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https://www.readbyqxmd.com/read/29785887/quality-by-design-process-analytical-technology-gmp-and-regulatory-affairs
#1
Metin Çelik
No abstract text is available yet for this article.
July 2018: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/29784461/stability-and-reactivity-of-%C3%AE-%C3%AE-ptms-silane-in-some-commercial-primer-and-adhesive-formulations
#2
Maria Dimitriadi, Angeliki Panagiotopoulou, Maria Pelecanou, Konstantina Yannakopoulou, George Eliades
OBJECTIVES: To evaluate the stability and reactivity of γ-methacryloxypropyl trimethoxysilane (MPTMS) in commercially available primers and adhesives. METHODS: Four representative primer formulations [Calibra Silane Coupling Agent/Dentsply (CLB), G-Multi Primer/GC (GMP), Kerr Silane Primer/Kerr (KSP), Monobond Plus/Ivoclar Vivadent (MBP)] and a universal adhesive [Scotchbond Universal/3M ESPE (SBU)] containing MPTMS were analyzed spectroscopically. For the stability study, the silanol content was evaluated in bulk solutions as received (reference-RE) and after aging (AG, 48°C/1month) by 1 H, 13 C, 31 P NMR and in fresh films by transmission FTIR analysis (TIR, films applied on Ge windows after solvent evaporation)...
May 18, 2018: Dental Materials: Official Publication of the Academy of Dental Materials
https://www.readbyqxmd.com/read/29782541/an-unappreciated-role-for-neutrophil-dc-hybrids-in-immunity-to-invasive-fungal-infections
#3
J Scott Fites, Michael Gui, John F Kernien, Paige Negoro, Zeina Dagher, David B Sykes, Jeniel E Nett, Michael K Mansour, Bruce S Klein
Neutrophils are classically defined as terminally differentiated, short-lived cells; however, neutrophils can be long-lived with phenotypic plasticity. During inflammation, a subset of neutrophils transdifferentiate into a population called neutrophil-DC hybrids (PMN-DCs) having properties of both neutrophils and dendritic cells. While these cells ubiquitously appear during inflammation, the role of PMN-DCs in disease remains poorly understood. We observed the differentiation of PMN-DCs in pre-clinical murine models of fungal infection: blastomycosis, aspergillosis and candidiasis...
May 21, 2018: PLoS Pathogens
https://www.readbyqxmd.com/read/29781188/a-novel-anti-malarial-drug-derivative-inhibits-cyclic-gmp-amp-synthase-in-trex1-deficient-mice
#4
Jie An, Joshua J Woodward, Weinan Lai, Mark Minie, Xizhang Sun, Lena Tanaka, Jessica M Snyder, Tomikazu Sasaki, Keith B Elkon
OBJECTIVE: Type I interferon (IFN-I) is strongly implicated in the pathogenesis of Systemic Lupus Erythematosus (SLE) as well as rare monogenic 'interferonopathies' such as Aicardi-Goutieres Syndrome (AGS) caused by mutations in the DNA exonuclease, TREX1. The DNA-activated IFN-I pathway, cyclic GMP-AMP (cGAMP) synthase (cGAS), is linked to subsets of AGS and lupus. We identified inhibitors of DNA-cGAS interaction and tested lead candidate, X6, in a mouse model of AGS. METHODS: Trex1-/- mice were treated orally from birth with either X6 or HCQ for 8 weeks...
May 21, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29777732/antinociceptive-effect-of-tadalafil-in-various-pain-models-involvement-of-opioid-receptors-and-nitric-oxide-cyclic-gmp-pathways
#5
Mohammad M Mehanna, Souraya Domiati, Hania Nakkash Chmaisse, Ahmed El Mallah
Nitric oxide has been proven to play an important role in nociception, accordingly, its promoters, phosphodiesterase inhibitors have been investigated as pain response modulators. Aiming to evaluate the central effect of tadalafil, a phosphodiesterase 5 inhibitor, and to determine its EC50, tail flick and hot plate tests were utilized. On the other hand, its nociceptive peripheral analgesic effect was assessed through acetic-acid induced writhing model. Formalin test was used to appraise both non-inflammatory and inflammatory pain responses...
