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The European Science Foundation has defined nanomedicine as “the science and technology of diagnosing, treating and preventing disease and traumatic injury, of relieving pain, and of preserving and improving human health, using molecular tools and molecular knowledge of the human body.” In contrast to the traditional medical fields, nanomedicine focuses its efforts specifically towards research and development on the nanoscale.
Nanotechnology applications in medicine have opened up the doors for enhanced diagnostic and treatment options for a number of biological diseases. Its unique ability to penetrate through various biological membranes including molecular, cellular, and organellar levels, is especially crucial in treating diseases that originate at these hard to reach locations.
These desirable characteristics of nanoparticles are inspiring to researchers who have found new and improved ways in treating detrimental biological diseases such as cancer.
The application of nanotechnology to medicine is still in its early stages, yet can already be found in various pharmaceutical drugs, polymeric coatings, and preclinical imaging.
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Safety and Quality of Nanomedicines
Despite its promise, there are still concerns about the safety and quality of these nanomedicines. The unique properties of nanoparticles such as high surface-to volume ratios, reactivity, and microscopic size, that prove useful in targeting biological diseases, are also of concern when understanding the safety of these products.
- If these particles are so microscopic that they can cross barriers of 100 nm in size, what is stopping them from traveling beyond their intended site(s) of treatment?
- What are the toxicokinetic properties of nanoparticles in the human body, and how can we ensure that they exhibit accurate and safe absorption, distribution metabolism, and excretion (ADME)?
- Does bioaccumulation of nanoparticles impose a bigger threat to human health than the diseases nanomedicines intend to treat?
Without the preliminary investigations that are necessary to ensure the safety of a product, nanomedicine advancements will continue to spark controversy. While the U.S. Food and Drug Administration has not published specific guidelines or requirements for the characterization of nanomedicines or other nanotechnology products, certain international organizations have taken it upon themselves to understand the complexity of this field.
Ensuring Nanomedicine Characterization
Launched on June 1, 2015, the European Nanomedicine Characterization Laboratory (EU-NCL), comprised of eight countries from the European Union, partnered with the Nanotechnology
Characterization Laboratory (US-NCL) of the U.S. National Cancer Institute to ensure nanomedicine characterization for future pharmaceutical products. In an effort to bring safe and beneficial nanomedicines into the clinic and on the market, the EU-NCL and US-NCL intends to provide trans-disciplinary testing that will allow for a comprehensive understanding of nanomedicines.
Through physical, chemical, in vitro and in vivo biological testing, these partnering institutions will allow researchers to gain a better understanding of the biodistribution, metabolism, pharmacokinetics, safety profiles and immunological effects of nanomedicine products.
The NCL evaluates nanomedicines using assay cascades that are tailored to the specific properties of nanomaterials in order to identify and address potential safety risks of the technology. Through this international and unified network, the EU-NCL and the US-NCL has provided the foundation for worldwide nanomedicine characterization that will provide the analytical resources to scientists in order to ensure the continuation of these advancements.
Bruker Corporation, one of the world’s leading analytical instrumentation companies, has also been a pioneer in nanomedicine characterization. Bruker offers different methods in order to shorten time-to-market by delivering earlier and more highly predictive data. These discoveries have been applied to fields such as cancer research, drug discovery and development, functional anatomical neuroimaging, orthopedics, cardiac imaging and stroke models.
The In-Vivo Xtreme system from Bruker is one such system that offers users the combination of sensitivity, speed and flexibility in molecular imaging. The system can be used for tracking and validating single or multimodal nanoparticles in areas such as drug discovery.
Malvern Instruments, located in Malvern, UK, is also a major characterization corporation that provides the materials and technology to enable scientists and engineers to understand properties of dispersed systems in all applicable industries. Malvern’s systems are used to measure particle size, shape, zeta potential, protein charge, molecular weight, mass, size and conformation, microcalorimetry, rheological properties and chemical identification, which are applied at all stages of research and product development. An example of this specified research is Malvern’s Nanoparticle Tracking Analysis (NTA), which utilizes properties such as light and motion of the particle, in order to analyze nanoparticle size and distribution of samples in liquid suspension. This method has been designed and formulated for therapeutic purposes in order to enhance the currently available drug delivery mechanisms.
Schematic of the optical configuration used in NTA. Image Credits: Malvern Instruments Ltd.
Nanotechnology, particularly in its medical applications, has provided new hope in the scientists’ war against the suffering imposed to humans by biological diseases. The process of nanomedicine characterization is an essential part of providing new cures and treatments, and without the proper research the adverse effects are incredibly worrisome. The lack of knowledge about how nanoparticles can affect or interfere with biological pathways and processes is a driving force in the development of safety regulations. The United States’ National Institute of Health (NIH) is evaluating several of these safety issues that include particle pathways, the length of time nanoparticles remain in the body, the effects particles have on cellular and tissue functions, access to systemic circulation, and unanticipated reactions in vivo.
As nanotechnology continues to advance around the world, characterization remains the most important part of its developmental process. There is a tremendous need for the cooperation of scientific communities and industries around the world, such as that exhibited between the EU-NCL and the US-NCL, to work together in this great endeavor of knowledge. Scientists and researchers are responsible to bridge any gaps that may hinder this process, and instead work towards the recognition of the profitable and harmful effects that nanotechnology, particularly nanomedicine, can have on human health.
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- Bruker In-Vivo Xtreme
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