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Safety Assessment
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Mary McElroy, PhD, Clive Roper

What's Hot in 2021: 3D Models and Nanovectors

How nano-sized vesicles and 3D-derived tissue models are influencing drug development

Extracellular Vesicles – Cell Dust to Star Dust? 

Extracellular vesicles (EVs) are small double-layered phospholipid vesicles, loaded with biologically active What's Hot logo: Nanoparticles and 3D modelsmolecules, that form an advanced communication system between cells. They were discovered some time ago and thought to be biologically inert or cell dust. Today however, EVs are seen as a safer form of cell-based therapies since they are unable to replicate and can be manufactured with greater uniformity. Phase 1 clinical trials have begun with EVs from mesenchymal cells and available data show they are well tolerated. Of course there are many challenges with a new therapies starting with the name (i.e. exosomes, micro-vesicles) and characterisation (i.e. size, composition). Also there are lots of unknowns around the molecular mechanisms governing release from donor cells and uptake by recipient cells; all these processes will need to be better described to move new therapies to patients. However, the potential to mimic a endogenous communication system to better target therapies ,while limiting harmful side effects, is reflected in the exponential growth in research articles and interest in their healing potential. 

Mary McElroy, PhD, Associate Director, Regulatory ADME & Discovery Sciences, Charles River

The use of 3D tissues will grow exponentially 

The use of human derived 3D tissue models (e.g. EpiThelix MucilAir and MatTek EpiOcular) have resulted in a revolution in toxicity and efficacy testing. Clinical, consumer and occupational testing scenarios can be simply evaluated screening out or even replacing animal tests. These biological models are being incorporated into engineering micro-physiological (a.k.a. organ-on-a-chip) technologies producing even more human relevant data for regulatory and scientific testing. The appearance of diseased-tissue derived models will accelerate finding new and improved treatments of diseases. With regulatory agencies in Europe and North America already seeking data from these models for acute toxicity, we can expect that the use of these 3D tissues will grow exponentially. Integration of these and traditional testing methods should reduce the costs of bringing products to market.

Clive Roper, PhD, Director, In Vitro Toxicology, Charles River