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Information on Prions and Endotoxins
OviGenex products are harvested in Australia following GMP and ISO standards. Using our patented solution, CollOvine™ is harvested from lamb and sheep skin without any disruption to the structure of the collagen. We employ further proprietary techniques resulting in undetectable endotoxin levels, so that OviGenex can be classed as 99% pure Research and Pharmaceutical Grade Ovine Collagen.
As a result of strict sheep skin sourcing and our proprietary manufacturing processes, OviGenex products are certified to be 99% pure, prion free, soluble ovine collagen with undetectable endotoxin levels; in solution and powder formats making it suitable for medical and research applications.
WHAT ARE "PRIONS" AND PRION DISEASES?
According to the U.S. Centers for Disease Control (CDC), prion diseases or transmissible spongiform encephalopathies (TSEs), are a family of rare progressive neurodegenerative disorders that affect both humans and animals. They are distinguished by long incubation periods, characteristic spongiform changes associated with neuronal loss, and a failure to induce inflammatory response.
The causative agents of TSEs are believed to be prions. The term “prions” refers to abnormal, pathogenic agents that are transmissible and are able to induce abnormal folding of specific normal cellular proteins called prion proteins that are found most abundantly in the brain. The functions of these normal prion proteins are still not completely understood. The abnormal folding of the prion proteins leads to brain damage and the characteristic signs and symptoms of the disease. Prion diseases are usually rapidly progressive and always fatal.
WHY IS "PRION FREE" IMPORTANT?
Collagen is the major structural protein found in human connective tissue and is widely accepted as a safe and natural bio-material for the manufacture of a broad range of medical products.
As a result of the global epidemic known as "Mad Cow Disease”, there has been an urgency in finding a safe and acceptable collagen source that can replace the bovine collagen that is widely used.
Mad Cow Disease or Bovine Spongiform Encephalopathy (BSE) has been of great concern since 1986, when it was first reported among cattle in the U.K. At its peak 1,000 new cases per week were identified. Concern grows as new cases of BSE continue to be reported across the globe.
WHAT ARE ENDOTOXINS?
Endotoxin is a general term used for the more scientific term; Lipopolysaccharides. (LPS)
LPS is a molecule consisting of a lipid connected to many sugar molecules and is a component of the bacterial cell membrane.
Examples of Gram Negative Bacteria of Human importance:
1) E. coli along with other gram negative bacteria constitute approximately 40% of feces.
2) Pseudomonas, a bacteria that causes disease
3) Klebsiella, a bacteria that causes disease.
WHY ARE ENDOTOXINS A PROBLEM?
When the bacterium dies, or the cell wall is ruptured, the LPS is released, stimulating the human (or animal) immune system (i.e., white blood cells) to produce proteins in the body that can have an adverse effect on different organs.
For example, endotoxin can cause “septic shock”, in which blood vessels can become leaky and compromise the function of the heart. Different endotoxins from different gram-negative bacteria can compound the symptoms of the bacterial infection.