{"title":"Quantitative Laser Diffraction Mediated Detection of Submicron and Subvisible Aggregates (100 nm–10 μm) in Biotherapeutics: Need for Regulatory Attention To this Neglected Particle Size Range","authors":"Utkarsh Tathe, Aswani Kancherla, Prajakta Dandekar, Ratnesh Jain","doi":"10.1007/s12247-025-10153-x","DOIUrl":"10.1007/s12247-025-10153-x","url":null,"abstract":"<div><h3>Objective</h3><p>Immunogenicity caused by aggregates in biotherapeutics, particularly peptides and monoclonal antibodies (mAbs), is a significant concern. Aggregates formed during manufacturing and storage may exist in the nanometer (1–100 nm), submicron (100 nm–1 μm), and subvisible (> 1 μm) size ranges, contributing to immunogenicity. Currently, the United States Pharmacopeia (USP) guidelines focus on particles ≥ 10 μm, while there are no specific regulations for monitoring or quantifying submicron and subvisible particles (SMPs and SVP1, 100 nm–10 μm) despite their known immunogenic potential. This study aims to highlight the need for regulatory guidelines by investigating the occurrence of such particles under stress conditions using a quantitative laser diffraction (qLD) technique.</p><h3>Methods</h3><p>The study evaluated the formation of SMPs and SVP1 in four representative biotherapeutic molecules under pH and temperature stress. A relatively newer analytical tool, quantitative laser diffraction (qLD), was employed to detect and quantify these particles. Additionally, case studies, including Peginesatide’s market withdrawal due to hypersensitivity reactions linked to SMPs and SVP1, and research demonstrating higher immunogenicity of submicron particles in mice, were reviewed to support the study’s objectives.</p><h3>Results</h3><p>The qLD analysis revealed a significant tendency for aggregate formation in the SMP and SVP1 size ranges under stress conditions. The findings reinforce existing evidence that these particles contribute to immunogenic reactions and highlight their potential impact on biotherapeutic safety and efficacy.</p><h3>Conclusions</h3><p>This study underscores the critical need for establishing regulatory guidelines for monitoring and quantifying SMPs and SVP1 in biotherapeutic products. Improved monitoring practices will enhance drug safety and efficacy, ultimately protecting patients from adverse immunogenic reactions.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"20 6","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Catalysis LettersPub Date : 2025-10-18DOI: 10.1007/s10562-025-05215-1
Grisel Corro, Fortino Bañuelos, Esmeralda Vidal, Fer Rosales, Ricardo Peña
{"title":"Engineering Ag⁰/Ag⁺ Interfaces via Hydrogen Reduction in ZnO-based Photocatalysts for High-efficiency Solar Phenol Degradation","authors":"Grisel Corro, Fortino Bañuelos, Esmeralda Vidal, Fer Rosales, Ricardo Peña","doi":"10.1007/s10562-025-05215-1","DOIUrl":"10.1007/s10562-025-05215-1","url":null,"abstract":"<div><p>This work reports the synthesis and photocatalytic evaluation of an Ag/ZnO nanocomposite for efficient degradation of phenol under solar irradiation. The photocatalyst was prepared by impregnating ZnO with AgNO₃, followed by reduction in pure hydrogen gas at 450 °C. This process resulted in the simultaneous formation of metallic silver (Ag⁰) and silver oxide (Ag₂O), incorporating both Ag⁰ and Ag¹⁺ species on the ZnO surface. X-ray photoelectron spectroscopy (XPS) confirmed the coexistence of Ag⁰ and Ag₂O at the Ag–ZnO interface, indicating that strong metal–support interactions and Fermi level alignment facilitated partial oxidation of Ag⁰ into Ag⁺, even under reducing conditions. The photocatalytic activity of the composite was significantly enhanced compared to pure ZnO, achieving ~ 98% phenol degradation within 3 h of solar exposure. This improvement is attributed to the synergistic effects of Ag⁰ and Ag₂O: Ag⁰ induces localized surface plasmon resonance (LSPR), while Ag₂O acts as an electron mediator, suppressing charge recombination and extending light absorption into the visible region. These findings highlight the critical role of controlled silver oxidation states, tailored via hydrogen treatment, in designing efficient photocatalysts for solar-driven environmental remediation.