows us to constantly analyse and ensure the quality of the products that they make, thus ensuring our doctors and their patients of safety and potency.

Quality control and quality assurance programs are part of the corporate culture at Biotics Research Corporation.  While many companies invested heavily into slick marketing, they often ignore the product.  In the near future, many of these companies will face regulatory extinction because of their failure to invest in in-house quality control, research, development, and faculty development.

Another example of The Best of Science and Nature.

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[1]) Joint Meeting of the American Institute of Nutrition, American Society for Clinical Nutrition, Canadian Society of Nutritional Sciences. University of California Davis .  July 20-24, 1986

[2]) Bucci LR, Sparks WS. Comparison of vitamin A absorption from commercial oil emulsified and micellized products.  Am J Clin Nutr 1986; 116(6): 27

[3]) Bucci LR, Pillors M, Medlin R, Klenda B, Robol H,  Stiles JC, Sparks WS.  Enhanced blood levels of coenzyme Q-10 from an emulsified oral form.  In Faruqui SR and Ansari MS (editors). Second Symposium on Nutrition and Chiropractic Proceedings.  April 15-16, 1989 in Davenport , Iowa

[4]) Bucci LR, Pillors M, Medlin R, Henderson R, Stiles JC, Robol HJ, Sparks WS. Enhanced uptake in humans of coenzyme Q10 from an emulsified form. Third International Congress of Biomedical Gerontology; Acapulco , Mexico : June 1989

[5]) Uebelhart D, Malaise M, Marcolongo R, DeVathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004;12:269-76

[6]) van Blitterswijk WJ, van de Nes JC, Wuisman PI. Glucosamine and chondroitin sulfate supplementation to treat symptomatic disc degeneration: biochemical rationale and case report. BMC Complement Altern Med. 2003;3(1):2

[7]) Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996;23(8):1385-91

[8]) Mazieres B, Combe B, Phan Van A, Tondut J, Grynfeltt M. Chondroitin sulfate in osteoarthritis of the knee: a prospective, double blind, placebo controlled multicenter clinical study. J Rheumatol. 2001;28(1):173-81

[9]) Morrison LM. Treatment of coronary arteriosclerotic heart disease with chondroitin sulfate-A: preliminary report. J Am Geriatr Soc. 1968;16(7):779-85

[10]) Morrison LM, Branwood AW, Ershoff BH, Murata K, Quilligan JJ Jr, Schjeide OA, Patek P, Bernick S, Freeman L, Dunn OJ, Rucker P. The prevention of coronary arteriosclerotic heart disease with chondroitin sulfate A: preliminary report. Exp Med Surg. 1969;27(3):278-89

[11]) Morrison LM, Bajwa GS. Absence of naturally occurring coronary atherosclerosis in squirrel monkeys (Saimiri sciurea) treated with chondroitin sulfate A. Experientia. 1972 Dec 15;28(12):1410-1

[12]) Morrison LM, Enrick N. Coronary heart disease: reduction of death rate by chondroitin sulfate A. Angiology. 1973 May;24(5):269-87

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