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.

Neurotropic Tick-Borne Flavivirus in Alpine Chamois (), Austria, 2017, Italy, 2023.

The European subtype of tick-borne encephalitis virus (TBEV-Eur; species , family ) was the only tick-borne flavivirus present in central Europe known to cause neurologic disease in humans and several animal species. Here, we report a tick-borne flavivirus isolated from Alpine chamois () with encephalitis and attached ticks, present over a wide area in the Alps. Cases were detected in 2017 in Salzburg, Austria, and 2023 in Lombardy and Piedmont, Italy.

Feline Papillomatosis.

Different types of feline papillomaviruses (PVs) are associated with a variety of skin lesions and neoplasia, such as papillomas and cell carcinomas, but the virus can also be found in healthy skin. In this review, the European Advisory Board on Cat Diseases (ABCD), a scientifically independent board of veterinary experts on feline infectious diseases from 11 European Countries, discusses the current knowledge of feline PV infections. Cats most likely become infected through lesions or abrasions of the skin.

"Radix Saniculae": Phytochemical Characterization and Potential Adulteration of an Austrian Traditional Wound-Healing Agent.

The aerial parts (Herba Saniculae) and the underground parts (Radix Saniculae) of (sanicle) have been used traditionally in Austrian folk medicine to treat wounds. Interestingly, in the Austrian vernacular, "Radix Saniculae" can also refer to the underground parts of . This ambiguity can lead to mistakes in using these two plants and, importantly, adulterations.

Differential Enhancement of Fat-Soluble Vitamin Absorption and Bioefficacy via Micellization in Combination with Selected Plant Extracts In Vitro.

Individuals with special metabolic demands are at risk of deficiencies in fat-soluble vitamins, which can be counteracted via supplementation. Here, we tested the ability of micellization alone or in combination with selected natural plant extracts to increase the intestinal absorption and bioefficacy of fat-soluble vitamins. Micellated and nonmicellated vitamins D3 (cholecalciferol), D2 (ergocalciferol), E (alpha tocopheryl acetate), and K2 (menaquionone-7) were tested in intestinal Caco-2 or buccal TR146 cells in combination with curcuma (), black pepper (), or ginger () plant extracts.

Shifting Focus to Quality: An Innovative Modeling Approach Includes Processing History for Rubber Part Quality Simulation.

An innovative modeling approach for the simulative description of the part quality of rubber materials, including the processing history, is presented in this paper. This modeling approach, the so-called average curing speed (ACS) model, is based on the degree of cure and the average curing speed instead of the conventionally considered temperature approach. Such approach neglects the processing history by calculating only the degree of cure.

Eicosapentaenoic Acid and Docosahexaenoic Acid as an Antimicrobial Agent in Orthopedics-An In Vitro Study About the Race for Surface.

Background: The burden of prosthetic joint infection in combination with antibiotic-resistant bacterial strains is a rising dilemma for patients experiencing total joint replacements. Around 0.8-2% of patients experience prosthetic joint infections, while up to 21% of patients are considered fatal cases after 5 years.

Cold Plasma Activity Against Biofilm Formation of Prosthetic Joint Infection Pathogens.

Periprosthetic joint infections occur in 1-2% of all patients undergoing prosthetic joint surgeries. Although strong efforts have been made to reduce infection rates, conventional therapies like one- or two-stage revisions have failed to lower the infection rates. Cold atmospheric plasma (CAP) has shown promising results in reducing bacterial loads on surfaces.

Is the EnodePro a Valid Tool to Determine the Bar Velocity in the Bench Press and Barbell Back Squat? A Comparative Analysis.

Unlabelled: In recent years, the EnodePro device has been one of the most frequently used velocity sensors to track the bar velocity in resistance training, with the aim of providing load-velocity profiles. However, recent articles highlight a lack of reliability and validity in the estimated maximal strength, which can cause a serious health risk due to the overestimation of the bar velocity. With this study, we aimed to investigate whether imprecision in the measurement could explain the variance in this measurement error.

