Best Practices and Pitfalls in Commercializing IVD-Applicable Biomarkers

Before biomarker discoveries can be commercially utilized in clinical laboratories, many studies and surveys need to be completed and many questions answered. Is there a market need? Is there enough scientific and clinical evidence to convince the end users? Is the biomarker patentable? Is the translation into a practical product feasible? Although commercial product development is not the focus of academic research, the route to reach the patients will almost always require a professional commercialization process. Understanding industry and end-user requirements is essential for the successful commercialization of new biomarker assays. The current handbook collects some of the best practices and pitfalls encountered at different phases of biomarker discovery, development, patent protection and technology transfer at universities, hospitals and research organizations. The focus is on in vitro diagnostics (IVD)-applicable biomarkers, i.e. markers intended to provide information on the health status of a person. The input for the collection has been sought from true-life practices: practices found in literature or taught by experts in the field; opinions and expertise of different stakeholders (end users, companies, technology transfer professionals, researchers, financiers); recommendations, regulation and laws; as well as practices learned the hard way, i.e. repeatedly failing somewhere in the process and later adapting the process for increased success. The main target group of the handbook comprises professionals working in Technology Transfer Offices (TTOs). The presented practices are yet not intended to be interpreted as strict rules but rather as a source of inspiration. Optimal ways to proceed with patenting and commercialization significantly vary between cases and circumstances.The handbook has been prepared within the EU-project Biomarker Commercialization (BIC) comprising 9 partners in the Baltic Sea Region (BSR) united with the same challenges, as well as the common objective of more efficiently bringing new and better IVD-applicable biomarkers from discovery into clinical use. The project's budget is EUR 2.55 million and is co-financed by the European Regional Development Fund through the Interreg Baltic Sea Region Programme with EUR 1.96 million

Paper-based enzymatic microfluidic fuel cell: From a two-stream flow device to a single-stream lateral flow strip

This work presents a first approach towards the development of a cost-effective enzymatic paper-based glucose/O2 microfluidic fuel cell in which fluid transport is based on capillary action. A first fuel cell configuration consists of a Y-shaped paper device with the fuel and the oxidant flowing in parallel over carbon paper electrodes modified with bioelectrocatalytic enzymes. The anode consists of a ferrocenium-based polyethyleneimine polymer linked to glucose oxidase (GOx/Fc-C6-LPEI), while the cathode contains a mixture of laccase, anthracene-modified multiwall carbon nanotubes, and tetrabutylammonium bromide-modified Nafion (MWCNTs/laccase/TBAB-Nafion). Subsequently, the Y-shaped configuration is improved to use a single solution containing both, the anolyte and the catholyte. Thus, the electrolytes pHs of the fuel and the oxidant solutions are adapted to an intermediate pH of 5.5. Finally, the fuel cell is run with this single solution obtaining a maximum open circuit of 0.55 ± 0.04 V and a maximum current and power density of 225 ± 17 μA cm−2 and 24 ± 5 μW cm−2, respectively. Hence, a power source closer to a commercial application (similar to conventional lateral flow test strips) is developed and successfully operated. This system can be used to supply the energy required to power microelectronics demanding low power consumption.F. Javier del Campo acknowledges funding from the Spanish Ministry of Economy through the DADDi2 project (TEC2013-48506-C3). Juan Pablo Esquivel would like to thank the support from Marie Curie International Outgoing Fellowship (APPOCS-328144) within the 7th European Community Framework Programme. Shelley D. Minteer and Fabien Giroud would like to thank the National Science Foundation (CHE-1057597) for funding. Neus Sabaté acknowledges funding from the European H2020 Framework Programme (Grant Agreement 648518 - SUPERCELL - ERC 2014 CoG).Peer reviewe

Cellulose: from biocompatible to bioactive material

International audienceSince the papyri, cellulose has played a significant role in human culture, especially as paper. Nowadays, this ancient product has found new scientific applications in the expanding sector of paper-based technology. Among paper-based devices, paper-based biosensors raise a special interest. The high selectivity of biomolecules for target analytes makes these sensors efficient. Moreover, simple paper-based detection devices do not require hardware or specific technical skill. They are inexpensive, rapid, user-friendly and therefore highly promising for providing resource-limited settings with point-of-care diagnostics. The immobilization of biomolecules onto cellulose is a key step in the development of these sensing devices. Following an overview of cellulose structural features and physicochemical properties, this article reviews current techniques for the immobilization of biomolecules on paper membranes. These procedures are categorized into physical, biological and chemical approaches. There is no universal method for biomolecule immobilization. Thus, for a given paper-based biochip, each strategy can be considered

