Journals
2026 EN
Denny Kurtis · Znidarsic Maria · Hamedi Hossein
+2 more
ABSTRACT Process analytical technology (PAT), such as Raman spectroscopy, has been used in a wide range of applications across many unit operations in mAb‐producing processes. In continuous manufacturing (CM) processes, PAT can ensure consistent quality throughout operations by continuously monitoring critical attributes. PAT is especially useful when it can replace offline measurements of critical parameters with real‐time, in‐line measurements. In this study, a 785 nm Raman‐based model was developed as an online measurement for the detergent concentration in a continuous viral inactivation (VI) step. In the VI step, detergent is continuously added to a concentrated bioreactor perfusate stream. The Raman flow cell was first calibrated using a bank of previously generated perfusate samples spiked to varying detergent levels to generate a PLS model with an estimated accuracy of 0.02% w/v. Later, the flow cell was directly integrated into a pilot‐scale process to demonstrate real‐time monitoring of the detergent addition step. The development of this Raman‐based detergent measurement will help replace the need for offline analysis by generating nearly instantaneous concentration measurements. This real‐time measurement will be used during processing to ensure the continuous VI step maintains a sufficient level of detergent to effectively inactivate viruses.
Journals
2026 EN
Smesnik Georg · Virgolini Nikolaus · Toth Maria
+2 more
ABSTRACT Human embryonic kidney cells HEK293 are widely used in biopharmaceutical manufacturing, with a recent surge particularly in recombinant adeno‐associated virus production. Despite their industrial relevance, comprehensive data on their genomic background and stability remains limited. Here, we systematically analyze the genetic landscape of various HEK293 cell lines in response to cultivation conditions, clonal selection, genetic manipulation and over time in culture. Adherent HEK293 were adapted to suspension growth using different serum‐free media. Whole genome sequences from these cell lines were analyzed together with previously published data from additional variants in common use. All data sets were aligned against the human reference genome, enabling the assessment of genome stability by evaluation of variants and revealing a conserved genetic core across all lines, regardless of cultivation history or phenotypic divergence. Evaluation of the functional implications of conserved core mutations identified an enrichment in genes related to cellular structure, morphology and cellular connectivity. The distribution of structural variants and single nucleotide polymorphisms indicated a gradual accumulation of mutations over time in culture rather than abrupt shifts in response to environmental changes. Notably, the integrated adenoviral genes remained highly conserved with respect to copy number, integration site and sequence integrity. These findings provide insight into the genomic evolution of HEK293 cells and offer a foundation for further multi‐omics studies aimed at optimizing HEK293 cells for applications in biopharmaceutical production.
Journals
2026 EN
Farias Fernanda Fernandes · Bárbara Maria Cristina Santa · AndreoFilho Newton
+4 more
ABSTRACT IR3535 is a synthetic active ingredient widely recognized for its efficacy in topical insect repellent formulations. Among commonly used repellent actives, it is distinguished by its favorable toxicological profile, making it suitable for use in children from 6 months of age. Ensuring the quality of insect repellents is a critical regulatory practice that directly contributes to public health protection. This study presents the development and validation of a novel, rapid 2.8‐min retention time, and robust high‐performance liquid chromatography method with diode array detection (HPLC‐DAD) for the quantification of IR3535 followed by its application to the analysis of six commercial topical formulations. The method was validated in accordance with ICH Q2(R2) guidelines, demonstrating excellent linearity ( R 2 = 0.996), precision (RSD < 2%), recovery range (98.2%–101.4%), selectivity, low limits of quantification (0.01 mg/mL) and detection (0.003 mg/mL), as well as robustness. This analytical tool enables reliable monitoring of IR3535 content, ensuring product safety, efficacy, and ANVISA compliance. Only 2 out of 6 commercial products analyzed met specifications for IR3535 content. These findings underscore the importance of implementing rigorous quality control practices to ensure regulatory adherence and to protect consumer health and rights.
