Ambiguities in applying traditional Limulus amebocyte lysate tests to quantify endotoxin in nanoparticle formulations.
Ambiguities in applying traditional Limulus amebocyte lysate tests to quantify endotoxin in nanoparticle formulations.
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DOI:
10.2217/nnm.10.29
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发表时间:
2010-06
期刊:
影响因子:
--
通讯作者:
McNeil SE
中科院分区:
文献类型:
--
作者:
Dobrovolskaia MA;Neun BW;Clogston JD;Ding H;Ljubimova J;McNeil SE
Nanotechnology is finding increasing application in biology and medicine. As with other pharmaceutical formulations and medical devices intended for use in animals and human patients, contamination of nanoparticles with bacterial endotoxins should be thoroughly investigated before preclinical in vitro and in vivo characterization. Traditional methods to study endotoxin contamination include the in vitro quantitative limulus amoebocyte lysate test and the in vivo qualitative rabbit pyrogen test. Both of these tests have long history of use for traditional pharmaceuticals and medical devices and are routinely used in drug development. Here we report that nanoparticles often interfere with these traditional endotoxin detection tests and suggest approaches to detect and overcome such interferences.
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