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https://www.readbyqxmd.com/read/28812871/high-performance-porous-molybdenum-oxynitride-based-fiber-supercapacitors
#1
Dan Ruan, Rui Lin, Kui Jiang, Xiang Yu, Yaofeng Zhu, Yaqin Fu, Zilong Wang, He Yan, Wenjie Mai
Scalable manufacturing of flexible, fiber-shaped energy storage devices has enabled great technological advances in wearable and portable technology. Replacing inefficient oxides with inexpensive and high-performance oxynitrides with more favourable 3D structures is critical if the practical applications of these technologies are to be realised. Here we developed a facile and controllable approach for the synthesis of 3D porous micropillars of molybdenum oxynitride, which exhibit high conductivity, robust stability and excellent energy storage properties...
August 16, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28807013/microneedle-physical-contact-as-a-therapeutic-for-abnormal-scars
#2
David C Yeo, Elizabeth R Balmayor, Jan-Thorsten Schantz, Chenjie Xu
BACKGROUND: Abnormal (keloid and hypertrophic) scars are a significant affliction with no satisfactory single modality therapy to-date. Available options are often ineffective, painful, potentially hazardous, and require healthcare personnel involvement. Herein a self-administered microneedle device based on drug-free physical contact for inhibiting abnormal scars is reported. Its therapeutic activity through microneedle contact eliminates hazards associated with toxic anti-scarring drugs while self-treatment enables administration flexibility...
August 14, 2017: European Journal of Medical Research
https://www.readbyqxmd.com/read/28797612/decentralized-manufacturing-of-cell-and-gene-therapies-overcoming-challenges-and-identifying-opportunities
#3
REVIEW
Richard P Harrison, Steven Ruck, Nicholas Medcalf, Qasim A Rafiq
Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions...
August 7, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28797469/multivariate-statistical-process-control-in-product-quality-review-assessment%C3%A2-%C3%A2-a-case-study
#4
M Kharbach, Y Cherrah, Y Vander Heyden, A Bouklouze
According to the Food and Drug Administration and the European Good Manufacturing Practices (GMP) guidelines, Annual Product Review (APR) is a mandatory requirement in GMP. It consists of evaluating a large collection of qualitative or quantitative data in order to verify the consistency of an existing process. According to the Code of Federal Regulation Part 11 (21 CFR 211.180), all finished products should be reviewed annually for the quality standards to determine the need of any change in specification or manufacturing of drug products...
August 7, 2017: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/28771040/validation-of-thermal-lethality-against-salmonella-enterica-in-poultry-offal-during-rendering
#5
Amie-Marie Jones-Ibarra, Gary R Acuff, Christine Z Alvarado, T Matthew Taylor
Recent outbreaks of human disease following contact with companion animal foods cross-contaminated with enteric pathogens, such as Salmonella enterica, have resulted in increased concern regarding the microbiological safety of animal foods. Additionally, the U.S. Food and Drug Administration Food Safety Modernization Act and its implementing rules have stipulated the implementation of current good manufacturing practices and food safety preventive controls for livestock and companion animal foods. Animal foods and feeds are sometimes formulated to include thermally rendered animal by-product meals...
August 3, 2017: Journal of Food Protection
https://www.readbyqxmd.com/read/28763564/the-accuracy-of-static-pressure-measurement-with-water-filled-urodynamic-systems
#6
Andrew Gammie
AIMS: To quantify the inaccuracy of pressure measurement by water-filled systems, with a view to recommending better practice. METHODS: Papers examining quality of measurements were reviewed, and standards documents examined. Technical data from manufacturers were gathered and summarized. Measurements were made on two different urodynamic systems. Individual inaccuracies were combined using the root sum of squares method. RESULTS: The total inaccuracy in measurement may reach up to 9...
