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Regulation of advanced therapy medicinal products in Europe and the role of academia

Background aims. Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to ensure their free movement within the European Union while guaranteeing the highest level of health protection for patients. Academic good manufacturing practice (GMP) centers are major contributors in the development of ATMPs and th

Active signals, gradient formation and regional specificity in neural induction.

The question of how the vertebrate embryo gives rise to a nervous system is of paramount interest in developmental biology. Neural induction constitutes the earliest step in this process and is tightly connected with development of the embryonic body axes. In the Xenopus embryo, perpendicular gradients of BMP and Wnt signals pattern the dorsoventral and anteroposterior body axes. Both pathways nee

Numerical contribution to segmented chip effect on residual stress distribution in orthogonal cutting of Inconel718

Segmented chip morphology has a significant influence on distribution of residual stress and surface topography on machined surface in machining difficult-to-cut materials. In this paper, Coupled Eulerian and Lagrangian (CEL) model is employed to investigate the effect of segmented chip on surface integrity (residual stress distribution and surface topography) in orthogonal machining of Inconel718

On the interaction of softwood hemicellulose with cellulose surfaces in relation to molecular structure and physicochemical properties of hemicellulose

The substantial part of the water-soluble hemicellulose fraction, obtained when processing cellulose to produce paper and other products, has so far been discarded. The aim of this work is to reveal the interfacial properties of softwood hemicellulose (galactoglucomannan, GGM) in relation to their molecular and solution structure. In this study the sugar composition of GGM was characterised by che

Particle characterization and toxicity in C57BL/6 mice following instillation of five different diesel exhaust particles designed to differ in physicochemical properties

BACKGROUND: Diesel exhaust is carcinogenic and exposure to diesel particles cause health effects. We investigated the toxicity of diesel exhaust particles designed to have varying physicochemical properties in order to attribute health effects to specific particle characteristics. Particles from three fuel types were compared at 13% engine intake O2 concentration: MK1 ultra low sulfur diesel (DEP1

Fano's propensity rule in angle-resolved attosecond interferometry

Above-threshold ionization is a corner stone of attsecond science. In this work we extend Fano's propensity rule to two-photon above-threshold ionization and show that the asymmetry between absorption and emission of the second photon predicted by this propensity rule has strong implications for angle-resolved pump-probe experiments and in particular for attosecond photoelectron interferometry.

Osteopontin and disease activity in patients with recent-onset systemic Lupus Erythematosus : Results from the SLICC Inception Cohort

Objective. In cross-sectional studies, elevated osteopontin (OPN) levels have been proposed to reflect, and/or precede, progressive organ damage and disease severity in systemic lupus erythematosus (SLE). We aimed, in a cohort of patients with recent-onset SLE, to determine whether raised serum OPN levels precede damage and/or are associated with disease activity or certain disease phenotypes. Met

Test administrator effects on cognitive performance in a longitudinal study of ageing

In longitudinal studies, changes in participants’ cognitive performances can partly be attributed to variations in the testing situation (testing specific factors), such as, different test administrators or different testing environments. Focusing on test administrator influence, testing specific factors were examined in a Swedish longitudinal study of ageing. Test scores from 6,686 examinations r

The Swedish Neonatal Quality Register – contents, completeness and validity

Aim: To describe the Swedish Neonatal Quality Register (SNQ) and to determine its completeness and agreement with other registers. Methods: SNQ collects data for infants admitted to neonatal units during the first four postnatal weeks. Completeness and registers’ agreement were determined cross-linking SNQ data with Swedish population registers (the Inpatient, Medical Birth and Cause of Death Regi

Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis–an external quality assessment workshop

Background and Objectives: Fetal RHD genotyping of cell-free fetal DNA from RhD-negative pregnant women can be used to guide targeted antenatal and postnatal anti-D prophylaxis for the prevention of RhD immunization. To assure the quality of clinical testing, we conducted an external quality assessment workshop with the participation of 28 laboratories. Materials and Methods: Aliquots of pooled ma

The Oncogene ECT2 Contributes to a Hyperplastic, Proliferative Lung Epithelial Cell Phenotype in Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) and lung cancer represent progressive lung diseases with a poor prognosis. IPF represents a risk factor for the development of lung cancer, and the incidence of lung cancer is increased in patients with IPF. Disease pathogenesis of IPF and lung cancer involves common genetic alterations, dysregulated pathways, and the emergence of hyperplastic and metaplastic ep

Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus

Objectives Belimumab is the first biologic drug approved for Systemic Lupus Erythematosus (SLE). Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three Swedish real-life settings. Methods Fifty-eight patients were enrolled at initiation of belimumab and followed longitudinally for up to 53 months.

Single and multiple cardiovascular biomarkers in subjects without a previous cardiovascular event

Aims To assess the incremental value of biomarkers, including N-terminal prohormone of brain natriuretic peptide (NT-proBNP), high-sensitivity troponin T (hs-TnT), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), growth differentiation factor 15 (GDF-15), and procollagen type 1 N-terminal propeptide (P1NP), in predicting incident cardiovascular events and mortality among asympto

Internal oxygen transport to below-ground parts: importance for emergent macrophytes

This thesis examines factors regulating growth and distribution of emergent plants with focus on effects of oxygen supply to the roots. Greenhouse experiments revealed that P. australis acclimatizes to specific water depths with phenotypic plasticity. These phenotypic responses act to increase growth at specific water depths but may result in decreased tolerance to changed water depth. Oxygen nee

Transforming graphite to nanoscale diamonds by a femtosecond laser pulse

Formation of cubic diamond from graphite following irradiation by a single, intense, ultra-short laser pulse has been observed. Highly oriented pyrolytic graphite (HOPG) samples were irradiated by a 100 fs pulse with a center wavelength of 800 nm. Following laser exposure, the HOPG samples were studied using Raman spectroscopy of the sample surface. In the laser-irradiated areas, nanoscale cubic d

Transparent and flexible, nanostructured and mediatorless glucose/oxygen enzymatic fuel cells

Here we detail transparent, flexible, nanostructured, membrane-less and mediator-free glucose/oxygen enzymatic fuel cells, which can be reproducibly fabricated with industrial scale throughput. The electrodes were built on a biocompatible flexible polymer, while nanoimprint lithography was used for their nanostructuring. The electrodes were covered with gold, their surfaces were visualised using s