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":508,"journal":{"name":"Catalysis Letters","volume":"155 11","pages":""},"PeriodicalIF":2.3,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10562-025-05215-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparing parametric and nonparametric approaches for estimating forage availability using remote sensing and climatic datasets","authors":"Sajad Alimahmoodi Sarab, Farajollah Tarnian, Ebrahim Karimi Sangchini, Mahmood Najafi Zilaie","doi":"10.1007/s10661-025-14679-y","DOIUrl":"10.1007/s10661-025-14679-y","url":null,"abstract":"<div><p>Accurate estimation of forage availability is crucial for effective rangeland management. This study, conducted in a hot semi-arid rangeland (844.7 ha) in Khuzestan province, Iran, outlines a three-step approach to achieve this goal. Forage availability was measured using the cutting and weighing method on 58 one-square-meter sample plots. Initially, remote sensing (Sentinel-2) and climatic indicators were prepared, and the Pearson correlation coefficient was employed to analyze relationships between these independent variables and the dependent variable (forage mass). The second step focused on identifying optimal vegetation indices for forage availability estimation using multiple linear regression (MLR), Random Forest (RF), and classification and regression trees (C&RT) algorithms. The third step aimed to enhance model performance by integrating vegetation and climatic indices. Using 58 sample plots, 30 were used for modeling and 28 exclusively for final validation. A k-fold cross-validation (k = 5) was employed, with 47 plots for training and 11 for validation in each iteration. Model performance (MLR, RF, C&RT) was evaluated using average R<sup>2</sup> and RMSE metrics from all validation folds, ensuring robust and reliable results. The Random Forest used an internal 60–20-20 split. Correlation analysis revealed that MSAVI2 (-0.83), SAVI (-0.23), DVI (-0.17), potential evapotranspiration index (-0.42), and Transou index (0.35) were the most significant variables. In the second step, R<sup>2</sup> values for MLR, RF, and C&RT models were 0.54, 0.54, and 0.68, respectively. Incorporating potential evapotranspiration and Transou indices into the models boosted their coefficients of determination to 0.68, 0.72, and 0.91, with corresponding RMSE reductions of 85%, 69%, and 22%. The study concludes that a combination of the MSAVI2 index with potential evapotranspiration and Transou indices, implemented through the non-parametric C&RT regression, offers a robust method for estimating rangeland forage availability in hot, semi-arid, and arid environments.</p></div>","PeriodicalId":544,"journal":{"name":"Environmental Monitoring and Assessment","volume":"197 11","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"环境科学与生态学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Electroporation-based CRISPR/Cas9 Gene Editing in Haliotis Discus Hannai","authors":"Chen Liu, Dianzhi Yao, Yulu Jiang, Chuncao Huo, Jinhai Zhang, Suyuan Yi, Wenhao Yang, Yijing Han, Yaqiong Liu, Xiaotong Wang","doi":"10.1007/s10126-025-10526-w","DOIUrl":"10.1007/s10126-025-10526-w","url":null,"abstract":"<div><p>Abalone, a marine mollusk with significant economic and ecological value, plays a crucial role in sustainable aquaculture. The development and application of CRISPR-Cas9 gene-editing technology have opened up a new path for improving breeding efficiency. CRISPR/Cas9-mediated gene editing has been achieved in abalones via microinjection. In this study, a gene encoding myostatin MSTN in <i>H. discus hannai</i>; was selected as target for conducting the CRISPR-Cas9 gene editing experiment in combination with an electroporation delivery system. Our results showed that all three sgRNAs effectively targeted and cleaved the target segment, with sgRNA1 and sgRNA2 exhibiting high in vitro activity. After electroporation, the effects of transfection on embryonic development of fertilized eggs were observed and statistically analyzed. 12.7 ± 5.4% of the fertilized eggs were damaged and deformed after electroporation. Twenty-four hours after electroporation, surviving larvae were collected for DNA extraction and sequencing. Two potential mutations within the target region of MSTN were identified by sequencing. These results provide a reference for the improvement and development of CRISPR-mediated gene editing methods in marine mollusks such as abalones.</p></div>","PeriodicalId":690,"journal":{"name":"Marine Biotechnology","volume":"27 6","pages":""},"PeriodicalIF":2.8,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Assessment of environmental impacts associated with production of breakfast cereal using life cycle assessment: approach for sustainable development.","authors":"Yogesh Jadhav, Sampatrao Manjare","doi":"10.1007/s11356-025-37072-1","DOIUrl":"https://doi.org/10.1007/s11356-025-37072-1","url":null,"abstract":"<p><p>This study presents a comprehensive life cycle assessment (LCA) of ready-to-eat breakfast cereal production in India, a rapidly growing food sector with limited environmental assessment. Using the ReCiPe 2016 Midpoint and Endpoint methods, three scenarios were evaluated: conventional production, sustainable agriculture, and renewable energy integration. The results reveal clear environmental hotspots in agricultural production, particularly rice irrigation, fertilizer use, and sugarcane production that drive impacts such as global warming, eutrophication, and human toxicity. The integration of sustainable practices and renewable energy reduced the global warming potential (climate change) by 31%, fine particulate matter formation by 28%, terrestrial acidification by 30%, human carcinogenic toxicity by 25%, fossil resource scarcity by highest 32%, and water consumption by 21%. These findings underscore that combining sustainable farming inputs with renewable energy transitions can meaningfully reduce the environmental burden of cereal production. Beyond quantitative results, the study highlights critical data gaps in pesticide emissions and irrigation flows, providing a methodological framework to strengthen future LCA studies in emerging economies. The outcomes offer practical guidance for industry stakeholders and policymakers seeking to align food production with sustainability goals.