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.

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).

Plant Colonization by Biocontrol Bacteria and Improved Plant Health: A Review.

The use of biological control agents is one of the best strategies available to combat the plant diseases in an ecofriendly manner. Biocontrol bacteria capable of providing beneficial effect in crop plant growth and health, have been developed for several decades. It highlights the need for a deeper understanding of the colonization mechanisms employed by biocontrol bacteria to enhance their efficacy in plant pathogen control.

Self-reported health status of patients with acute retinal ischemia and stroke related hemianopia.

Background: We aimed to assess impairments on health-related quality of life, and mental health resulting from Retinal artery occlusion (RAO) with monocular visual field loss and posterior circulation ischemic stroke (PCIS) with full or partial hemianopia using patient-reported outcome measures (PROMs).

Methods: In a prospective study, consecutive patients with acute RAO on fundoscopy and PCIS on imaging were recruited during their surveillance on a stroke unit over a period of 15 months. Baseline characteristics were determined from medical records and interviews.

Effects of Dual-Site Anodal Transcranial Direct Current Stimulation on Attention, Decision-Making, and Working Memory during Sports Fatigue in Elite Soccer Athletes.

Background: Sports fatigue in soccer athletes has been shown to decrease neural activity, impairing cognitive function and negatively affecting motor performance. Transcranial direct current stimulation (tDCS) can alter cortical excitability, augment synaptic plasticity, and enhance cognitive function. However, its potential to ameliorate cognitive impairment during sports fatigue remains largely unexplored.

Equine temporomandibular joint diseases: A systematic review.

Background: The temporomandibular joint (TMJ) is a unique joint that enables mandibular movement. Temporomandibular diseases (TMDs) impair joint function, leading to more or less specific clinical signs.

Objectives: To compile and disseminate clinical data and research findings from existing publications on equine TMD.

Characterization of the First Marine Pestivirus, Phocoena Pestivirus (PhoPeV).

The first marine pestivirus, Phocoena pestivirus (PhoPeV), isolated from harbor porpoise, has been recently described. To further characterize this unique pestivirus, its host cell tropism and growth kinetics were determined in different cell lines. In addition, the interaction of PhoPeV with innate immunity in porcine epithelial cells and the role of selected cellular factors involved in the viral entry and RNA replication of PhoPeV were investigated in comparison to closely and distantly related pestiviruses.

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.

The Genes of Nigerian Marek's Disease Virus (MDV) Field Isolates Contain Mutations Common to Both European and US High Virulence Strains.

Background: Marek's disease (MD) is a pathology affecting chickens caused by Marek's disease virus (MDV), an acute transforming alphaherpesvirus of the genus . MD is characterized by paralysis, immune suppression, and the rapid formation of T-cell (primarily CD4+) lymphomas. Over the last 50 years, losses due to MDV infection have been controlled worldwide through vaccination; however, these live-attenuated vaccines are non-sterilizing and potentially contributed to the virulence evolution of MDV field strains.

Posterior Positivity Distribution Analysis of Subclinical Bluetongue in the Eastern and North-Eastern States of India: A Wakeup Call for Outbreak Preparedness.

Bluetongue (BT) is considered endemic in the southern states of India, with sporadic incidences reported from the northern, western and central parts of India. However, the eastern and north-eastern states of India have not experienced active disease so far. In the recent past, an extensive sero-epidemiological investigation was carried out in the eastern and north-eastern Indian states.

[Tc]Technetium and Rhenium Dithiocarbazate Complexes: Chemical Synthesis and Biological Assessment.

Background/objectives: Dithiocarbazates (DTCs) and their metal complexes have been studied regarding their property as anticancer activities. In this work, using S-benzyl-5-hydroxy-3-methyl-5-phenyl-4,5-dihydro-1H-pirazol-1-carbodithionate (Hbdtc), we prepared [ReO(bdtc)(Hbdtc)] and [[Tc]TcO(bdtc)(Hbdtc)] complexes for tumor uptake and animal biodistribution studies.

Methods: Re complex was prepared by a reaction of H2bdtc and (NBu)[ReOCl], the final product was characterized by IR, H NMR, CHN, and MS-ESI.

Scalable Manufacturing Method for Model Protein-Loaded PLGA Nanoparticles: Biocompatibility, Trafficking and Release Properties.

: Drug delivery systems (DDSs) offer efficient treatment solutions to challenging diseases such as central nervous system (CNS) diseases by bypassing biological barriers such as the blood-brain barrier (BBB). Among DDSs, polymeric nanoparticles (NPs), particularly poly(lactic-co-glycolic acid) (PLGA) NPs, hold an outstanding position due to their biocompatible and biodegradable qualities. Despite their potential, the translation of PLGA NPs from laboratory-scale production to clinical applications remains a significant challenge.

Effect of Staggered vs. Simultaneous Co-Administration of Bempedoic Acid on Pharmacokinetics of Pravastatin: Randomized, Cross-Over Clinical Trial in Healthy Volunteers.

: Bempedoic acid (BA) is a novel cholesterol-lowering agent with proven positive effects on cardiovascular endpoints. Because it is an inhibitor of the hepatic transporters OATP1B1 and OATP1B3, two uptake transporters regulating the intrahepatic availability of statins, it increases the systemic exposure of co-administered statins. This interaction could raise the risk of myopathy.