Frustration on a centered pyrochlore lattice in metal-organic frameworks

Geometric frustration inhibits magnetic systems from ordering, opening a window to unconventional phases of matter. The paradigmatic frustrated lattice in three dimensions to host a spin liquid is the pyrochlore, although there remain few experimental compounds thought to realize such a state. Here, we go beyond the pyrochlore via molecular design in the metal-azolate framework [Mn(II)(ta)2], which realizes a closely related centered pyrochlore lattice of Mn spins with S=5/2. Despite a Curie-Weiss temperature of −21 K indicating the energy scale of magnetic interactions, [Mn(II)(ta)2] orders at only 430 mK, putting it firmly in the category of highly frustrated magnets. Comparing magnetization and specific-heat measurements to numerical results for a minimal Heisenberg model, we predict that this material displays distinct features of a classical spin liquid with a structure factor reflecting Coulomb physics in the presence of charges

BAERLIN2014 -The influence of land surface types on and the horizontal heterogeneity of air pollutant levels in Berlin

Urban air quality and human health are among the key aspects of future urban planning. In order to address pollutants such as ozone and particulate matter, efforts need to be made to quantify and reduce their concentrations. One important aspect in understanding urban air quality is the influence of urban vegetation which may act as both emitter and sink for trace gases and aerosol particles. In this context, the "Berlin Air quality and Ecosystem Research: Local and long-range Impact of anthropogenic and Natural hydrocarbons 2014" (BAERLIN2014) campaign was conducted between 2 June and 29 August in the metropolitan area of Berlin and Brandenburg, Germany. The predominant goals of the campaign were (1) the characterization of urban gaseous and particulate pollution and its attribution to anthropogenic and natural sources in the region of interest, especially considering the connection between biogenic volatile organic compounds and particulates and ozone; (2) the quantification of the impact of urban vegetation on organic trace gas levels and the presence of oxidants such as ozone; and (3) to explain the local heterogeneity of pollutants by defining the distribution of sources and sinks relevant for the interpretation of model simulations. In order to do so, the campaign included stationary measurements at urban background station and mobile observations carried out from bicycle, van and airborne platforms. This paper provides an overview of the mobile measurements (Mobile BAERLIN2014) and general conclusions drawn from the analysis. Bicycle measurements showed micro-scale variations of temperature and particulate matter, displaying a substantial reduction of mean temperatures and particulate levels in the proximity of vegetated areas compared to typical urban residential area (background) measurements. Van measurements extended the area covered by bicycle observations and included continuous measurements of O3, NOx, CO, CO2 and point-wise measurement of volatile organic compounds (VOCs) at representative sites for traffic- and vegetation-affected sites. The quantification displayed notable horizontal heterogeneity of the short-lived gases and particle number concentrations. For example, baseline concentrations of the traffic-related chemical species CO and NO varied on average by up to ±22.2 and ±63.5 %, respectively, on the scale of 100 m around any measurement location. Airborne observations revealed the dominant source of elevated urban particulate number and mass concentrations being local, i.e., not being caused by long-range transport. Surface-based observations related these two parameters predominantly to traffic sources. Vegetated areas lowered the pollutant concentrations substantially with ozone being reduced most by coniferous forests, which is most likely caused by their reactive biogenic VOC emissions. With respect to the overall potential to reduce air pollutant levels, forests were found to result in the largest decrease, followed by parks and facilities for sports and leisure. Surface temperature was generally 0.6–2.1 °C lower in vegetated regions, which in turn will have an impact on tropospheric chemical processes. Based on our findings, effective future mitigation activities to provide a more sustainable and healthier urban environment should focus predominantly on reducing fossil-fuel emissions from traffic as well as on increasing vegetated areas

Future buildings as carbon sinks: Comparative analysis of timber-based building typologies regarding their carbon emissions and storage

The building and construction sector is responsible for a large share of carbon emissions resulting in the need to reduce them to mitigate climate change. Timber construction methods promise to lower emissions combined with biogenic carbon storage in the built environment. While there are several studies comparing the emissions of mineral-based and timber-based buildings, a consistent comparison of different timber-based building assemblies is still missing. This study compares carbon emissions from material production and carbon storage capabilities of four timber-based and two brick and reinforced concrete building assemblies. These assemblies were designed for a residential multi-storey building in Berlin, Germany. To compare and rank the carbon impacts of these assemblies we introduce a carbon storage-to-emission ratio. The calculations were performed using a Carbon Cycle Assessment Model implementation in Python. The results indicate an average reduction in carbon emissions of timber-based building assemblies by 32.6% to “Brick” and 40.4% to “Reinforced Concrete”, respectively. Across the timber-based building assemblies, the carbon emissions range between 85 t and 115 t, leading to an average of 105 t per building. Pronounced differences were observed in carbon storage, with the “Dowel Laminated Timber” building assembly storing more than three times the amount of carbon compared to “Light Weight Timber” assembly. To further reduce emissions from buildings and the construction sector and potentially enhance urban carbon storage, “Glue Laminated Timber” and “Dowel Laminated Timber” building assemblies were identified as the most promising