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Article
Instruments & Instrumentation
Antje Vennemann et al.
Summary: The study developed an imaging strategy for the label-free detection of PEBCA particles using a combination of DFM, CRM, and ToF-SIMS. The strategy successfully imaged PEBCA particles and identified PEBCA-loaded cells in NR8383 cells.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Melissa Anne Tutty et al.
Summary: Despite the wide applications of nanobiomaterials (NBMs) in human health, their translation from lab to clinic is slow due to liver accumulation and toxicity. The commonly used in vitro and in vivo methods are insufficient in predicting NBM hepatotoxicity, posing a significant challenge. This review discusses the relationship between NBMs and the liver, limitations of toxicity assessment methods, recent advancements in tissue-mimetic 3D cell models, and the low public acceptance and limited uptake of these models.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Jordi Minnema et al.
Summary: The use of nanobiomaterials in medicine is gaining popularity. This study implemented and parametrized a physiologically based pharmacokinetic (PBPK) model to better understand the biodistribution of two nanobiomaterials in rats. The results showed significant kinetic differences between the two materials, highlighting the need for tailored parametrization of PBPK models. These findings contribute to the establishment of a comprehensive database for predictive biodistribution modeling.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Alex Zabeo et al.
Summary: The application of nanomaterials in medicine has great potential, but the translation of these technologies to clinical practice faces challenges. To support the development and clinical implementation of nanotechnology-enabled health products, the REFINE project has developed a Decision Support System (DSS) to assist developers in preclinical assessment and intelligent testing, improving efficiency.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Valeria Perugini et al.
Summary: The development of drug nanocarriers has enabled precision medicine, but a specific regulatory framework is needed to ensure safety and reliability. This study proposes a multistep protocol to evaluate the hemocompatibility of nanocarriers, demonstrating sensitivity and reproducibility.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Maiara Camotti Montanha et al.
Summary: This study developed a novel mechanistic and physiologically based pharmacokinetic (m-PBPK) model to predict the biodistribution of nanoparticles. By considering factors such as stability, permeability, and cellular uptake, the model successfully simulated the behavior of Doxil nanoparticles in both rats and humans.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Andreas K. O. Aslund et al.
Summary: The biodistribution of nanoencapsulated bioactive compounds is primarily influenced by the size, shape, chemical composition, and surface properties of the encapsulating nanoparticles. This study compared the biodistribution profiles of two clinically relevant nanoformulations in healthy rats. The results showed significant differences in biodistribution, suggesting potential therapeutic applications in lung and brain cancer for these nanoformulations.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Melissa Anne Tutty et al.
Summary: Due to their unique properties, nanobiomaterials are extensively studied for medical and drug delivery applications. However, their small size also makes them susceptible to toxicity. While the immunotoxicity and cytotoxicity of nanomaterials have been well studied, there is limited data on their genotoxicity or ability to cause DNA damage. In recent years, there has been increased attention to genotoxicity screening of nanomaterials due to new medical device regulations. Through an interlaboratory comparison study, the alkaline comet assay was found to be a suitable method for assessing nanobiomaterial-induced DNA damage.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Rob J. Vandebriel et al.
Summary: Nanoparticles, including nanomedicines, interact with the immune system and affect immune mechanisms like NLRP3 inflammasome activation and DC maturation. Two nanomedicines were evaluated for their effects on these mechanisms, and inter-laboratory comparison demonstrated reproducible results.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Kai Moritz Eder et al.
Summary: This study confirmed the suitability and reproducibility of a cytotoxicity matrix consisting of two endpoints performed with four cell lines across three partner laboratories. The experiments showed that Liplmage (TM) 815 lipidots (R) were non-cytotoxic up to a concentration of 128 μg/mL, while poly(alkyl cyanoacrylate) (PACA) nanoparticles for drug delivery had dose-dependent cytotoxic effects on cell lines starting from 8 μg/mL. These findings provide valuable information for the development of organic nanomaterials used in medicine.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Wim H. De Jong et al.
Summary: Nanotechnologies offer great opportunities for innovative medicines, but safety evaluation methods are lagging behind. The specific properties of nanomedicines hinder their safety evaluation and require special attention to the adverse effects on the immune system. This special issue provides valuable knowledge to address regulatory challenges and gaps in testing methods for the safety evaluation of nanomedicines.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Anne Marzi et al.
Summary: Digital holographic microscopy (DHM) is a fast, label-free, and interference-free method for evaluating the toxicity of nanomaterials. In a comparative study conducted at two laboratories, we confirmed the repeatability and reproducibility of DHM as a tool for assessing the cytotoxicity of nanomaterials.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Blanka Halamoda-Kenzaoui et al.
Summary: The identification of regulatory challenges for nanotechnology-enabled health products is crucial, and greater collaboration between regulatory and research communities is needed to support regulatory decision-making with academic data. Through cross-sector workshops, common and sector-specific challenges can be identified and solutions can be discussed.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Instruments & Instrumentation
Melissa Anne Tutty et al.
Summary: Nanobiomaterials (NBMs) have wide applications in medicine and bioimaging, but evaluating their safety, especially their impact on the liver, is a challenge. Current pre-clinical methods cannot accurately predict liver toxicity of NBMs. 3D cell culture models provide a more accurate assessment of NBM-tissue interaction.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Review
Chemistry, Multidisciplinary
B. Halamoda-Kenzaoui et al.
Summary: Nanotechnology-based health products are providing innovative solutions to unmet clinical needs, but standardized methods are needed for quality and safety assessments before clinical translation. This study identifies methodological gaps in the preclinical characterization of nanotechnology-based medicinal products and medical devices, highlighting the need for further research and development in areas such as interaction with complex biological media.
JOURNAL OF CONTROLLED RELEASE
(2021)