August 1, 2017: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/28761170/intravenous-infusion-of-human-bone-marrow-mesenchymal-stromal-cells-promotes-functional-recovery-and-neuroplasticity-after-ischemic-stroke-in-mice
#7
Eliana Sammali, Claudia Alia, Gloria Vegliante, Valentina Colombo, Nadia Giordano, Francesca Pischiutta, Giorgio B Boncoraglio, Mario Barilani, Lorenza Lazzari, Matteo Caleo, Maria-Grazia De Simoni, Giuseppe Gaipa, Giuseppe Citerio, Elisa R Zanier
Transplantation of human bone marrow mesenchymal stromal cells (hBM-MSC) promotes functional recovery after stroke in animal models, but the mechanisms underlying these effects remain incompletely understood. We tested the efficacy of Good Manufacturing Practices (GMP) compliant hBM-MSC, injected intravenously 3.5 hours after injury in mice subjected to transient middle cerebral artery occlusion (tMCAo). We addressed whether hBM-MSC are efficacious and if this efficacy is associated with cortical circuit reorganization using neuroanatomical analysis of GABAergic neurons (parvalbumin; PV-positive cells) and perineuronal nets (PNN), a specialized extracellular matrix structure which acts as an inhibitor of neural plasticity...
July 31, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28753910/practical-use-of-metal-oxide-semiconductor-gas-sensors-for-measuring-nitrogen-dioxide-and-ozone-in-urban-environments
#8
Philip J D Peterson, Amrita Aujla, Kirsty H Grant, Alex G Brundle, Martin R Thompson, Josh Vande Hey, Roland J Leigh
The potential of inexpensive Metal Oxide Semiconductor (MOS) gas sensors to be used for urban air quality monitoring has been the topic of increasing interest in the last decade. This paper discusses some of the lessons of three years of experience working with such sensors on a novel instrument platform (Small Open General purpose Sensor (SOGS)) in the measurement of atmospheric nitrogen dioxide and ozone concentrations. Analytic methods for increasing long-term accuracy of measurements are discussed, which permit nitrogen dioxide measurements with 95% confidence intervals of 20...
July 19, 2017: Sensors
https://www.readbyqxmd.com/read/28752663/platelet-production-from-induced-pluripotent-stem-cells
#9
N Sugimoto, K Eto
Ex vivo production of human platelets has been pursued as an alternative measure to resolve limitations in the supply and safety of current platelet transfusion products. To this end, induced pluripotent stem cells (iPSCs) are considered an ideal global source, as they are not only pluripotent and self-renewing, but are also available from basically any person, have relatively few ethical issues, and are easy to manipulate. From human iPSCs, megakaryocyte (MK) lines with robust proliferation capacity have been established by the introduction of specified sets of genes...
July 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28750854/tularemia-vaccine-safety-reactogenicity-take-skin-reactions-and-antibody-responses-following-vaccination-with-a-new-lot-of-the-francisella-tularensis-live-vaccine-strain-a-phase-2-randomized-clinical-trial
#10
Mark J Mulligan, Jack T Stapleton, Wendy A Keitel, Sharon E Frey, Wilbur H Chen, Nadine Rouphael, Srilatha Edupuganti, Allison Beck, Patricia L Winokur, Hana M El Sahly, Shital M Patel, Robert L Atmar, Irene Graham, Edwin Anderson, Samer S El-Kamary, Marcela F Pasetti, Marcelo B Sztein, Heather Hill, Johannes B Goll
BACKGROUND: Tularemia is caused by Francisella tularensis, a gram-negative bacterium that has been weaponized as an aerosol. For protection of personnel conducting biodefense research, the United States Army required clinical evaluation of a new lot of tularemia live vaccine strain manufactured in accordance with Current Good Manufacturing Practices. METHODS: A phase 2 randomized clinical trial compared the new lot (DVC-LVS) to the existing vaccine that has been in use for decades (USAMRIID-LVS)...
