Preclinical Characterization of Engineered Nanoparticles Intended for Cancer Therapeutics

Stern, Stęphan T.; McNeil, Scott E.; Patri, Anil K.; Dobrovolskaia, Marina A.

doi:10.1201/9781420006636.ch7

Cited by 10 publications

(3 citation statements)

References 148 publications

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“…Due to the disrupting complexity of nano formulations, traditional approaches for medicine regulation cannot be applied without a significant adaptation to the nature of the pharmaceutical object [104,105]. The emergence of the field of Nanomedicine brings a huge deal for a renewed regulatory process.…”

Section: General Strategies For Nanomedicine Characterization and Today's Recommendations Of Health Authorities Ii1 The Characterization mentioning

confidence: 99%

Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success

Coty

Vauthier

2018

Journal of Controlled Release

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The nanotechnology revolution offers many expectations for the improvement of medicine treatments. At present, nanomedicine (NM) development is hampered by methodological barriers for a better characterization and a wider understanding of their in vivo behavior. While regulatory agencies setup guidelines to support NM translation from bench to bedside, the gap is still hardly overcome by main nanomedicines. One lever for filling this gap is a better characterization, thus increasing the global knowledge about the NM itself but also validate the confidence in terms of batch to batch reproducibility of such complex nano-objects. Here, we review the current methodologies routinely used for clinical release of nanomedicine batches in compliance with official guidelines. We confront them to the extreme sharpness of biological systems and finally discuss future possible orientations for a better characterization of NMs, needed to bridge the gap between physicochemical properties and biological fate.

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Section: General Strategies For Nanomedicine Characterization and Today's Recommendations Of Health Authorities Ii1 The Characterization mentioning

confidence: 99%

Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success

Coty

Vauthier

2018

Journal of Controlled Release

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“…After this, the particles are dried under a mercury lamp and observed under a monochromatic beam of electrons penetrating the sample and generating an image. Small particles can be observed, and the crystallographic structure of a sample can be imaged at an atomic scale 26,27 . Lin-Al-Tai et, al.…”

Section: Transmission Electron Microscopy (Tem)mentioning

confidence: 99%

Untitled

2023

IJPSR

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Nanotechnology has found its way into most science fields at a tiny scale. Particle of this size and molecules were found to work differently and got diverse applications. Novel drug delivery system leads to the development of Nanocarriers, including Nanoparticles, Nanospheres, Nano capsules, Nano emulsion, liposomes, and Niosomes. The major area for research is to design Nanoparticles that can efficiently manage particle size, surface properties, and drug release. For this to get characterizations of Nanoparticles, it is critical to control their desired invitro and in-vivo behavior. Nanoparticles are characterized by their size, surface morphology, and surface charge, using highly advanced microscopic techniques. Colloidal stability is ascertained through zeta potential. Nanoparticles are also characterized by polymer and drug interaction. In-vivo characterization for binding and internalization of targeted carriers to the specific cell and bio distribution study of targeted Nanoparticles could also be confirmed using confocal microscopy. This review covers all the aspects related to the characterization of the pharmaceutical Nanoparticle.

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“…Considering the animal species, a much more realistic and predictive measure of the effect of the compound is created and can capture the complexity of target engagement, metabolism, and pharmacokinetics required in the therapeutic drug [231]. They should include the effects of particles on various organs and systems, such as the liver, heart, kidney, and immune system [232].…”

Section: In Vivo Testsmentioning

confidence: 99%

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

et al. 2022

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Nanomedicine plays an essential role in developing new therapies through novel drug delivery systems, diagnostic and imaging systems, vaccine development, antibacterial tools, and high-throughput screening. One of the most promising drug delivery systems are nanoparticles, which can be designed with various compositions, sizes, shapes, and surface modifications. These nanosystems have improved therapeutic profiles, increased bioavailability, and reduced the toxicity of the product they carry. However, the clinical translation of nanomedicines requires a thorough understanding of their properties to avoid problems with the most questioned aspect of nanosystems: safety. The particular physicochemical properties of nano-drugs lead to the need for additional safety, quality, and efficacy testing. Consequently, challenges arise during the physicochemical characterization, the production process, in vitro characterization, in vivo characterization, and the clinical stages of development of these biopharmaceuticals. The lack of a specific regulatory framework for nanoformulations has caused significant gaps in the requirements needed to be successful during their approval, especially with tests that demonstrate their safety and efficacy. Researchers face many difficulties in establishing evidence to extrapolate results from one level of development to another, for example, from an in vitro demonstration phase to an in vivo demonstration phase. Additional guidance is required to cover the particularities of this type of product, as some challenges in the regulatory framework do not allow for an accurate assessment of NPs with sufficient evidence of clinical success. This work aims to identify current regulatory issues during the implementation of nanoparticle assays and describe the major challenges that researchers have faced when exposing a new formulation. We further reflect on the current regulatory standards required for the approval of these biopharmaceuticals and the requirements demanded by the regulatory agencies. Our work will provide helpful information to improve the success of nanomedicines by compiling the challenges described in the literature that support the development of this novel encapsulation system. We propose a step-by-step approach through the different stages of the development of nanoformulations, from their design to the clinical stage, exemplifying the different challenges and the measures taken by the regulatory agencies to respond to these challenges.

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Preclinical Characterization of Engineered Nanoparticles Intended for Cancer Therapeutics

Cited by 10 publications

References 148 publications

Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success

Characterization of nanomedicines: A reflection on a field under construction needed for clinical translation success

Untitled

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

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