2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

A Comprehensive Weightbearing Computed Tomography Study on Patients With Hallux Valgus: Exploring Multiplanar Deformity Interrelationships.

Background: Hallux valgus (HV) is a complex, multiplanar deformity. In this study, we examined the interrelationships between various components of this deformity using weightbearing computed tomography (WBCT). We hypothesized that the severity of traditional axial plane deformities would correlate with malpositioning of the metatarsosesamoid complex, first-ray coronal rotational deformity, and malalignment of the hindfoot and midfoot.

Modeling BK Virus Infection in Renal Transplant Recipients.

Kidney transplant recipients require a lifelong protocol of immunosuppressive therapy to prevent graft rejection. However, these same medications leave them susceptible to opportunistic infections. One pathogen of particular concern is human polyomavirus 1, also known as BK virus (BKPyV).

Chordoma Spontaneous Regression After COVID-19.

Chordomas are a low-to-intermediate-grade slow-growing subtype of sarcoma, but show propensity to grow and invade locally with recurrence and metastasis in 10-40% of cases. We describe the first case of spontaneous regression of a solid tumor (histologically and immunohistochemically proven chordoma) after COVID-19. A female patient with clival chordoma underwent occipitocervical fixation prior to tumor resection.

Animal Models, Therapeutics, and Vaccine Approaches to Emerging and Re-Emerging Flaviviruses.

Flaviviruses are arthropod-borne viruses primarily transmitted through the mosquito or genus of mosquitos. These viruses are predominantly found in tropical and subtropical regions of the world with their geographical spread predicted to increase as global temperatures continue to rise. These viruses cause a variety of diseases in humans with the most prevalent being caused by dengue, resulting in hemorrhagic fever and associated sequala.

A Finite Element Method for Modeling Diffusion and Drug Release from Nanocellulose/Nanoporous Silicon Composites.

: A previous study investigated the in vitro release of methylene blue (MB), a widely used cationic dye in biomedical applications, from nanocellulose/nanoporous silicon (NC/nPSi) composites under conditions simulating body fluids. The results showed that MB release rates varied significantly with the nPSi concentration in the composite, highlighting its potential for controlled drug delivery. To further analyze the relationship between diffusion dynamics and the MB concentration, this study developed a finite element (FE) method to solve Fick's equations governing the drug delivery system.

Injectable Tumoricidal Neural Stem Cell-Laden Hydrogel for Treatment of Glioblastoma Multiforme-An In Vivo Safety, Persistence, and Efficacy Study.

Background/objectives: Glioblastoma multiforme (GBM) is the most common high-grade primary brain cancer in adults. Despite efforts to advance treatment, GBM remains treatment resistant and inevitably progresses after first-line therapy. Induced neural stem cell (iNSC) therapy is a promising, personalized cell therapy approach that has been explored to circumvent challenges associated with the current GBM treatment.

Adherence and Body Weight with Daily Avocado Consumption Among Latina Women of the Habitual Diet and Avocado Trial (HAT).

The aim of this study was to examine the adherence, changes in weight, and, waist circumference associated with the daily consumption of a culturally preferred food, namely an avocado, among Hispanic/Latina females in the Habitual Diet and Avocado Trial (HAT). HAT was a multisite, randomized controlled trial conducted between 2018 and 2020. Participants in the Avocado-Supplemented Diet Group were provided with and instructed to consume one avocado/day (~2.

Nutrient-Nutrient Interactions Among Broccoli Glucosinolates and Their Implications for Breeding Cruciferous Crops to Enhance Human Health.

Unlabelled: While a balanced diet can fulfill most nutritional needs, optimizing the composition of specific foods like broccoli can amplify their health benefits.

Background/objectives: Broccoli ( L. Italica group) is a widely consumed cruciferous vegetable valued for its gastrointestinal and immune health benefits.

The Relationship Between a Mediterranean Diet and Frailty in Older Adults: NHANES 2007-2017.

Background: Frailty is a geriatric syndrome of significant public health concern that causes vulnerability to physiologic stressors and an increased risk of mortality and hospitalizations. Dietary intake and quality are contributing factors to the development of frailty. The Mediterranean diet is known to be one of the healthiest eating patterns with promising health impacts for prevention.

