2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th 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 18th 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.

SERT-Deficient Mice Fed Western Diet Reveal Altered Metabolic and Pro-Inflammatory Responses of the Liver: A Link to Abnormal Behaviors.

Background: The inheritance of the short allele, encoding the serotonin transporter (SERT) in humans, increases susceptibility to neuropsychiatric and metabolic disorders, with aging and female sex further exacerbating these conditions. Both central and peripheral mechanisms of the compromised serotonin (5-HT) system play crucial roles in this context. Previous studies on SERT-deficient (Sert) mice, which model human SERT deficiency, have demonstrated emotional and metabolic disturbances, exacerbated by exposure to a high-fat Western diet (WD).

The Role of Sulfatides in Liver Health and Disease.

Sulfatides or 3-O-sulfogalactosylceramide are negatively charged sulfated glycosphingolipids abundant in the brain and kidneys and play crucial roles in nerve impulse conduction and urinary pH regulation. Sulfatides are present in the liver, specifically in the biliary tract. Sulfatides are self-lipid antigens presented by cholangiocytes to activate cluster of differentiation 1d (CD1d)-restricted type II natural killer T (NKT) cells.

Self-regulation in eHealth: definition, contributing factors, and experiences from blended rehabilitation care.

Purpose: eHealth might contribute to changes in roles and responsibilities of patients and healthcare professionals (HCPs), including the patient's potential to enhance self-regulation. The aim of this study was to identify important aspects and experiences of self-regulation and factors that may support self-regulation in blended rehabilitation care.

Materials And Methods: Semi-structured interviews were conducted among HCPs and patients regarding perceptions and experiences with self-regulation in relation to a telerehabilitation portal.

A genomic variation map provides insights into potato evolution and key agronomic traits.

Hybrid potato breeding based on diploid inbred lines is transforming the way of genetic improvement of this staple food crop, which requires a deep understanding of potato domestication and differentiation. Here, we resequenced 314 diploid wild and landrace accessions to generate a variome map of 47,203,407 variants. Using the variome map, we discovered the reshaping of tuber transcriptome during potato domestication, characterized genome-wide differentiation between landrace groups Stenotomum and Phureja, and identified a jasmonic acid biosynthetic gene possibly affecting tuber dormancy period.

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.

Highly Pathogenic Avian Influenza Contributes to the Population Decline of the Peregrine Falcon () in The Netherlands.

Highly pathogenic avian influenza (HPAI) epizootics have caused repeated mass mortality events among wild birds. The effect of the infection is potentially detrimental for a variety of bird species, including the Peregrine Falcon (). The numbers of wintering and breeding Peregrine Falcons in the Netherlands have recently declined.

Monitoring M-Protein, Therapeutic Antibodies, and Polyclonal Antibodies in a Multiparametric Mass Spectrometry Assay Provides Insight into Therapy Response Kinetics in Patients with Multiple Myeloma.

Multiple Myeloma (MM) is a hematologic malignancy caused by clonally expanded plasma cells that produce a monoclonal immunoglobulin (M-protein), a personalized biomarker. Recently, we developed an ultra-sensitive mass spectrometry method to quantify minimal residual disease (MS-MRD) by targeting unique M-protein peptides. Therapeutic antibodies (t-Abs), key in MM treatment, often lead to deep and long-lasting responses.

Nanoparticle-in-Hydrogel Delivery System for the Sequential Release of Two Drugs.

Background/objectives: Glioblastoma is the most common and lethal primary brain tumor. Patients often suffer from tumor- and treatment induced vasogenic edema, with devastating neurological consequences. Intracranial edema is effectively treated with dexamethasone.

What Is the Optimal Geometry of Dissolving Microneedle Arrays? A Literature Review.

The application of dissolving microneedle arrays (DMNAs) is an emerging trend in drug and vaccine delivery as an alternative for hypodermic needles or other less convenient drug administration methods. The major benefits include, amongst others, that no trained healthcare personnel is required and that the recipient experiences hardly any pain during administration. However, for a successful drug or vaccine delivery from the DMNA, the microneedles should be inserted intact into the skin.

Development of an Adaptable Qualification Test Set for Personnel Involved in Visual Inspection Procedures of Parenteral Drug Products Manufactured Under Good Manufacturing Practice Conditions in Hospital Pharmacy Compounding Facilities.

Parenteral drug products manufactured under GMP conditions should be visually inspected for defects and particulate contamination by trained and qualified personnel. Although personnel qualification is required, no practical protocols or formal guidelines are available for the development of qualification test sets (QTSs) used for qualification procedures. The current practice is to either procure a standardized QTS from a commercial supplier or amass sufficient manufacturing rejects during visual inspection procedures to compile in-house QTSs.

Production of Hydrophobic Microparticles at Safe-To-Inject Sizes for Intravascular Administration.

Hydrophobic microparticles are one of the most versatile structures in drug delivery and tissue engineering. These constructs offer a protective environment for hydrophobic or water-sensitive compounds (e.g.

GWAS Identifies SNP Markers and Candidate Genes for Off-Flavours and Protein Content in Faba Bean ( L.).

Faba bean ( L.) is a valuable ingredient in plant-based foods such as meat and dairy analogues. However, its typical taste and aroma are considered off-flavours in these food applications, representing a bottleneck during processing.

