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Can Endotoxin Cause Immunogenicity?
Gram-negative bacterial lipopolysaccharide or endotoxin can be pyrogenic and/or cause immunogenicity.
Currently, only pyrogen testing is required for therapeutics and medical devices by the FDA.
Therapeutic proteins are known to generate neutralizing antibodies reducing drug efficacy.
Scientists at BioDtech, Inc. have measured previously undetectable levels of endotoxin which could cause activation of the immune system.
BioDtech, Inc. products are designed to more accurately detect endotoxin and remove it from proteins and DNA.
BioDtech, Inc. Product Information:
EndoBind-R™ is an affinity chromatography media designed to remove endotoxin from aqueous solutions. The ligand is highly specific for endotoxin resulting in high detoxification and low product loss.
EndoPrep™ is a sample preparation kit used in conjunction with traditional LAL or rFC assays. It removes the interfering effects of proteins that can mask endotoxin or inhibit enzymatic assays thus providing more accurate endotoxin quantitation.
For additional information, see the PDF of our technical notes detailing the use of the treatment kit in protein and peptide samples (EndoPrep Application Notes).
