Challenges in Development of Nanoparticle-Based Therapeutics
Open accessAbstract
In recent years, nanotechnology has been increasingly applied to the area of drug development. Nanoparticle-based therapeutics can confer the ability to overcome biological barriers, effectively deliver hydrophobic drugs and biologics, and preferentially target sites of disease. However, despite these potential advantages, only a relatively small number of nanoparticle-based medicines have been approved for clinical use, with numerous challenges and hurdles at different stages of development. The complexity of nanoparticles as multi-component three dimensional constructs requires careful design and engineering, detailed orthogonal analysis methods, and reproducible scale-up and manufacturing process to achieve a consistent product with the intended physicochemical characteristics, biological behaviors, and pharmacological profiles. The safety and efficacy of nanomedicines can be influenced by minor variations in multiple parameters and need to be carefully examined in preclinical and clinical studies, particularly in context of the biodistribution, targeting to intended sites, and potential immune toxicities. Overall, nanomedicines may present additional development and regulatory considerations compared with conventional medicines, and while there is generally a lack of regulatory standards in the examination of nanoparticle-based medicines as a unique category of therapeutic agents, efforts are being made in this direction. This review summarizes challenges likely to be encountered during the development and approval of nanoparticle-based therapeutics, and discusses potential strategies for drug developers and regulatory agencies to accelerate the growth of this important field.
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EVs offer advantages over traditional nanocarriers: their natural origin and biocompatibility reduce the risk of immune reactions and toxicity.
“On the other hand, EVs offer several advantages over traditional nanocarriers. Their natural origin and biocompatibility reduce the risk of immune reactions and toxicity [53].”
From Extracellular vesicles as nanotheranostic platforms for targeted neurological disorder interventions (2024) · cites this paper as [53]
The “Immunological Challenges of Nanomedicines” section describes immune reactions and toxicities associated with nanoparticles. It does not discuss EVs or establish that their natural origin and biocompatibility reduce those risks relative to traditional nanocarriers. (LLM, conf=0.82)
Experimental — accuracy not yet measuredApplication of nanomaterials is hindered by non-specific cytotoxicity and suboptimal biocompatibility, which can trigger adverse immune responses.
“Non-specific cytotoxicity, arising from unintended interactions with non-target cells, and suboptimal biocompatibility, which can trigger adverse immune responses, are among the primary concerns [53, 228].”
From Extracellular vesicles as nanotheranostic platforms for targeted neurological disorder interventions (2024) · cites this paper as [53]
The “Immunological Challenges of Nanomedicines” section (page not provided) supports the concern about adverse immune responses, including complement activation and hypersensitivity reactions. It also describes nanoparticle damage to erythrocytes, but does not establish non-specific cytotoxicity from unintended interactions with non-target cells as a general primary concern. (LLM, conf=0.82)
Experimental — accuracy not yet measuredEnsuring that nanoparticles are biocompatible and biodegradable can minimize long-term accumulation and reduce cytotoxicity in neural tissues.
“Ensuring that NPs are biocompatible and biodegradable can minimize long-term accumulation and reduce cytotoxicity in neural tissues. Commonly used materials such as PLGA and chitosan degrade into non-toxic byproducts, reducing these risks [201].”
From Targeted Nanoparticles for Drug Delivery Across the Blood–Brain Barrier in Early and Late Stages of Alzheimer's Disease: A Review (2026) · cites this paper as [201]
The 'Safety Challenges in Nanomedicine Development' section (page unavailable) identifies prolonged tissue persistence as a safety concern and contrasts it with rapid elimination. It does not establish that biocompatible, biodegradable nanoparticles reduce cytotoxicity in neural tissue, or that PLGA and chitosan degrade into non-toxic byproducts. (LLM, conf=0.78)
Experimental — accuracy not yet measuredNanoparticles are addressing the blood-brain barrier challenge by employing mechanisms such as receptor-mediated transcytosis and adsorptive-mediated transcytosis to facilitate drug transport across the barrier.
“NPs are addressing this challenge by employing mechanisms such as RMT and AMT to facilitate drug transport across the BBB [201].”
From Targeted Nanoparticles for Drug Delivery Across the Blood–Brain Barrier in Early and Late Stages of Alzheimer's Disease: A Review (2026) · cites this paper as [201]
The Biological Barriers to Drug Delivery section says nanoparticle strategies are under development to deliver drugs across the blood–brain barrier. It does not identify receptor-mediated or adsorptive-mediated transcytosis as mechanisms for that delivery; its discussion of receptor-linked transcytosis concerns the blood–tumor barrier instead. No page number is available in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSubtle changes in process or composition can adversely affect the complex composition of nanomedicines.
“Subtle changes in process or composition can adversely affect the complex composition of nanomedicines 142,143 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [142]
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- Authors
- Desai, N.
- Affiliations
- Abraxis (United States) (US)
- Corresponding author
- Desai, Neil
- Venue
- The AAPS Journal
- Published
- 2012-03-10
- Volume
- 14
- Issue
- 2
- Pages
- 282-295
- ISSN
- 1550-7416 (ISSN-L)
- PMC
- PMC3326161
- OpenAlex
- W2042249858
- Cited by
- 1,173
- References
- 89
- Citations by year
- 2026: 158 · 2025: 207 · 2024: 134 · 2023: 83 · 2022: 64 · 2021: 59 · 2020: 76 · 2019: 63 · 2018: 75 · 2017: 66 · 2016: 57 · 2015: 53 · 2014: 50 · 2013: 19 · 2012: 8
- FWCI
- 2.15
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The AAPS Journal (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Celgene
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Drug Discovery › Pharmacology and Nanomedicine Research
- Keywords
- nanotherapeutics, nanomedicine development, drug delivery, hydrophobic drug delivery, targeted drug delivery, nanoparticle engineering, nanomedicine safety, tissue distribution, immunotoxicity, regulatory standards, drug approval
- MeSH terms
- Animals, Pharmaceutical Preparations, Humans, Tissue Distribution, Drug Delivery Systems, Nanomedicine, Nanoparticles, Drug Discovery
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