Exploring Nutrient-Adequate Sustainable Diet Scenarios That Are Plant-Based but Animal-Optimized.

: Transitions toward more sustainable food systems may become rather polarized, particularly in the plant-based vs. animal-based debate. These discussions, however, are often based on environmental impact data from individual products or product groups and do not consider that the products together should form a nutrient-adequate diet that is also affordable.

Trajectories of Nutritional Quality, Diet-Related Environmental Impact, and Diet Cost in China: How Much Does Ultra-Processed Food and Drink Consumption Matter?

Background: Rapid socio-economic developments confront China with a rising consumption of ultra-processed foods (UPFs) and ultra-processed drinks (UPDs). This study aims to evaluate their potential impact on diet transformation towards sustainability including nutrition, environmental sustainability, and diet-related cost.

Methods: Dietary intake was assessed by 24 h recalls in 27,311 participants (age: 40.

Profiles of 71 Human Milk Oligosaccharides and Novel Sub-Clusters of Type I Milk: Results from the Ulm SPATZ Health Study.

Background/objectives: Although approximately 160 human milk oligosaccharides (HMOs) have been identified, current studies on HMO quantitation are limited to the 10-19 most abundant HMOs. We assessed the variations in the relative concentrations of 71 HMO structures over lactation in human milk samples by an advanced liquid chromatography-mass spectrometry approach.

Methods: Samples were collected from 64 mothers at 6 weeks, 6 months, and 12 months of lactation in the Ulm SPATZ Health Study, a German birth cohort.

Relative Validity of the Groningen IBD Nutritional Questionnaire (GINQ-FFQ): A Food Frequency Questionnaire Designed to Assess Nutritional Intake in Patients with Inflammatory Bowel Disease.

To assess nutritional intake of patients with inflammatory bowel disease (IBD), a disease-specific food frequency questionnaire (FFQ) was developed: the Groningen IBD Nutritional Questionnaire (GINQ-FFQ). Aim of this study was to assess the relative validity of the GINQ-FFQ. Between 2019 and 2022, participants of the 1000IBD cohort were included and filled out a 3-day food diary and the GINQ-FFQ.

Sleep Posture Detection via Embedded Machine Learning on a Reduced Set of Pressure Sensors.

Sleep posture is a key factor in assessing sleep quality, especially for individuals with Obstructive Sleep Apnea (OSA), where the sleeping position directly affects breathing patterns: the side position alleviates symptoms, while the supine position exacerbates them. Accurate detection of sleep posture is essential in assessing and improving sleep quality. Automatic sleep posture detection systems, both wearable and non-wearable, have been developed to assess sleep quality.

Integrated Spectral Sensitivity as Physics-Based Figure of Merit for Spectral Transducers in Optical Sensing.

The design of optical sensors aims at providing, among other things, the highest precision in the determination of the target measurand. Many sensor systems rely on a spectral transducer to map changes in the measurand into spectral shifts of a resonance peak in the reflection or transmission spectrum, which is measured by a readout device (e.g.

Nighttime Cough Characteristics in Chronic Obstructive Pulmonary Disease Patients.

Coughing is a symptom of many respiratory diseases. An increased amount of coughs may signal an (upcoming) health issue, while a decreasing amount of coughs may indicate an improved health status. The presence of a cough can be identified by a cough classifier.

Image-Based Detection and Classification of Malaria Parasites and Leukocytes with Quality Assessment of Romanowsky-Stained Blood Smears.

Malaria remains a global health concern, with 249 million cases and 608,000 deaths being reported by the WHO in 2022. Traditional diagnostic methods often struggle with inconsistent stain quality, lighting variations, and limited resources in endemic regions, making manual detection time-intensive and error-prone. This study introduces an automated system for analyzing Romanowsky-stained thick blood smears, focusing on image quality evaluation, leukocyte detection, and malaria parasite classification.

Passive Monitoring of Parkinson Tremor in Daily Life: A Prototypical Network Approach.

Objective and continuous monitoring of Parkinson's disease (PD) tremor in free-living conditions could benefit both individual patient care and clinical trials, by overcoming the snapshot nature of clinical assessments. To enable robust detection of tremor in the context of limited amounts of labeled training data, we propose to use prototypical networks, which can embed domain expertise about the heterogeneous tremor and non-tremor sub-classes. We evaluated our approach using data from the Parkinson@Home Validation study, including 8 PD patients with tremor, 16 PD patients without tremor, and 24 age-matched controls.

Reusable Biosensor for Easy RNA Detection from Unfiltered Saliva.

Biosensors are transforming point-of-care diagnostics by simplifying the detection process and enabling rapid, accurate testing. This study introduces a novel, reusable biosensor designed for direct viral RNA detection from unfiltered saliva, targeting SARS-CoV-2. Unlike conventional methods requiring filtration, our biosensor leverages a unique electrode design that prevents interference from saliva debris, allowing precise measurements.

Structural Fatigue Life Monitoring with Piezoelectric-Based Sensors: Fundamentals, Current Advances, and Future Directions.

Structural fatigue can lead to catastrophic failures in various engineering applications and must be properly monitored and effectively managed. This paper provides a state-of-the-art review of recent developments in structural fatigue monitoring using piezoelectric-based sensors. Compared to alternative sensing technologies, piezoelectric sensors offer distinct advantages, including compact size, lightweight design, low cost, flexible formats, and high sensitivity to dynamic loads.