July 24, 2017: Vaccine
https://www.readbyqxmd.com/read/28745336/human-embryonic-stem-cells-and-good-manufacturing-practice-report-of-a-1-day-workshop-held-at-stem-cell-biology-research-center-yazd-27-th-april-2017
#11
Fatemeh Akyash, Fatemeh Sadeghian-Nodoushan, Somayyeh Sadat Tahajjodi, Habib Nikukar, Ehsan Farashahi Yazd, Mostafa Azimzadeh, Harry D Moore, Behrouz Aflatoonian
This report explains briefly the minutes of a 1-day workshop entitled; "human embryonic stem cells (hESCs) and good manufacturing practice (GMP)" held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27(th) April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications...
May 2017: International Journal of Reproductive Biomedicine (Yazd, Iran)
https://www.readbyqxmd.com/read/28736344/tfos-dews-ii-clinical-trial-design-report
#12
REVIEW
Gary D Novack, Penny Asbell, Stefano Barabino, Michael V W Bergamini, Joseph B Ciolino, Gary N Foulks, Michael Goldstein, Michael A Lemp, Stefan Schrader, Craig Woods, Fiona Stapleton
The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED...
July 2017: Ocular Surface
https://www.readbyqxmd.com/read/28736264/mesenchymal-stem-stromal-cell-extracellular-vesicles-from-active-principle-to-next-generation-drug-delivery-system
#13
REVIEW
Barbara Crivelli, Theodora Chlapanidas, Sara Perteghella, Enrico Lucarelli, Luisa Pascucci, Anna Teresa Brini, Ivana Ferrero, Mario Marazzi, Augusto Pessina, Maria Luisa Torre
It has been demonstrated that the biological effector of mesenchymal stem/stromal cells (MSCs) is their secretome, which is composed of a heterogeneous pool of bioactive molecules, partially enclosed in extracellular vesicles (EVs). Therefore, the MSC secretome (including EVs) has been recently proposed as possible alternative to MSC therapy. The secretome can be considered as a protein-based biotechnological product, it is probably safer compared with living/cycling cells, it presents virtually lower tumorigenic risk, and it can be handled, stored and sterilized as an Active Pharmaceutical/Principle Ingredient (API)...
July 20, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28726923/robust-manufacturing-of-lipid-polymer-nanoparticles-through-feedback-control-of-parallelized-swirling-microvortices
#14
Michael J Toth, Taeyoung Kim, YongTae Kim
A variety of therapeutic and/or diagnostic nanoparticles (NPs), or nanomedicines, have been formulated for improved drug delivery and imaging applications. Microfluidic technology enables continuous and highly reproducible synthesis of NPs through controlled mixing processes at the micro- and nanoscale. Yet, the inherent low-throughput remains a critical roadblock, precluding the probable applications of new nanomedicines for clinical translation. Here we present robust manufacturing of lipid-polymer NPs (LPNPs) through feedback controlled operation of parallelized swirling microvortex reactors (SMRs)...
August 8, 2017: Lab on a Chip
https://www.readbyqxmd.com/read/28721305/fully-automated-gmp-production-of-68-ga-ga-do3a-vs-cys-40-exendin-4-for-clinical-use
#15
Irina Velikyan, Ulrika Rosenstrom, Olof Eriksson
[(68)Ga]Ga-DO3A-VS-Cys(40)-Exendin-4/PET-CT targeting glucagon like peptide-1 receptor (GLP-1R) has previously demonstrated its potential clinical value for the detection of insulinomas. The production and accessibility of this radiopharmaceutical is one of the critical factors in realization of clinical trials and routine clinical examinations. Previously, the radiopharmaceutical was prepared manually, however larger scale of clinical trials and healthcare requires automation of the production process in order to limit the operator radiation dose as well as improve tracer manufacturing robustness and on-line documentation for enhanced good manufacturing practice (GMP) compliance...
