Products

Ever since the pharmaceutical industry began manufacturing injectables, pyrogen detection tests have been an absolute necessity. Pyrogens are substances that can cause fever, shock and even death if high levels are intro­duced into a person’s body.

 Removal of endotoxin is one of the most difficult downstream processes during manufacturing of biopharmaceutical products. Many commercially available products are unable to adequately remove endotoxin, or require time consuming laboratory based analytics and incubation steps. In many cases, complete endotoxin removal is only achieved with unacceptable product loss.

There has been an unmet need for an assay that is fast, specific, accurate and reliable for endotoxin detection and quantitation, in the field of pyrogen testing. The assays that are currently accepted by the FDA and pharmacopeias worldwide are based on Limulus (horseshoe crab) amebocyte lysate (LAL) clotting in response to endotoxin. This assay lacks specificity because it reacts with glucans associated with yeast; the accuracy is ± 50% and requires specific conditions for a delicate enzymatic reaction to occur. In addition, LAL requires the harvesting of wildlife species.

To circumvent these problems, our analytics development team has synthesized peptides based on endotoxin binding sites. This is the basis for Avanti NanoSciences’ technology for the detection, neutralization and removal of endotoxin from biopharmaceutical ingredients, processes and products.

The synthetic peptide is attached to NanoBindi-a brightly fluorescent nanoparticle with a core shell architecture, coupled to a support for removal or added directly to a sample for neutralization. The synthetic peptide has a high affinity and specificity for endotoxin which approaches that of the natural molecule without reactivity with glucans. It also allows a broad range of assay conditions unlike other methods which increases accuracy and reliability. Using the spot arrays, the detection and quantization of the endotoxins can be completed in minutes. The rapid, near real-time detection capability makes it ideally suited for real-time monitoring of pharma grade ingredients especially water.

Avanti NanoSciences offers following products for a comprehensive endotoxin management for the drug development life cycle.

                 EndoSense^TM – detection and quantitation of        

                    endotoxins

        EndoStrip^TM – removal of endotoxins

•   EndoStrip^TM NA- removal of endotoxins from gene based therapeutics

•   EndoStrip^TM PR – removal of endotoxins from protein based therapeutics

•   EndoStrip^TM G   - a general purpose endotoxin removal from medical devices and manufacturing equipment

                  EndoMon^TM - Endotoxin Monitoring