Challenges Associated and Approaches for Successful Translation of Nanomedicines Into Commercial Products

Agrahari, Vivek; Hiremath, Praveen

doi:10.2217/nnm-2017-0039

Cited by 74 publications

(41 citation statements)

References 21 publications

(43 reference statements)

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“…They play a major role in the present and future perspectives of medicine with important contributions in the treatment of diseases such as cancer or as efficient antimicrobial agents. However, most nanotechnological products fail to become a commercially viable because of the lack of characterization, among other reasons . So, rapid and cheap methods such as ours may be applied for the adequate characterization of complex molecules and their future commercialization.…”

Section: Resultsmentioning

confidence: 99%

“…However, most nanotechnological products fail to become a commercially viable because of the lack of characterization, among other reasons. [54] So, rapid and cheap methods such as ours may be applied for the adequate characterization of complex molecules and their future commercialization. Although, in this study, we have evaluated the efficiency of the newly developed protocols with protein-based aggregates, the study of peptides and proteins in a wide plethora of presentations at nanoscale such as self-assembling nanoparticles, [14,52,[55][56][57] bioinspired proteosomes, [58,59] dendrimers, [60] micelles, [61,62] scaffolds, [63] nanocomposites, [3] Figure 3.…”

Section: Advantages and Disadvantages Of New Methodsmentioning

confidence: 99%

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Improving Biomaterials Imaging for Nanotechnology: Rapid Methods for Protein Localization at Ultrastructural Level

Cano‐Garrido

García‐Fruitós

Villaverde

et al. 2018

Biotechnology Journal

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The preparation of biological samples for electron microscopy is material- and time-consuming because it is often based on long protocols that also may produce artifacts. Protein labeling for transmission electron microscopy (TEM) is such an example, taking several days. However, for protein-based nanotechnology, high resolution imaging techniques are unique and crucial tools for studying the spatial distribution of these molecules, either alone or as components of biomaterials. In this paper, we tested two new short methods of immunolocalization for TEM, and compared them with a standard protocol in qualitative and quantitative approaches by using four protein-based nanoparticles. We reported a significant increase of labeling per area of nanoparticle in both new methodologies (H = 19.811; p < 0.001) with all the model antigens tested: GFP (H = 22.115; p < 0.001), MMP-2 (H = 19.579; p < 0.001), MMP-9 (H = 7.567; p < 0.023), and IFN-γ (H = 62.110; p < 0.001). We also found that the most suitable protocol for labeling depends on the nanoparticle's tendency to aggregate. Moreover, the shorter methods reduce artifacts, time (by 30%), residues, and reagents hindering, losing, or altering antigens, and obtaining a significant increase of protein localization (of about 200%). Overall, this study makes a step forward in the development of optimized protocols for the nanoscale localization of peptides and proteins within new biomaterials.

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Section: Resultsmentioning

confidence: 99%

Section: Advantages and Disadvantages Of New Methodsmentioning

confidence: 99%

Improving Biomaterials Imaging for Nanotechnology: Rapid Methods for Protein Localization at Ultrastructural Level

Cano‐Garrido

García‐Fruitós

Villaverde

et al. 2018

Biotechnology Journal

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“…Though, the evaluation of biological fate of EVs-nanoparticle systems will be critical for their successful translation since nanoparticles in vivo journey can be significantly affected by their physicochemical properties which may also impact the EVs fate. 99,100 All these evaluations should be made within the framework of a mature regulatory surveillance system that protects patients' safety, and avoids deviations into unproven mercantile clinical applications that would jeopardize the potential and future of EVs as proven therapies.…”

Section: Expert Opinion: Roadmap To Avoid Evs Being "Lost In Translatmentioning

confidence: 99%

<p>Extracellular Vesicles As Nanomedicine: Hopes And Hurdles In Clinical Translation</p>

Burnouf

Agrahari

2019

IJN

Self Cite

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The clinical development of cell therapies is revealing that extracellular vesicles (EVs) may become very instrumental as subcellular therapeutic adjuncts in human medicine. EVs are released by various types of cells, grown in culture, such as mesenchymal stromal cells, or obtained from patients or allogeneic donors. Some EV populations (especially species of exosomes and shed microvesicles) exhibit inherent roles in cell-cell communication, thanks to their ca. 30~1000-nm nanosize and the physiological expression of cellspecific markers on their lipid bilayer membranes. Biomedical engineers are now attempting to exploit this cellular crosstalk capacity to use EVs as smart drug delivery systems that display substantial benefits in targeting, safety, and pharmacokinetics compared to synthetic nanocarriers. In parallel, the development of a set of nano-instrumentation, biochemical tools, and preclinical assays needed for optimal characterization of both naïve and drugloaded EVs is ongoing. Although many hurdles remain, owing to the complexity of EV populations, translation of this "subcellular therapy" platform into reality is at hand and may soon change the landscape of the therapeutic arsenal in place to treat human degenerative and metabolic pathologies as well as diseases like cancer. This article provides objective opinions, balanced between unrealistic hopes of the capacity of EVs to resolve multiple clinical issues and concrete hurdles that have to be overcome to ensure that EVs are not lost in the translation phase, so that EVs can fulfill their promise by becoming a reliable therapeutic modality.

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“…This is a positive signal acknowledging major general advances of nanomaterials clinical translation. However, several challenges remain unanswered [2,[8][9][10]. Among them, the next important step in nanomedicine (NM) development is expected to come from the comprehension of their interactions with biological components encountered in vivo [11].…”

Section: Introductionmentioning

confidence: 99%

Characterization of nanomedicines’ surface coverage using molecular probes and capillary electrophoresis

Coty

Varenne

Benmalek

et al. 2018

European Journal of Pharmaceutics and Biopharmaceutics

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A faithful characterization of nanomedicine (NM) is needed for a better understanding of their in vivo outcomes. Size and surface charge are studied with well-established methods. However, other relevant parameters for the understanding of NM behavior in vivo remain largely inaccessible. For instance, the reactive surface of nanomedicines, which are often grafted with macromolecules to decrease their recognition by the immune system, is excluded from a systematic characterization. Yet, it is known that a subtle modification of NMs' surface characteristics (grafting density, molecular architecture and conformation of macromolecules) is at the root of major changes in the presence of biological components. In this work, a method that investigates the steric hindrance properties of the NMs' surface coverage based on its capacity to exclude or allow adsorption of well-defined proteins was developed based on capillary electrophoresis. A series of proteins with different molecular weights (MW) were used as molecular probes to screen their adsorption behavior on nanoparticles bearing different molecular architectures at their surface. This novel strategy evaluating to some degree a functionality of NMs can bring additional information about their shell property and might allow for a better perception of their behavior in the presence of biological components. The developed method could discriminate nanoparticles with a high surface coverage excluding high MW proteins from nanoparticles with a low surface coverage that allowed high MW proteins to adsorb on their surface. The method has the potential for further standardization and automation for a routine use. It can be applied in quality control of NMs and to investigate interactions between proteins and NM in different situations.

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Challenges Associated and Approaches for Successful Translation of Nanomedicines Into Commercial Products

Cited by 74 publications

References 21 publications

Improving Biomaterials Imaging for Nanotechnology: Rapid Methods for Protein Localization at Ultrastructural Level

Improving Biomaterials Imaging for Nanotechnology: Rapid Methods for Protein Localization at Ultrastructural Level

<p>Extracellular Vesicles As Nanomedicine: Hopes And Hurdles In Clinical Translation</p>

Characterization of nanomedicines’ surface coverage using molecular probes and capillary electrophoresis

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