Suresh Kumar, Ramendra Pati Pandey*, Vijay K. Bharti, Nitika Sharma, Jay Bajarang Singh, Abhishek Chanchal and Saheem Ahmad


Nanoparticles used in different applications, including drug carrier systems, imaging and other biomedical uses. The large surface areas and high reactivity of nanoparticles make them potential targets for contamination with bacterial endotoxins (Paul and Kreyling, 2004; Jain et al., 2015). In addition, the nanoparticle interactions with platelets, coagulation factors and endothelial cells may all contribute to undesirable coagulation-mediated toxicities (Anna and Marina, 2013). The compatibility of administrated nanoparticles with components of the coagulation system depends on their physicochemical properties. Hence, the immunocompatibility is an important safety parameter for biomedical nanomaterial. Moreover, the endotoxin contamination can confound there results of safety screens for pharmaceutical products, causing false-positives for immunotoxicity; therefore, ideally, endotoxin should be accurately quantified in nanotechnology based drugs and devices prior to other safety evaluations (Mayer et al., 2009; Nel et al., 2009; Geraci et al., 2015). One of the common challenges in preclinical development of engineered nanomaterials is their interference with traditional in vitro tests (Dobrovolskaia et al., 2009; Dobrovolskaia et al., 2010). The high surface: volume ratios of nanoparticles may lead to high reactivity with proteins, enzymes and other biomolecules under physiological conditions, and can cause interference with Limulus amebocyte lysate (LAL) tests. As an alternative bioassay, in vitro macrophage activation test (MAT) as this test is recognized by the current pyrogen and endotoxin testing guidance as an acceptable alternative to the LAL test (US FDA, 2012). However, the applicability of this test is limited to nanoformulations that do not contain cytotoxic agents, since these inhibit endotoxin detection via this assay. Even a few studies also revealed that there is a correlation exit between MAT and RPT for nanomaterials. However, the appropriate method for detection of endotoxin is depending upon type of nanoformulations (Marina et al., 2013). Moreover; there will be need to develop alternative methods that may reliably detect endotoxin in nanoparticle samples when traditional methods cannot be used.

Keywords: Nanoparticels, Pyrogens, RPT, LAL, MAT.

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