Journals
2026 EN
Silva Filipa Alves da · Avelar Rita · Peixoto Bernardo
+4 more
ABSTRACT Purpose Depression affects around 280 million people worldwide, and about 30% of patients have treatment‐resistant depression. Ketamine has significant scientific evidence supporting its use as an antidepressant, making it a promising approach for treatment‐resistant cases. Combining ketamine with psychotherapy may enhance therapeutic response and support longer‐lasting cognitive and behavioral change. This pilot proof‐of‐concept study aims to evaluate the effect of treatment with ketamine infusion combined with psychological intervention in a sample of nine patients with treatment‐resistant depression at a general hospital within the Portuguese National Health Service. Methods Clinical outcomes were measured through the clinical interview and the patient health questionnaire (PHQ‐9) to assess complete or partial improvement. Results Following eight weeks of treatment, all showed a reduction in their PHQ‐9 scores, with the median score transitioning from a baseline categorization of “severe” depression to a “moderate” level. It was found that 44.4% (4/9) of participants showed a response to treatment (≥ 50% reduction in the PHQ‐9 score). Among the patients with suicidal ideation, slightly over half showed remission of these thoughts at the end of treatment. Among the participants subsequently monitored as outpatients, only 29% (2/7) experienced a deterioration in mood within three months post‐treatment, requiring an adjustment of antidepressant therapy. Conclusion In our study, an improvement in depressive symptoms was observed, despite their severity, in a sample submitted to multiple previous pharmacological strategies.This retrospective study evaluated ketamine infusions combined with psychotherapy in nine patients with treatment‐resistant depression at a general hospital. After eight weeks, all participants improved, with PHQ‐9 scores shifting from severe to moderate. Overall, 44% responded to treatment, and among those with suicidal ideation, more than half showed remission.
Journals
2026 EN
Ribatti Raffaella Maria · Lanciano Tiziana · Curci Antonietta
ABSTRACT Introduction: The COVID‐19 pandemic has heightened concerns about malingering, particularly given its recognition as an occupational disease in several regions. This study evaluated the applicability of the Verifiability Approach (VA), a credibility assessment tool based on the principle that liars provide fewer verifiable details than truth tellers, to distinguish between honest reporters and malingerers of COVID‐19 infection. Methods A total of 410 participants (51.5% female) completed an online survey via Google Forms. Participants who reported previous COVID‐19 infection ( n = 205) were assigned to either an informed honest ( n = 104) or not‐informed honest ( n = 101) group, while those without prior infection ( n = 205) were assigned to informed malingerers ( n = 105) or not‐informed malingerers ( n = 100) conditions. Participants in the informed condition were briefed about the VA before writing their reports. Results: Informed honest participants provided significantly more verifiable details than both uninformed honest participants and malingerers. The number of verifiable details and the ratio of verifiable details to total details were strongly associated with honesty when participants were informed about the VA, indicating that the information Protocol enhanced diagnostic accuracy. Perceived success was higher among honest participants, particularly those informed about the VA. No significant effects emerged for reported long COVID or fabricated symptoms, likely due to limited variability and low symptom familiarity. Conclusion: The findings support the VA's validity in distinguishing genuine from feigned symptom reports in health‐related contexts. However, the fully online design, lack of factual verification, and potential for misreporting represent key limitations. Future studies should replicate these results in face‐to‐face or ecologically valid settings and extend the VA framework to the study of symptom dissimulation.
Journals
2026 EN
Tavares Maria Castro · Pereira Miguel Alves · Carvalho Ana Isabel
ABSTRACT Sustainable practices are essential for the long‐term viability of healthcare systems worldwide, making the study of healthcare supply chains crucial. This research evaluates the efficiency of sustainable healthcare supply chain management across United Nations (UN) Member States by integrating Sustainable Development Goal indicators with network Data Envelopment Analysis (DEA). This methodological approach enables a detailed evaluation of efficiency by decomposing supply chains into interconnected stages, capturing the multidimensional nature of sustainability. Unlike traditional DEA models, network DEA accounts for internal interactions within supply chains, offering precise insights into inefficiencies at specific stages. The study reveals significant variability in supply chain efficiency, independent of human development levels, indicating that lower development indices do not preclude high efficiency when effective policies are implemented. Using data from the UN database, this analysis encompasses economic, environmental and social dimensions, challenging assumptions of a direct correlation between higher human development levels and supply chain efficiency. The findings highlight the importance of context‐specific strategies and provide novel insights into the drivers of efficiency, offering a robust framework for targeted improvements in global healthcare supply chains. The unexpected outperformance of some lower‐developed countries underscores the universal potential to achieve more sustainable and efficient healthcare supply chains.
