Author(s): Neun BW, Dobrovolskaia MA
Monitoring endotoxin contamination in drugs and medical devices is required to avoid pyrogenic response and septic shock in patients receiving these products. Endotoxin contamination of engineered nanomaterials and nanotechnology-based medical products represents a significant translational hurdle. Nanoparticles often interfere with an in vitro Limulus Amebocyte Lysate (LAL) assay commonly used in the pharmaceutical industry for the detection and quantification of endotoxin. Such interference challenges the preclinical development of nanotechnology-formulated drugs and medical devices containing engineered nanomaterials. Protocols for analysis of nanoparticles using LAL assays have been reported before. Here, we discuss considerations for selecting an LAL format and describe a few experimental approaches for overcoming nanoparticle interference with the LAL assays to obtain more accurate estimation of endotoxin contamination in nanotechnology-based products. The discussed approaches do not solve all types of nanoparticle interference with the LAL assays but could be used as a starting point to address the problem. This chapter also describes approaches to prevent endotoxin contamination in nanotechnology-formulated products.
Referred From: https://dx.doi.org/10.1007/978-1-4939-7352-1_3
Author(s): Chin KL, Anis FZ, Sarmiento ME, Norazmi MN, Acosta A, et al.
Author(s): Negishi H, Taniguchi T, Yanai H
Author(s): Di Franco S, Turdo A, Todaro M, Stassi G
Author(s): Bessis N, GarciaCozar FJ, Boissier MC
Author(s): Sakurai H, Kawabata K, Sakurai F, Nakagawa S, Mizuguchi H, et al.
Author(s): Burel SA, Machemer T, Ragone FL, Kato H, Cauntay P, et al.
Author(s): Lennox KA, Behlke MA
Author(s): Leeds JM, Henry SP, Geary R, Burckin T, Levin AA, et al.
Author(s): Behlke MA
Author(s): Jacobi AM, Rettig GR, Turk R, Collingwood MA, Zeiner SA, et al.
Author(s): Neun BW, Dobrovolskaia MA
Author(s): Potter TM, Neun BW, Rodriguez JC, Ilinskaya AN, Dobrovolskaia MA, et al.
Author(s): Fennrich S, Hennig U, Toliashvili L, Schlensak C, Wendel HP, et al.
Author(s): Coch C, Luck C, Schwickart A, Putschli B, Renn M, et al.
Author(s): Daneshian M, Von Aulock S, Hartung T
Author(s): Dobrovolskaia MA
Author(s): Hasiwa N, Daneshian M, Bruegger P, Fennrich S, Hochadel A, et al.
Author(s): Hoffmann S, Peterbauer A, Schindler S, Fennrich S, Poole S, et al.
Author(s): Vessillier S, Eastwood D, Fox B, Sathish J, Sethu S, et al.
Author(s): Alvarez-Salas LM
Author(s): Henry SP, Geary RS, Yu R, Levin AA
Author(s): Holmlund JT, Monia BP, Kwoh TJ, Dorr FA
Author(s): Monteith DK, Henry SP, Howard RB, Flournoy S, Levin AA, et al.
Author(s): Evans DC, Watt AP, Nicoll-Griffith DA, Baillie TA
Author(s): Keefe AD, Pai S, Ellington A
Author(s): Schmidt A, Schwerd T, Hamm W, Hellmuth JC, Cui S, et al.