The focus on drug discovery has been shifted from the traditional small molecules to biologics and new modalities as a result of increasing research to address unmet medical needs. This evolution requires drug delivery technologies capable of carrying the drug intact to specific sites in the body and across cellular membranes to reach their targets. Engineered nanoparticles have emerged over the past decades as effective and customizable drug delivery platforms.
Due to the versatility of nanoparticulate systems they are defined broadly as materials engineered with at least one dimension or structure in the range of 1–100 nm or as particles with properties related to their nanoscale dimension, even if this dimension is up to 1 μm. In Ardena we define nanoparticles as having a size up to 200 nm. While the concept of entrapping the drug in nanoparticles has been known for many years, the increasing mechanistic understanding and constant advances in optimizing nanoparticulate drug delivery technologies for specific applications continues to accelerate the progress and use in drug product development .
Specific regulatory pathways to stimulate nanoparticle-based drug delivery systems have been drafted by regulatory authorities providing meaningful guidance for research, development, and manufacturing. With the outbreak of the pandemic, the successful development and emergency use of mRNA lipid nanoparticulate vaccines in record time was a quantum leap forward for nanoparticle drug delivery technology. This encouraged drug developers to intensify their investments in engineered nanoparticle delivery for innovative therapeutics approaches.
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