Sleep Quality, Nutritional Habits, and Physical Activity in Pediatric Cancer Survivors: A Dyadic Analysis Approach.

Background/objectives: Sleep disturbances are prevalent among pediatric cancer survivors (PCSs) and their caregivers, often leading to poorer dietary choices and reduced physical activity. Additionally, the sleep quality and health behaviors of parents and children can affect each other. This study examined bi-directional associations between PCSs and their parents' sleep quality and health-related behaviors.

Effects of Quercetin and Citrulline on Nitric Oxide Metabolites and Antioxidant Biomarkers in Trained Cyclists.

Background: Quercetin (QCT) and citrulline (CIT) have been independently associated with improved antioxidant capacity and nitric oxide (NO) production, potentially enhancing cardiovascular function and exercise performance. This study aimed to evaluate the combined and independent effects of QCT and CIT supplementation on NO metabolites and antioxidant biomarkers in 50 trained cyclists undergoing a 20 km cycling time trial (TT).

Methods: In a randomized, double-blind, placebo-controlled design, forty-two male and eight female trained cyclists were assigned to QCT + CIT, QCT, CIT, or placebo (PL) groups.

Impact of Oseltamivir and Diabetes Development.

: Influenza is a major global health challenge, causing thousands of deaths annually. Antiviral drugs, particularly oseltamivir, a neuraminidase inhibitor, have become essential therapeutic options due to their oral bioavailability and efficacy. Previous studies suggest a potential association between oseltamivir use and the onset of diabetes mellitus.

Species in Dromedary Camels () and Ruminants from Somalia.

Ehrlichioses, caused by species, are tick-borne diseases (TBDs) that affect animals and humans worldwide. This study aimed to investigate the molecular occurrence of spp. in 530 animals (155 Dromedary camels, 199 goats, 131 cattle, and 45 sheep) in the Benadir and Lower Shabelle regions of Somalia.

Protection Conferred by Gallid Alphaherpesvirus 2 Vaccines Against Immunosuppression Induced by Very Virulent Plus (vv+) Marek's Disease Virus Strains in Commercial Meat Type Chickens.

Very virulent plus Marek's disease virus (vv+MDV) induces severe immunosuppression in commercial chickens. In this study, we evaluated how three Gallid alphaherpesvirus 2 (GaHV-2) vaccines (CVI-988, rMd5-BAC∆Meq, and CVI-LTR) protected against two negative outcomes of vv+MDV infection: (1) reduced viability and frequency of immune cells in the spleen and (2) decreased efficacy of the CEO (chicken embryo origin) vaccine against infectious laryngotracheitis challenge. At 25 days post-infection with vv+MDV 686, all vaccines are protected against the reduced viability of splenocytes.

Mixed-Effects Model to Assess the Effect of Disengagements on Speed of an Automated Shuttle with Sensors for Localization, Navigation, and Obstacle Detection.

The focus of this study is to investigate the underexplored operational effects of disengagements on the speed of an automated shuttle, providing novel insights into their disruptive impact on performance metrics. For this purpose, global positioning system data, disengagement records, weather reports, and roadway geometry data from an automated shuttle pilot program, from July to December 2023, at the University of North Carolina in Charlotte, were collected. The automated shuttle uses sensors for localization, navigation, and obstacle detection.

Early Spatio-Temporal and Cognitive Deficits in Alzheimer's Disease.

Mental representation of spatial information relies on egocentric (body-based) and allocentric (environment-based) frames of reference. Research showed that spatial memory deteriorates as Alzheimer's disease (AD) progresses and that allocentric spatial memory is among the earliest impaired areas. Most studies have been conducted in static situations despite the dynamic nature of real-world spatial processing.

Evaluating ChatGPT-4 for the Interpretation of Images from Several Diagnostic Techniques in Gastroenterology.

Several artificial intelligence systems based on large language models (LLMs) have been commercially developed, with recent interest in integrating them for clinical questions. Recent versions now include image analysis capacity, but their performance in gastroenterology remains untested. This study assesses ChatGPT-4's performance in interpreting gastroenterology images.