Reliability of a Low-Cost Inertial Measurement Unit (IMU) to Measure Punch and Kick Velocity.

Striking velocity is a key performance indicator in striking-based combat sports, such as boxing, Karate, and Taekwondo. This study aims to develop a low-cost, accelerometer-based system to measure kick and punch velocities in combat athletes. Utilizing a low-cost mobile phone in conjunction with the PhyPhox app, acceleration data was collected and analyzed using a custom algorithm.

Dental Rehabilitation After Microvascular Reconstruction of Segmental Jaw Defects: A Ten-Year Follow-Up.

: Defects in maxillary and mandibular continuity are common in maxillofacial practice. They can occur after trauma, osteonecrosis, congenital jaw deformities, or surgical resection of benign or malignant tumours. Reconstruction with microvascular bone flaps and subsequent prosthetic rehabilitation is considered the contemporary first line treatment.

Continuous Stitches Versus Simple Interrupted Stitches During Anterior Colporrhaphy: A Randomized Controlled Trial.

The anterior vaginal wall is frequently affected by prolapse, which is frequently treated with anterior colporrhaphy. However, this repair has a high recurrence rate, and no standardized approach exists. Our study aimed to compare two suture techniques concerning postoperative outcomes.

Preoperative Non-Invasive Mapping for Targeted Concomitant Surgical Ablation of Non-Paroxysmal Atrial Fibrillation (PreMap Study).

: The present study introduces our targeted approach for concomitant surgical ablation (CSA) using non-invasive phase mapping (NIPM) and describes its effectiveness regarding freedom from atrial fibrillation (AF). : This retrospective study included cardiac surgical patients undergoing preoperative NIPM for CSA guidance. The primary outcome was freedom from AF six months after surgery.

Three-Dimensional Planning for Vascularized Bone Grafts: Implementation and Surgical Application for Complex Bone Reconstruction in the Hand and Forearm.

Vascularized bone grafts have been successfully established for complex bone defects. The integration of three-dimensional (3D) simulation and printing technology may aid in more precise surgical planning and intraoperative bone shaping. The purpose of the present study was to describe the implementation and surgical application of this innovative technology for bone reconstruction.

Restoration of Genuine Sensation and Proprioception of Individual Fingers Following Transradial Amputation with Targeted Sensory Reinnervation as a Mechanoneural Interface.

: Tactile gnosis derives from the interplay between the hand's tactile input and the memory systems of the brain. It is the prerequisite for complex hand functions. Impaired sensation leads to profound disability.

Comparative Assessment of CMR-Determined Extracellular Volume Metrics in Predicting Adverse Outcomes.

Extracellular volume (ECV) by cardiovascular magnetic resonance (CMR) imaging is associated with disease burden and clinical outcomes. Recent studies in patients with valvular heart disease (VHD) have suggested that the indexed total ECV (iECV) = ECVx(LV/1.05)/body surface area may supersede ECV in terms of prognostication.

Therapeutic Management of Gastroesophageal Reflux Disease (GERD)-Is There Something Between PPI and Fundoplication? An Overview.

Gastroesophageal reflux disease (GERD) affects millions globally, with traditional treatments like proton pump inhibitors (PPIs) and surgical fundoplication presenting challenges such as long-term medication dependency and disturbing long term side effects following surgery. This review explores emerging, alternative therapies that offer less invasive, personalized alternatives for GERD management. Endoscopic approaches, including Stretta therapy, transoral incisionless fundoplication (TIF), and endoscopic full-thickness plication (EFTP), demonstrate promising but also controversial outcomes in symptom relief and reduced acid exposure.

Early Surgery and Screw-Only Osteosyntheses in Minimally Invasive Treatment of Calcaneal Fractures-Risk or Benefit for Our Patients?

This study aims to analyze the outcomes following the minimally invasive surgery of calcaneal fractures using screw-only osteosynthesis, as well as the impact of surgical timing. Between 2015 and 2020, 155 patients with 168 fractures were included. According to the Sanders classification, 48.

