Nanotechnology: The Future of Medicine?

Fig 1. Size comparison of nanoparticles

An Overview

Nanomedicine uses the properties developed by a material at its nanometric scale which often differ in terms of physics, chemistry or biology from the same material at a bigger scale.

Fig 2. A closer look of a nanoparticle

How It Works (Emphasis on Cancer Treatment)

Challenges in the Industry

The clinical translation of nanomedicines is an expensive and time-consuming process. Nanomedicine technology is usually far more complex in comparison to conventional formulation technology containing a free drug dispersed in a base (e.g., tablets, capsules and injections). Key issues include biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of nanomedicines on the market, irrelevant of whether they are therapeutically effective or not.

Biological Challenges

Traditionally, nanomedicine development has been based on a formulation-driven approach, whereby novel delivery systems are firstly engineered and characterized from a different perspective. It is only when attempting to align the nanomedicine with a pathological application that limitations in the clinical translation of the system have been identified. Understanding the relationship between biology and technology, including understanding the influence of disease pathophysiology on nanomedicine accumulation, distribution, retention and success, as well as the biopharmaceutical correlation between delivery system properties and behavior in animals versus humans are important determinants for the successful translation of nanomedicines. Therefore, applying a disease-driven approach by designing and developing nanomedicines that are able to exploit pathophysiological changes in disease biology has been suggested to improve clinical translation.

Large-Scale Manufacturing

One of the important factors contributing to the slow pace in the clinical translation of nanomedicines is the structural and chemical complexity of the formulation itself. Platforms that require complex and/or laborious synthesis procedures generally have limited clinical translation potential, as they can be quite problematic to pharmaceutically manufacture on a large-scale. Pharmaceutical manufacturing development is centered on quality and cost. Quality includes the manufacturing process and stability of the formulation, with nanomedicine manufacturing being challenged by potential issues related to: poor quality control, incomplete purification from contaminants (e.g., by-products and starting materials), high material and/or manufacturing costs, low production yield, and scarcity of venture funds and pharmaceutical industry investment.

Biocompatibility Safety

Detailed toxicology is essential for the clinical translation nanomedicines to determine the overall safety for human use. Pharmaceutical regulatory authorities generally recommend that the sponsor carefully assess for any changes in the drug substance and drug product manufacturing process or drug product formulation at any phase of clinical development, in order to determine if the changes can directly or indirectly affect the safety of the product. If any changes are identified, strict procedures are in place to ensure appropriate comparison testing of the drug substance and/or drug product produced from the previous manufacturing process with the changed manufacturing process to evaluate product equivalency, quality, and safety. When analytical data demonstrate that the materials manufactured before and after are not comparable, sponsors should perform additional qualification and/or bridging studies to support the safety and bioavailability of the material to be used in the proposed trials.

Intellectual Property (IP)

Given the complexities of incorporating nanotechnology into biomedical and clinical applications, there needs to be more precise definitions on what constitutes novel IP of a nanomedicine. Nanomedicines are complex as they have a number of variable components, and bridge between the field of medicine and medical device. Generally, the control of a nanomedicine product requires an IP position on: the encapsulated cargo, the carrier technology, and the characteristics of the drug and carrier together. Although this definition is straightforward, it does open up a number of problems with the issuing of patents to date.

Conclusion

In this article, I talked about what nanomedicines are and what their various implications can be. In short, they can be used to enhance the effectiveness of medicine, especially when it comes to cancer treatments. However, there are also various challenges in this industry, ranging from cost to biocompatibility. All in all, nanomedicine has a bright future ahead of itself, and through further research and development, more and more breakthroughs will be sourced thus leading to the eventual common use of nanomedicines in everyday life. I hope this article gave you a better insight on the future of nanomedicines and how it can change the world.

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Akash Patel

Akash Patel

Innovator | Thinker | Creator. Passionate about medicine and its nanotechnological implications. Working on executing an idea. Website: akashapatel.com