Gelatin and collagen are Generally Recognized As Safe (GRAS) by the US Food and Drug Administration (US FDA) and compliant with the US, European, and Japanese Pharmacopeia. But the use of traditionally manufactured gelatin and collagen - even of pharmaceutical and medical grades - in sensitive (bio)medical applications is challenged by the presence of endotoxins.
What are endotoxins?
Endotoxins or lipopolysaccharides are large, highly immunogenic molecules and the major component of the outer membrane of Gram-negative bacteria. For specific in-body biomedical applications, endotoxin limits have been defined to ensure patient safety. Complying with the limit values for endotoxins in these applications is a challenge: the endotoxin levels in traditionally manufactured gelatin and collagen are typically >100 times higher than those recommended by the United States’ Food and Drug Administration (USFDA), for example.
The importance of low endotoxin levels for in-body applications and research
For in-body applications, even at low levels, endotoxins can pose a serious health risk. When exposed to the immune system, endotoxins initiate an immune response that can lead to tissue inflammation, increased sensitivity to other allergens, and the risk of fatal shock (Weil and Spink, 1957).
When it comes to pharma and medical research, working with low endotoxin or endotoxin-free materials is crucial. Low-endotoxin materials will create more effective manufacturing and research possibilities. For example, research have already shown improved cell viability and differentiation in endotoxin purified cell growth environment. Pharma and medical developers are continually developing finding more and new used for gelatin and collagen- based applications both human and veterinary.
The X-Pure product range offers gelatins and collagens with extremely low endotoxin levels, consistent quality and traceability to the source for a wide range of applications.