Effects of Calcium-Oxide-Modified Biochar on the Anaerobic Digestion of Vacuum Blackwater.

The increasing global population and urbanization have led to significant challenges in waste management, particularly concerning vacuum blackwater (VBW), which is the wastewater generated from vacuum toilets. Traditional treatment methods, such as landfilling and composting, often fall short in terms of efficiency and sustainability. Anaerobic digestion (AD) has emerged as a promising alternative, offering benefits such as biogas production and digestate generation.

Pilot Study on AI Image Analysis for Lower-Limb Reconstruction-Assessing ChatGPT-4's Recommendations in Comparison to Board-Certified Plastic Surgeons and Resident Physicians.

AI, especially ChatGPT, is impacting healthcare through applications in research, patient communication, and training. To our knowledge, this is the first study to examine ChatGPT-4's ability to analyze images of lower leg defects and assesses its understanding of complex case reports in comparison to the performance of board-certified surgeons and residents. We conducted a cross-sectional survey in Switzerland, Germany, and Austria, where 52 participants reviewed images depicting lower leg defects within fictitious patient profiles and selected the optimal reconstruction techniques.

Searching for More Effective Food Baits for Tephritid Fruit Flies (Diptera: Tephritidae): Performance of Newly Developed Vial-Lures Relative to Torula Yeast Borax.

Food-baited traps are an important part of early detection programs for invasive tephritid fruit fly species, as they are attractive to both sexes of all targeted species. Torula yeast borax (TYB) mixture is a standard food bait, but its longevity is limited (1-2 weeks). Synthetic food-based lures have been developed, including ammonium acetate, putrescine, and trimethylamine.

Characterizing SV40-hTERT Immortalized Human Lung Microvascular Endothelial Cells as Model System for Mechanical Stretch-Induced Lung Injury.

Drug development for human disease relies on preclinical model systems such as human cell cultures and animal experiments before therapeutic treatments can ultimately be tested on humans in clinical studies. We here describe the generation of a novel human cell line (HLMVEC/SVTERT289) that we generated by transfection of microvascular endothelial cells from healthy donor lung tissue with the catalytic domain of telomerase and the SV40 large T/small t-antigen. These cells exhibited satisfactory growth characteristics and largely maintained their native characteristics, including morphology, cell surface marker expression, angiogenic potential and the protein composition of secreted extracellular vesicles.

Potential of Trilayered Gelatin/Polycaprolactone Nanofibers for Periodontal Regeneration: An In Vitro Study.

Over the past few years, biomaterial-based periodontal tissue engineering has gained popularity. An ideal biomaterial for treating periodontal defects is expected to stimulate periodontal-derived cells, allowing them to contribute most efficiently to tissue reconstruction. The present study focuses on evaluating the in vitro behavior of human periodontal ligament-derived stromal cells (hPDL-MSCs) when cultured on gelatin/Polycaprolactone prototype (GPP) and volume-stable collagen matrix (VSCM).

The Cell Polarity Protein MPP5/PALS1 Controls the Subcellular Localization of the Oncogenes and in Liver Cancer.

The oncogenes yes-associated protein () and transcriptional coactivator with PDZ-binding motif () are potent liver oncogenes. Because gene mutations cannot fully explain their nuclear enrichment, we aim to understand which mechanisms cause activation in liver cancer cells. The combination of proteomics and functional screening identified numerous apical cell polarity complex proteins interacting with YAP and TAZ.

Probing Spatiotemporal Effects of Intertrack Recombination with a New Implementation of Simultaneous Multiple Tracks in TRAX-CHEM.

Among the most investigated hypotheses for a radiobiological explanation of the mechanism behind the FLASH effect in ultra-high dose rate radiotherapy, intertrack recombination between particle tracks arriving at a close spatiotemporal distance has been suggested. In the present work, we examine these conditions for different beam qualities and energies, defining the limits of both space and time where a non-negligible chemical effect is expected. To this purpose the TRAX-CHEM chemical track structure Monte Carlo code has been extended to handle several particle tracks at the same time, separated by pre-defined spatial and temporal distances.