Journals
2026 EN
Moussa Tantawy · Krasnikova Natalia · Postoyeva Maria
+2 more
ABSTRACT This study examines how sustainability performance affects the cost of debt financing in the hospitality and tourism industry and whether institutional environment quality moderates this relationship. Using a dataset of 2302 firm‐year observations from 34 countries between 2010 and 2022, the results show that sustainability performance is negatively associated with the cost of debt financing, indicating that sustainability initiatives reduce lender‐perceived risk. Notably, institutional environment quality strengthens this relationship, as countries with stronger governance frameworks and regulatory enforcement enable lenders to reward sustainability commitments more effectively. However, the association weakened during the COVID‐19 pandemic, highlighting how systemic uncertainty altered lender risk perceptions and curtailed the financial benefits of sustainability practices. The findings remain robust across alternative measures, different model specifications, and controls for endogeneity. The findings provide new cross‐country evidence on how firm‐level sustainability initiatives interact with institutional contexts to shape debt financing costs in the hospitality and tourism industry. This study extends neo‐institutional and stakeholder theories by demonstrating how sustainability practices and national governance jointly influence the cost of debt. It also offers critical insights for managers, lenders, and policymakers seeking to align sustainability strategies with financial resilience.
Journals
2026 EN
Raimondi Rodolfo · Schwizer Paola Gina Maria · Cosma Simona
+1 more
ABSTRACT Climate change is reshaping financial stability, making climate risk a critical component of banks' risk management. However, the absence of standardized frameworks validated by central authorities hinders banks' ability to integrate climate risk into existing credit risk models. This study employs a bibliometric and systematic literature review approach to examine the existing white and grey literature regarding the impact of climate change on credit risk components, like probability of default (PD), loss given default (LGD), exposure at default (EAD), and unexpected loss (UL). We highlight that innovations in climate‐adjusted credit risk estimation primarily stem from grey literature but lack empirical validation in academic research. This study encourages academics to refine climate‐adjusted risk metrics, financial institutions to evaluate their applicability, and policymakers to establish a more coherent regulatory approach. It also offers clarification to bank managers and practitioners on which methodologies are most applicable. Our study explains theoretically how climate risks affect creditworthiness and contributes to the development of standardized methodologies for their consistent integration into risk assessments.
Journals
2026 EN
Demartini Maria Chiara · Trucco Sara · Beretta Valentina
ABSTRACT Sustainability disclosure is a topic of growing interest worldwide, especially after the adoption of the Directive 2014/95/EU (NFRD), which mandates specific classes of companies in the European Union to disclose a series of information regarding ESG issues. Moreover, due to the Corporate Sustainability Reporting Directive, new mandatory EU sustainability reporting standards are required. To our best knowledge, only few studies analyzed the content and the quality of nonfinancial disclosure (NFD) after the NFRD in the Italian context, which represents a relevant share of the EU gross domestic product. The purpose of this paper is to examine how the tone of NFD is associated with firms' nonfinancial performance in mandatory settings. All reports by Italian listed firms disclosing information of years 2017–2023 are analyzed. Content analysis is used to assess the quantity and the quality of NFD, whereas a regression analysis tests the link between the tone of NFD and firms' nonfinancial performance. This paper contributes to the current literature on NFD by analyzing the state of the art of the mandatory NFD in one European country and by verifying the link between the tone of NFD and the firms' nonfinancial performance, after the adoption of the NFRD.
Journals
2026 EN
Sica Giusy · Spiniello Chiara · Micozzi Alessandra
+1 more
ABSTRACT This study offers a comprehensive bibliometric and text‐mining overview of two decades of sustainability‐oriented entrepreneurship research. Drawing on 7563 peer‐reviewed articles from the Web of Science Core Collection, we map the field's evolution, thematic structure, and disciplinary convergence, identifying influential authors, networks, and journals. Using rule‐based classification and unsupervised learning, we categorize contributions within a four‐pillar framework encompassing environmental, social, economic, and cultural dimensions and examine their prevalence, overlap, and temporal trends. The results reveal a pronounced shift toward transdisciplinarity: 77% of articles engage with at least three pillars, and 34.5% address all four simultaneously. Building directly on this empirical evidence, we propose the Four‐Pillar Intersectionality Framework (F‐PIF), which reconceptualizes sustainable entrepreneurship as a transdisciplinary knowledge domain shaped by interdependent sustainability logics. The F‐PIF is therefore both derived from and supported by the bibliometric findings, providing an empirically grounded conceptual model that advances theoretical understanding and offers practical guidance for scholars and practitioners navigating entrepreneurship in the age of sustainability.