</p>","PeriodicalId":545,"journal":{"name":"Environmental Science and Pollution Research","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"环境科学与生态学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hussein S Mohamed, Mahmoud M Swilam, Zeinab S Hamza, Amany R Abdulqawi, Qamit Kumar, Seham M Hamed
{"title":"Harnessing seaweed biomass for sustainable bioethanol production and carbon sequestration: technological advances and future prospects.","authors":"Hussein S Mohamed, Mahmoud M Swilam, Zeinab S Hamza, Amany R Abdulqawi, Qamit Kumar, Seham M Hamed","doi":"10.1007/s11356-025-37071-2","DOIUrl":"https://doi.org/10.1007/s11356-025-37071-2","url":null,"abstract":"<p><p>Seaweeds, prevalent along coastlines globally, offer significant potential for bio-alcohol production and carbon dioxide sequestration due to their rapid, carbon-neutral growth in the coastal waters. This review explores the significant potential of seaweed biomass for bioethanol production and carbon sequestration, emphasizing the need for sustainable practices in seaweed farming and processing. Herein, the scope of this review is defined by focusing on the advancements in seaweed cultivation methods, their biochemical composition, and the challenges of converting seaweed biomass into biofuels. The review critically evaluates various pre-treatment and conversion techniques, such as fermentation and thermochemical processes, and their impact on bioethanol yield. Furthermore, the environmental benefits of seaweed cultivation, particularly its role in CO₂ sequestration and climate change mitigation, are discussed. The economic feasibility of large-scale seaweed-based biofuel production is also assessed, highlighting the need for innovations in cultivation technologies, biomass conversion, and efficient fermentation processes. Knowledge gaps are identified, and future research directions are suggested to optimize biofuel production from seaweed, emphasizing the importance of interdisciplinary collaboration and technological advancements.</p>","PeriodicalId":545,"journal":{"name":"Environmental Science and Pollution Research","volume":" ","pages":""},"PeriodicalIF":5.8,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"环境科学与生态学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correlations in Uniform Spanning Trees: a Fermionic Approach","authors":"Alan Rapoport","doi":"10.1007/s10955-025-03510-0","DOIUrl":"10.1007/s10955-025-03510-0","url":null,"abstract":"<div><p>In the present paper we establish a clear correspondence between probabilities of certain edges belonging to a realization of the <i>uniform spanning tree</i> (UST), and the states of a <i>fermionic Gaussian free field</i>. Namely, we express the probabilities of given edges belonging or not to the UST in terms of fermionic Gaussian expectations. This allows us to explicitly calculate joint probability mass functions of the degree of the UST on a general finite graph, as well as obtain their scaling limits for certain regular lattices.</p></div>","PeriodicalId":667,"journal":{"name":"Journal of Statistical Physics","volume":"192 11","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10955-025-03510-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"物理与天体物理","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ryonosuke Kasai, Haruki Ito, Hitoshi Kiyokawa, Leo Kamiya, Saman Alavi, Ryo Ohmura
{"title":"Phase Equilibria of D2O Hydrates for Hydrate-Based Tritium Separation","authors":"Ryonosuke Kasai, Haruki Ito, Hitoshi Kiyokawa, Leo Kamiya, Saman Alavi, Ryo Ohmura","doi":"10.1007/s10765-025-03666-7","DOIUrl":"10.1007/s10765-025-03666-7","url":null,"abstract":"<div><p>Clathrate-hydrate-based tritium separation from isotope water is a promising process for removing tritium that is not effectively separated by conventional methods. Clathrate hydrates (hereafter hydrates) are crystalline compounds composed of water and guest molecules. Hydrate-based tritium separation utilizes the property that heavy water (D<sub>2</sub>O) forms hydrates under milder temperatures than light water (H<sub>2</sub>O). Efficient industrial operation requires a guest compound that forms hydrates at high temperatures and low pressures and has a large difference in phase equilibrium temperature between H<sub>2</sub>O and D<sub>2</sub>O hydrates (Δ<i>T</i><sub>DH</sub>). In