2017: American Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/28716192/impact-of-fmd-outbreak-on-milk-production-and-heifers-growth-on-a-dairy-herd-in-southern-iran
#16
Maryam Ansari-Lari, Mehdi Mohebbi-Fani, Nicholas A Lyons, Nezamaddin Azizi
Foot and mouth disease is endemic in Middle Eastern countries including Iran but its impact is poorly characterized. The present study was conducted to evaluate the impact of FMD outbreak on milk production and heifers' growth in an industrial dairy herd located in Fars province, southern Iran. Data about individual milk production, heifers' growth and total daily milk (sold for manufacturing), its fat and protein content and somatic cell counts were collected from the herd database. Based on the results of the linear mixed models, a significant decline in individual milk production after the outbreak was observed compared with before the outbreak...
September 1, 2017: Preventive Veterinary Medicine
https://www.readbyqxmd.com/read/28708802/characterization-and-expansion-of-autologous-gmp-ready-regulatory-t-cells-for-treg-based-cell-therapy-in-patients-with-ulcerative-colitis
#17
Caroline J Voskens, Anika Fischer, Susanne Roessner, Carmen Lorenz, Simon Hirschmann, Raja Atreya, Clemens Neufert, Imke Atreya, Markus F Neurath, Gerold Schuler
BACKGROUND: A local imbalance between regulatory (Treg) and effector T cells is believed to play a major role in gut-specific inflammation, including ulcerative colitis (UC). Restoration of this balance through an adoptive Treg transfer is an attractive new treatment approach in patients who are refractory to current standard therapies. It was our goal to develop a Good Manufacturing Practices (GMP)-conform protocol for expansion of UC Treg cells as a rational backbone for future studies on Treg therapy in UC...
August 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28702321/a-high-content-small-molecule-screen-identifies-novel-inducers-of-definitive-endoderm
#18
Alexander Korostylev, Pallavi U Mahaddalkar, Oliver Keminer, Kamyar Hadian, Kenji Schorpp, Philip Gribbon, Heiko Lickert
OBJECTIVES: Human embryonic stem cells (hESCs) and human induced pluripotent stem cells (hiPSCs) can generate any given cell type in the human body. One challenge for cell-replacement therapy is the efficient differentiation and expansion of large quantities of progenitor cells from pluripotent stem cells produced under good manufacturing practice (GMP). FOXA2 and SOX17 double positive definitive endoderm (DE) progenitor cells can give rise to all endoderm-derived cell types in the thymus, thyroid, lung, pancreas, liver, and gastrointestinal tract...
July 2017: Molecular Metabolism
https://www.readbyqxmd.com/read/28679475/cik-as-therapeutic-agents-against-tumors
#19
REVIEW
M Introna
Cytokine Induced Killer (CIK) cells are ex vivo expanded and activated T lymphocytes obtained by sequential incubation of Peripheral Blood Mononuclear cells (PBMNC) with Interferon γ (IFNG), anti CD3 monoclonal antibody OKT3 and IL2. These cells, while retaining few characteristics of the Effector memory T cells subpopulation, acquired during culture CD56 expression, as well as non specific, Natural Killer like, anti tumoral cytotoxicity. CIK cells from human are equivalent to expanded NKT cells in mouse...
July 2, 2017: Journal of Autoimmunity
https://www.readbyqxmd.com/read/28678313/evaluation-of-a-new-imaging-software-for-aortic-endograft-planning
#20
G Tinelli, A Hertault, T Martin Gonzalez, R Spear, R Azzaoui, J Sobocinski, R E Clough, S Haulon
OBJECTIVE: The aim of this study was to evaluate a new 3D Workstation workflow (EVAR Assist, Advantage Windows, GE Healthcare, Chalfont, UK) (EA-AW) designed to simplify complex EVAR planning. PATIENTS AND METHODS: All pre-operative computed tomography (CT) scans of patients who underwent repair at our institution of a complex aortic aneurysm using fenestrated endovascular repair (f-EVAR) between January and September 2014, were reviewed. For each patient, imaging analysis (12 measures: aortic diameters and length and "clock position" of visceral artery) was performed on two different workstations: Aquarius (TeraRecon, San Mateo, CA, USA) and EA-AW...
June 2017: European Review for Medical and Pharmacological Sciences
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