Development of Novel Oral Delivery Systems Using Additive Manufacturing Technologies to Overcome Biopharmaceutical Challenges for Future Targeted Drug Delivery.

The development of targeted drug delivery systems for active pharmaceutical ingredients with narrow absorption windows is crucial for improving their bioavailability. This study proposes a novel 3D-printed expandable drug delivery system designed to precisely administer drugs to the upper small intestine, where absorption is most efficient. The aim was to design, prototype, and evaluate the system's functionality for organ retention and targeted drug release.

T14diLys/DOPE Liposomes: An Innovative Option for siRNA-Based Gene Knockdown?

Background/objectives: Bringing small interfering RNA (siRNA) into the cell cytosol to achieve specific gene silencing is an attractive but also very challenging option for improved therapies. The first step for successful siRNA delivery is the complexation with a permanent cationic or ionizable compound. This protects the negatively charged siRNA and enables transfection through the cell membrane.

Phenolic Compounds and Pharmacological Potential of Extracts for the Treatment of Neurodegenerative Diseases.

The search for neuroprotective compounds in lavender is driven by its traditional use for brain health, with antioxidant activity serving as a key mechanism in reducing oxidative stress and supporting cognitive function. Lavender's potential to protect neurons is based on its calming, anti-stress properties, which increase the brain's resistance to neurodegeneration. Although lavender is not a traditional medicinal plant in Ukraine, it is increasingly recognised for its medicinal properties and is widely cultivated in the country.

Cross-National Survey About Nutrition and Nutrition Communication Among Older Adults Aged 60 Years and Above.

The global population is undergoing a significant demographic shift characterised by an increasing proportion of older individuals. Healthy aging has become a priority for personal well-being and sustainable healthcare systems, with nutrition playing a pivotal role. However, the rise in non-communicable diseases (NCDs), malnutrition, and a shift in eating behaviour underscore the need for tailored, effective nutrition communication strategies.

Impact of the Healthy Lifestyle Community Program (HLCP-3) on Trimethylamine N-Oxide (TMAO) and Risk Profile Parameters Related to Lifestyle Diseases During the Six Months Following an Intervention Study.

Rationale: The dietary components choline, betaine, and L-carnitine are converted by intestinal microbiota into the molecule trimethylamine (TMA). In the human liver, hepatic flavin-containing monooxygenase 3 oxidizes TMA to trimethylamine-N-oxide (TMAO). TMAO is considered a candidate marker for the risk of cardiovascular disease.

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.

Effects of Short-Term Low Energy Availability on Metabolism and Performance-Related Parameters in Physically Active Adults.

Background/objectives: Low energy availability (LEA) can cause impaired reproductive function, bone health issues, and suppressed immune function, and may result in decreased performance and overall health status. The purpose of this study was to investigate adaptions of body composition, blood status, resting metabolic rate, and endurance performance to gain more comprehensive insights into the symptoms of LEA and the adaptive effects in the athlete population (active women (n = 11) and men (n = 11)).

Methods: Three treatments were defined as 45 (EA45, control), 30 (EA30), and 10 (EA10) kcal/kg FFM/day and randomly assigned.

Effect of a Novel Food Rich in Miraculin on the Intestinal Microbiome of Malnourished Patients with Cancer and Dysgeusia.

Background/objectives: Dysgeusia contributes to malnutrition and worsens the quality of life of patients with cancer. Despite the different strategies, there is no effective treatment for patients suffering from taste disorders provided by the pharmaceutical industry. Therefore, we developed a novel strategy for reducing side effects in cancer patients by providing a novel food supplement with the taste-modifying glycoprotein miraculin, which is approved by the European Union, as an adjuvant to medical-nutritional therapy.

Relative Energy Deficiency in Sport-Multidisciplinary Treatment in Clinical Practice.

Background/objectives: The primary aim of this study was to characterize athletes approaching an outpatient interdisciplinary and multidisciplinary consultation structure for athletes with a suspected relative energy deficiency in sport (REDs) cross-sectionally and longitudinally to prove treatment efficacy.

Methods: Data of 58 athletes suspected of REDs were collected at the onset (t) and completion (t) of interdisciplinary and multidisciplinary REDs treatment (clinical practice) between January 2019 and December 2022. The data included extracted information from medical records, anthropometric characteristics, physical performance diagnostics, laboratory values, dietary records, and partially gynecological and psychosomatic diagnostics.

Effects of Additional Flexible and Rigid Structure on BDT-BDD Terpolymer and the Performance of Organic Solar Cells.

In organic solar cells, the aggregation and crystallization of polymers are significant for bulk heterojunction. Blending with acceptor materials, polymer donor materials can adjust their aggregation by the movement of the chain segments. In this paper, the unfused structures based on thiophene and carbazole are respectively designed and introduced into the donor-acceptor copolymer donor materials to investigate the influence of flexible and rigid structures on polymer-aggregation leading photoelectric performance.

Electrochemical Switching of Laser-Induced Graphene/Polymer Composites for Tunable Electronics.

Laser reduction of graphene oxide (GO) is a promising approach for achieving flexible, robust, and electrically conductive graphene/polymer composites. Resulting composite materials show significant technological potential for energy storage, sensing, and bioelectronics. However, in the case of insulating polymers, the properties of electrodes show severely limited performance.