Impact of Nanoparticle Sterilization on Analytical Characterization

Subbarao, Nanda

doi:10.1142/9789814390262_0003

Cited by 2 publications

(7 citation statements)

References 53 publications

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“…76 However it is more challenging and often impossible to remove endotoxin from ENMs because of adsorption to ENM surfaces. 68 , 75 Methods for endotoxin removal are specific to the type of nanoparticles because many ENMs do not tolerate traditional sterilization and depyrogenation methods. 41 , 68 , 75 …”

Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

“…Even ENMs intended for biomedical applications often fail in preclinical development due to endotoxin. For example, >30% of research-grade EMNs intended for biomedical applications contained endotoxin levels per dose above that mandated as acceptable by the U.S. Pharmacopoiea. , Endotoxin can also be introduced to sterile, pyrogen-free ENM during storage and handling, , and removing them from formulations may prove challenging due to their pH and temperature stability. They can be removed from an aqueous solution using a 10 000 MWCO or smaller ultrafiltration device or by anion exchange .…”

Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

“…They can be removed from an aqueous solution using a 10 000 MWCO or smaller ultrafiltration device or by anion exchange . However it is more challenging and often impossible to remove endotoxin from ENMs because of adsorption to ENM surfaces. , Methods for endotoxin removal are specific to the type of nanoparticles because many ENMs do not tolerate traditional sterilization and depyrogenation methods. ,, …”

Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

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Identification and Avoidance of Potential Artifacts and Misinterpretations in Nanomaterial Ecotoxicity Measurements

Petersen

Henry

Zhao

et al. 2014

Environ. Sci. Technol.

212

219

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Novel physicochemistries of engineered nanomaterials (ENMs) offer considerable commercial potential for new products and processes, but also the possibility of unforeseen and negative consequences upon ENM release into the environment. Investigations of ENM ecotoxicity have revealed that the unique properties of ENMs and a lack of appropriate test methods can lead to results that are inaccurate or not reproducible. The occurrence of spurious results or misinterpretations of results from ENM toxicity tests that are unique to investigations of ENMs (as opposed to traditional toxicants) have been reported, but have not yet been systemically reviewed. Our objective in this manuscript is to highlight artifacts and misinterpretations that can occur at each step of ecotoxicity testing: procurement or synthesis of the ENMs and assessment of potential toxic impurities such as metals or endotoxins, ENM storage, dispersion of the ENMs in the test medium, direct interference with assay reagents and unacknowledged indirect effects such as nutrient depletion during the assay, and assessment of the ENM biodistribution in organisms. We recommend thorough characterization of initial ENMs including measurement of impurities, implementation of steps to minimize changes to the ENMs during storage, inclusion of a set of experimental controls (e.g., to assess impacts of nutrient depletion, ENM specific effects, impurities in ENM formulation, desorbed surface coatings, the dispersion process, and direct interference of ENM with toxicity assays), and use of orthogonal measurement methods when available to assess ENMs fate and distribution in organisms.

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Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

Section: Synthesis or Procurement Of Enmsmentioning

confidence: 99%

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Identification and Avoidance of Potential Artifacts and Misinterpretations in Nanomaterial Ecotoxicity Measurements

Petersen

Henry

Zhao

et al. 2014

Environ. Sci. Technol.

212

219

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“…Ethylene oxide and gamma irradiation are also commonly used traditional methods that can be applied for both sterilization and depyrogenation. The main limitation of these methods is that many polymer-based nanoparticles do not tolerate ethylene oxide, and some nanoparticles ( e.g ., silver colloids) do not withstand gamma irradiation [44–46]. …”

Section: Challenges and Considerationsmentioning

confidence: 99%

“…The major challenge in immunological characterization is related to the nanoparticle contamination with endotoxin [18, 27, 32–44]. Other immunology/hematology challenges include sterilization and depyrogenation of nanomaterials [43, 45, 46], as well as the in vitro–in vivo correlation between common immunotoxicity tests [47–49]. Some challenges overlap in all areas of pre-clinical characterization.…”

Section: Introductionmentioning

confidence: 99%

Pre-clinical immunotoxicity studies of nanotechnology-formulated drugs: Challenges, considerations and strategy

Dobrovolskaia

2015

Journal of Controlled Release

160

126

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Assorted challenges in physicochemical characterization, sterilization, depyrogenation, and in the assessment of pharmacology, safety, and efficacy profiles accompany preclinical development of nanotechnology-formulated drugs. Some of these challenges are not unique to nanotechnology and are common in the development of other pharmaceutical products. However, nanoparticle-formulated drugs are biochemically sophisticated, which causes their translation into the clinic to be particularly complex. An understanding of both the immune compatibility of nanoformulations and their effects on hematological parameters is now recognized as an important step in the (pre)clinical development of nanomedicines. An evaluation of nanoparticle immunotoxicity is usually performed as a part of a traditional toxicological assessment; however, it often requires additional in vitro and in vivo specialized immuno- and hematotoxicity tests. Herein, I review literature examples and share the experience with the NCI Nanotechnology Characterization Laboratory assay cascade used in the early (discovery-level) phase of pre-clinical development to summarize common challenges in the immunotoxicological assessment of nanomaterials, highlight considerations and discuss solutions to overcome problems that commonly slow or halt the translation of nanoparticleformulated drugs toward clinical trials. Special attention will be paid to the grandchallenge related to detection, quantification and removal of endotoxin from nanoformulations, and practical considerations related to this challenge.

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Impact of Nanoparticle Sterilization on Analytical Characterization

Cited by 2 publications

References 53 publications

Identification and Avoidance of Potential Artifacts and Misinterpretations in Nanomaterial Ecotoxicity Measurements

Identification and Avoidance of Potential Artifacts and Misinterpretations in Nanomaterial Ecotoxicity Measurements

Pre-clinical immunotoxicity studies of nanotechnology-formulated drugs: Challenges, considerations and strategy

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