I was going to tell a joke about nanoparticles, but it got lost in the details…
In the world of pharmaceuticals and biopharmaceuticals, small is the new mighty. Nanoparticles – engineered materials ranging from 1 to 100 nanometers in size – are revolutionising drug delivery, diagnostics, and treatment efficacy. Despite their minuscule size, their impact is anything but negligible. However, with great innovation comes great responsibility, and the regulatory landscape for nanoparticles in medicine is as intricate as the science itself.
Nanoparticles in drug delivery: a tiny uprising
One of the most promising applications of nanoparticles in pharma is their use in targeted drug delivery. Traditional drug formulations often suffer from poor bioavailability, systemic toxicity, and off-target effects. Nanoparticles address these challenges by:
- Enhancing solubility – many drugs, particularly in oncology, are hydrophobic (poorly water-soluble). Nanocarriers like liposomes, polymeric nanoparticles, and lipid nanoparticles (LNPs) improve solubility and absorption.
- Controlled release – nanoparticles can be designed to release drugs at a specific rate, extending therapeutic effects and reducing dosing frequency.
- Targeted therapy – functionalised nanoparticles can carry drugs directly to cancer cells, inflamed tissues, or specific organs, minimising damage to healthy cells. mRNA vaccines, including COVID-19 vaccines, use lipid nanoparticles (LNPs) for precise delivery into cells.
- Crossing biological barriers – nanoparticles can cross the blood-brain barrier, enabling treatments for neurological diseases like Alzheimer’s and Parkinson’s that were previously inaccessible.
Regulatory hurdles: a "nano-sized" challenge
Despite their promise, nanoparticle-based drugs face complex regulatory scrutiny. Since nanoparticles alter drug behaviour at a fundamental level, regulators assess safety, efficacy, and manufacturing more stringently. Some key regulatory considerations include:
1. Defining "nano"
- The FDA, EMA (European Medicines Agency), and ICH (International Council for Harmonisation) have varying definitions for what qualifies as a nanomedicine.
- The FDA’s Nanotechnology Task Force evaluates whether a product’s properties change significantly at the nanoscale.
2. Safety & toxicity
- Nano-drugs may accumulate in unintended organs, requiring advanced toxicological studies.
- Immunogenicity (unwanted immune reactions) is a concern, especially with LNP-based vaccines.
- Regulators demand detailed characterisation of nanoparticle size, shape, surface charge, and behaviour in the body.
3. Manufacturing & quality control
- Unlike conventional drugs, nanoparticles require highly specialised production techniques.
- The FDA’s cGMP (Current Good Manufacturing Practices) ensures nanoparticle formulations are consistent batch-to-batch.
- Stability and shelf-life testing must account for nano-specific degradation risks.
Nanomedicines on the market: success stories
Several FDA and EMA-approved nanoparticle-based drugs are already making waves in medicine:
- Doxil® (liposomal doxorubicin) – A liposome-encapsulated chemotherapy that reduces heart toxicity.
- Abraxane® (albumin-bound paclitaxel) – A nano-formulation of paclitaxel for breast and lung cancer.
- Comirnaty® (Pfizer-BioNTech COVID-19 Vaccine) – The first mRNA vaccine utilising lipid nanoparticles for intracellular delivery.
The future: small Tech, big potential
The future of nanoparticles in biopharma is expanding rapidly, with research focused on:
- Gene therapy & CRISPR delivery using nanoparticles to edit faulty genes.
- Personalised medicine, where nano-carriers are tailored to an individual’s genetic profile.
- Smart nanoparticles that respond to biological signals, releasing drugs only when needed.
Let’s hope this blog on nanoparticles has “sunk in”…
Nanoparticles may be small, but their role in pharmaceuticals and biopharma is monumental. As regulatory frameworks evolve, ensuring safety without stifling innovation will be crucial. From targeted cancer treatments to mRNA vaccines, nanoparticles are reshaping medicine at the tiniest scale possible – and that’s no small feat. Find out more with our new, fascinating course The Applications of Nanoparticles in the Pharmaceutical and Biomedical Industries
Published on May 19, 2025 by Ella Thomas