This article is associated with the MDPI "Catalysts" journal, which belongs to a Special Issue "SBA-15 and Catalysis", "The Effect of Temperature and Time of the Hydrothermal Treatment in the SBA-15 Synthesis Process on the Structure and Textural Properties and the Ability to Reduce the Evolution of Tars in Tobacco Smoking" and the authors Juárez-Serrano, N.; Asensio, J.; Martínez-Castellanos, I.; Beltrán, M.I.; and Marcilla A. ; SBA-15 synthetized at different values of time and temperature of the hydrothermal treatment were mixture with tobacco in order to determine the capacity of reduction of toxic and carcirogenic compounds on tobacco smoke. The effect of temperature is not significative but time presents a remarked effect. And a parameter not frequently studied, the aparent density, has been shown the most relevant relation with the results on smoking experimentos. Finally, the effect of reduce the supernatant liquor also has been studied and the results have shown that the material properties remain practically unchanged. ; Authors wish to thank the Spanish Government, project TQ2015-70726-P (MINECO/FEDER) and the Valencian Conselleria d'Educació, Investigació, Cultura I Esport, project PROMETEO/2016/056, and IDIFEDER 2018/009 for financial support.
SBA-15 has been employed as a tobacco additive with the objective of reducing the toxic and carcinogenic components in tobacco smoke. The effect of the synthesis conditions (temperature, time, and stirring rate) on this application was studied in this paper. The SBA-15 was characterized (RDX, N2 adsorption isotherms, SEM and apparent density), mixed with the 3R4F reference tobacco, and smoked under standard conditions. The composition of the gas and condensed fractions also was analyzed. The morphology of the material plays an important role on this application and is highly influenced by the three variables studied. Long fibers show improved efficiency compared to short fibers. The tar reduction effect was improved when increasing the time of synthesis. Nevertheless, a maximum was observed with temperature (40 °C) and stirring rate (700 rpm). The optimal synthesis conditions obtained were 24 h, 40 °C and 700 rpm, yielding reductions as high as 68% for tar, 67% for nicotine, and 31% for CO. The scaling-up process has only been reported in terms of grams but never in a preindustrial scale (around 4 kg), and thus the results of this analysis show a promising material with properties and behavior similar with respect to the sample synthesized at laboratory scale. ; This research received funding from the Spanish Government, project CTQ2015-70726-P (MINECO/FEDER) and the Valencian Conselleria d'Educació, Investigació, Cultura I Esport, project PROMETEO/2016/056, and GV-IDIFEDER 2018/009.
Different SBA-15 (SBA, Santa Barbara Amorphous) materials were synthetized at different temperature and time during of the hydrothermal treatment. The obtained SBA-15 were characterized by N2 adsorption isotherms, scanning electron microscopy (SEM), X-ray diffraction (DRX), and density in order to establish the influence of these variables on their properties. Mixtures of the obtained catalysts with 3R4F tobacco were prepared and smoked under the ISO 3308 conditions. Temperature of the hydrothermal treatment slightly affects the tars that evolved in the smoking process of the corresponding catalyst tobacco mixtures. Contrarily, the time of the hydrothermal treatment has a marked effect on the reductions of toxic compounds in the smoke. Developed porosity has a positive correlation with the observed tar reduction, whereas the apparent density has a negative correlation with the reduction in toxicity. Moreover, the removal of the supernatant liquors during the hydrothermal treatment does not strongly modify the properties of the materials and may represent an interesting simplification of the process. ; The authors wish to thank the Spanish Government, project TQ2015-70726-P (MINECO/FEDER), and the Valencian Conselleria d'Educació, Investigació, Cultura I Esport, Project PROMETEO/2016/056 and IDIFEDER 2018/009 for financial support.
Solution-processed polymer films are used in multiple technological applications. The presence of residual solvent in the film, as a consequence of the preparation method, affects the material properties, so films are typically subjected to post-deposition thermal annealing treatments aiming at its elimination. Monitoring the amount of solvent eliminated as a function of the annealing parameters is important to design a proper treatment to ensure complete solvent elimination, crucial to obtain reproducible and stable material properties and therefore, device performance. Here we demonstrate, for the first time to our knowledge, the use of an organic distributed feedback (DFB) laser to monitor with high precision the amount of solvent extracted from a spin-coated polymer film as a function of the thermal annealing time. The polymer film of interest, polystyrene in the present work, is doped with a small amount of a laser dye as to constitute the active layer of the laser device and deposited over a reusable DFB resonator. It is shown that solvent elimination translates into shifts in the DFB laser wavelength, as a consequence of changes in film thickness and refractive index. The proposed method is expected to be applicable to other types of annealing treatments, polymer-solvent combinations or film deposition methods, thus constituting a valuable tool to accurately control the quality and reproducibility of solution-processed polymer thin films. ; The work was supported by the Spanish Government (MINECO) and the European Community (FEDER) through grant No. MAT-2011-28167-C02-01. M.M.-V. has been partly supported by a MINECO FPI fellowship (No. BES-2009-020747).
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
In: Lener , T , Gimona , M , Aigner , L , Boerger , V , Buzas , E , Camussi , G , Chaput , N , Chatterjee , D , Court , F A , del Portillo , H A , O'Driscoll , L , Fais , S , Falcon-Perez , J M , Felderhoff-Mueser , U , Fraile , L , Gho , Y S , Goergens , A , Gupta , R C , Hendrix , A , Hermann , D M , Hill , A F , Hochberg , F , Horn , P A , de Kleijn , D , Kordelas , L , Kramer , B W , Kraemer-Albers , E-M , Laner-Plamberger , S , Laitinen , S , Leonardi , T , Lorenowicz , M J , Lim , S K , Lotvall , J , Maguire , C A , Marcilla , A , Nazarenko , I , Ochiya , T , Patel , T , Pedersen , S , Pocsfalvi , G , Pluchino , S , Quesenberry , P , Reischl , I G , Rivera , F J , Sanzenbacher , R , Schallmoser , K , Slaper-Cortenbach , I , Strunk , D , Tonn , T , Vader , P , van Balkom , B W M , Wauben , M , El Andaloussi , S , Thery , C , Rohde , E & Giebel , B 2015 , ' Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper ' , Journal of Extracellular Vesicles , vol. 4 , 30087 . https://doi.org/10.3402/jev.v4.30087
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
xtracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed. ; The authors have not received any funding or benefits from industry to conduct this study. The authors acknowledge the european COST action for supporting the European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD, BM1202, www.cost.eu/COST_Actions/BMBS/ Actions/BM1202) who funded publication of this work.
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addressed.