this study, we measured the phase equilibrium conditions of D<sub>2</sub>O hydrates formed with HFC-134a, HFC-32, and HFC-23. The formation of D<sub>2</sub>O hydrates with these guests can be a route to tritium separation through co-precipitation of T<sub>2</sub>O. HFC-134a formed hydrates under the mildest conditions, with Δ<i>T</i><sub>DH</sub> values of 2.8 K, 1.8 K, and 2.4 K for HFC-134a, HFC-32, and HFC-23. In addition to the three investigated guests, the potentials of propane, cyclopentane, and cyclopentane + CO₂ hydrate systems for hydrogen isotope separations were also compared, suggesting that HFC-134a and cyclopentane may be suitable guests for tritium separation. Present and previous studies have also shown a strong positive correlation between the hydration number and Δ<i>T</i><sub>DH</sub> (correlation coefficient = 0.76). This trend may be ascribed to the fact that a higher proportion of water molecules in the hydrate amplifies the effect of replacing H<sub>2</sub>O with D<sub>2</sub>O. These results indicate that the equilibrium conditions of D₂O hydrates may be approximately predicted to identify suitable guests for tritium separation.</p></div>","PeriodicalId":598,"journal":{"name":"International Journal of Thermophysics","volume":"46 12","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Linye Zhu, Wenbin Sun, Shouhang Du, Deqin Fan, Xuesheng Zhao
{"title":"Analysis of the Spatial and Temporal Distribution of Fires and their Atmospheric Changes in the Amazon from 2001 to 2022","authors":"Linye Zhu, Wenbin Sun, Shouhang Du, Deqin Fan, Xuesheng Zhao","doi":"10.1007/s11270-025-08728-y","DOIUrl":"10.1007/s11270-025-08728-y","url":null,"abstract":"<div><p>The Amazon fires have had a profound impact on the region's environment and the Earth's overall ecosystem. However, the full extent of the impact of these fires on their surroundings is not yet fully understood. This study utilizes annual composite and seasonal composite fire data from January 2001 to December 2022, along with CH<sub>4</sub>, HCHO, CO, NO<sub>2</sub>, SO<sub>2</sub>, O<sub>3</sub>, surface temperature, and precipitation data, to investigate the effects of Amazon fires on meteorological conditions and air pollutants during the 2001–2022 period. The study results show that: (1) over the past 22 years, the Amazon has experienced varying degrees of fires, with a decreasing trend in fire area. The largest fire area occurred in 2005, covering about 632,356 km<sup>2</sup>. (2) Fires, pollutants, and precipitation are all seasonal in the Amazon region, as the area of fires is significantly higher in autumn and summer compared to winter and spring. (3) High surface temperatures are concentrated in the northern, eastern, and southern regions. (4) From 2001 to 2022, the fire area in the Amazon was negatively correlated with precipitation and positively correlated with surface temperature. (5) During the period of 2019–2022, fire areas were significantly and positively correlated with HCHO, NO<sub>2</sub>, CH<sub>4</sub>, and CO. There were also correlations between fire area and SO<sub>2</sub> and O<sub>3</sub>. This study has, to a certain extent, explored the impact of fires on the Amazon environment, holding significant implications for the region's sustainable development.</p></div>","PeriodicalId":808,"journal":{"name":"Water, Air, & Soil Pollution","volume":"237 1","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"环境科学与生态学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Integrated numerical model for fault rupture propagation through uniform soil","authors":"Abhiparna Dasgupta, Partha Sarathi Nayek, Maheshreddy Gade","doi":"10.1007/s10064-025-04516-4","DOIUrl":"10.1007/s10064-025-04516-4","url":null,"abstract":"<div><p>This study develops a novel numerical model using Abaqus 2D to examine fault rupture propagation through uniform soil. The model simulates a soil layer overlying elastic bedrock, initiating the fault rupture within the bedrock, ensuring a more realistic representation of rupture propagation. Validated against centrifuge tests and previous numerical studies, the model accurately predicts key engineering parameters such as surface deformation and fault outcrop location. The study highlights significant surface deformation and double shear band formation during normal faulting. Additionally, a parametric study examines the impact of earthquake magnitude and dip-angle on fault outcrop, plastic strain zones, and set-back distances. The proposed model offers greater flexibility in incorporating variations in seismic sources, providing valuable insights into rupture propagation through uniform soil, with implications for seismic hazard assessment and infrastructure resilience.</p></div>","PeriodicalId":500,"journal":{"name":"Bulletin of Engineering Geology and the Environment","volume":"84 11","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145316359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}