Early Autonomic Dysfunction in Traumatic Brain Injury: An Article Review on the Impact on Multiple Organ Dysfunction.

Traumatic brain injury (TBI) is a complex condition and a leading cause of injury-related disability and death, with significant impacts on patient outcomes. Extracranial organ involvement plays a critical role in the outcome of patients following TBI. This review aims to provide a comprehensive overview of the pathophysiology, clinical presentation, and challenges in diagnosing patients with autonomic dysfunction after TBI.

From Anatase TiO Nano-Cuboids to Nano-Bipyramids: Influence of Particle Shape on the TiO Photocatalytic Degradation of Emerging Contaminants in Contrasted Water Matrices.

Water pollution, resulting from industrial effluents, agricultural runoff, and pharmaceutical residues, poses serious threats to ecosystems and human health, highlighting the need for innovative approaches to effective remediation, particularly for non-biodegradable emerging pollutants. This research work explores the influence of shape-controlled nanocrystalline titanium dioxide (TiO NC), synthesized by a simple hydrothermal method, on the photodegradation efficiency of three different classes of emerging environmental pollutants: phenol, pesticides (methomyl), and drugs (sodium diclofenac). Experiments were conducted to assess the influence of the water matrix on treatment efficiency by using ultrapure water and stormwater (basic) collected from an urban drainage system as matrices.

Anion-Directed Assembly of a Bimetallic Pd/Ag Nanocluster: Synthesis, Characterization, and HER Activity.

Palladium-doped silver nanoclusters (NCs) have been highlighted for their unique physicochemical properties and potential applications in catalysis, optics, and electronics. Anion-directed synthesis offers a powerful route to control the morphology and properties of these NCs. Herein, we report a novel Pd-doped Ag NC, [Pd(H)Ag(S){SP(OPr)}] (), synthesized through the inclusion of sulfide and hydride anions.

Effect of Preparation Conditions of Fe@SiO Catalyst on Its Structure Using High-Pressure Activity Studies in a 3D-Printed SS Microreactor.

Fischer-Tropsch synthesis (FTS) in a 3D-printed stainless steel (SS) microchannel microreactor was investigated using Fe@SiO catalysts. The catalysts were prepared by two different techniques: one pot (OP) and autoclave (AC). The mesoporous structure of the two catalysts, Fe@SiO (OP) and Fe@SiO (AC), ensured a large contact area between the reactants and the catalyst.

Biomechanical Behaviors of Molars Restored with Endocrowns Composed of Different Materials.

To assess the biomechanical behaviors of endodontically treated molars (ETMs) restored with endocrowns composed of different materials, forty mandibular molars were assigned to five groups (n = 8 each). Untreated molars constituted the control group (group C); the rest of the teeth that underwent root canal therapy were restored with endocrowns composed of polycrystalline ceramics (ST zirconia, UPCERA) in group ZR, lithium disilicate glass ceramics (UP.CAD, UPCERA) in group LD, resin-based nanoceramics (Hyramic, UPCERA) in group NC, and feldspathic ceramics (CEREC Blocs, Sirona) in group FC.

Structure-Function Relationship of the β-Hairpin of HB27 Laccase.

Thermus thermophilus HB27 laccase (Tth-Lac) is a thermostable enzyme that contains a β-hairpin (Ala292-Gln307) covering the substrate entrance. We analyzed the role of this β-hairpin in the enzymatic activity of Tth-Lac through three β-hairpin mutants: two variants without the β-hairpin (C1Tth-Lac and C2Tth-Lac) and one with a partially modified β-hairpin (P1Tth-Lac). Enzymatic activity was assayed with different substrates with and without copper.

Ferroptosis Inducers Erastin and RSL3 Enhance Adriamycin and Topotecan Sensitivity in ABCB1/ABCG2-Expressing Tumor Cells.

Acquired resistance to chemotherapeutic drugs is the primary cause of treatment failure in the clinic. While multiple factors contribute to this resistance, increased expression of ABC transporters-such as P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and multidrug resistance proteins-play significant roles in the development of resistance to various chemotherapeutics. We found that Erastin, a ferroptosis inducer, was significantly cytotoxic to NCI/ADR-RES, a P-gp-expressing human ovarian cancer cell line.