May 16, 2018: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/29769349/hiv-1-activation-of-innate-immunity-depends-strongly-on-the-intracellular-level-of-trex1-and-sensing-of-incomplete-reverse-transcription-products
#6
Swati Kumar, James H Morrison, David Dingli, Eric Poeschla
TREX1 has been reported to degrade cytosolic immune-stimulatory DNA, including viral DNA generated during HIV-1 infection, but the dynamic range of its capacity to suppress innate immune stimulation is unknown and its full role in the viral life cycle remains unclear. A main purpose of our study was to determine how the intracellular level of TREX1 affects HIV-1 activation and avoidance of innate immunity. Using stable over-expression and CRISPR-mediated gene disruption, we engineered a range of TREX1 levels in human THP-1 monocytes...
May 16, 2018: Journal of Virology
https://www.readbyqxmd.com/read/29766671/point-of-care-treatment-of-focal-cartilage-defects-with-selected-chondrogenic-mesenchymal-stromal-cells-an-in-vitro-proof-of-concept-study
#7
Oliver Petters, Christian Schmidt, Christian Thuemmler, Frank Peinemann, Matthias Zscharnack, Jeremy S Somerson, Ronny M Schulz
Due to the poor self-healing capacities of cartilage, innovative approaches are a major clinical need. The use of in vitro expanded MSCs in a two-stage approach is accompanied by cost, time and personnel-intensive GMP production. A one-stage intra-operative procedure could overcome these drawbacks. The aim was to prove the feasibility of a point-of-care concept for the treatment of cartilage lesions using defined MSC subpopulations in a collagen hydrogel without prior MSC monolayer expansion. We tested four single marker candidates (MSCA-1, W4A5, CD146, CD271) for their effectiveness of separating colony-forming units of ovine MSCs via magnetic cell separation...
May 15, 2018: Journal of Tissue Engineering and Regenerative Medicine
https://www.readbyqxmd.com/read/29764763/direct-recovery-of-mangostins-from-garcinia-mangostana-pericarps-using-cellulase-assisted-aqueous-micellar-biphasic-system-with-recyclable-surfactant
#8
Hui-Suan Ng, Grace Yin Tze Tan, Ka-Heng Lee, Wolfgang Zimmermann, Hip Seng Yim, John Chi-Wei Lan
The α- and γ-mangostins from Garcinia mangostana pericarps (GMP) exhibit antioxidant, anti-bacterial, anti-inflammatory and anti-tumor properties. The extraction yields α- and γ-mangostins are often limited by the presence of the GMP cell walls. Therefore, the extraction and recovery of mangostins from GMP with an Aspergillus niger cellulase-assisted aqueous micellar biphasic system (CA-AMBS) was developed for enhanced yield of mangostins. Effects of the concentration of cellulase, the incubation time and the temperature of the system on the recovery of mangostins were investigated...
May 12, 2018: Journal of Bioscience and Bioengineering
https://www.readbyqxmd.com/read/29760876/rinck-mediated-monoubiquitination-of-cgas-promotes-antiviral-innate-immune-responses
#9
Zhao-Shan Liu, Zi-Yu Zhang, Hong Cai, Ming Zhao, Jie Mao, Jiang Dai, Tian Xia, Xue-Min Zhang, Tao Li
Background: As an important danger signal, the presence of DNA in cytoplasm triggers potent immune responses. Cyclic GMP-AMP synthase (cGAS) is a recently characterized key sensor for cytoplasmic DNA. The engagement of cGAS with DNA leads to the synthesis of a second messenger, cyclic GMP-AMP (cGAMP), which binds and activates the downstream adaptor protein STING to promote type I interferon production. Although cGAS has been shown to play a pivotal role in innate immunity, the exact regulation of cGAS activation is not fully understood...
2018: Cell & Bioscience
https://www.readbyqxmd.com/read/29760209/complex-control-of-a-genomic-island-governing-biofilm-and-rugose-colony-development-in-vibrio-vulnificus
#10
Daniel M Chodur, Dean A Rowe-Magnus
V. vulnificus is a potent opportunistic human pathogen that contaminates the human food-chain by asymptomatically colonizing seafood. Expression of the 9-gene brp exopolysaccharide locus mediates surface adherence and is controlled by the secondary signaling molecule c-di-GMP and the regulator BrpT. Here, we show that c-di-GMP and BrpT also regulate the expression of an adjacent 5-gene cluster that includes the cabABC operon, brpT and another VpsT-like transcriptional regulator, brpS The expression of the 14 genes spanning the region increased with elevated intracellular c -di-GMP levels in a BrpT-dependent manner, save brpS , which was positively regulated by c-di-GMP and repressed by BrpT...
May 14, 2018: Journal of Bacteriology
https://www.readbyqxmd.com/read/29755973/identification-of-loop-d-domain-amino-acids-in-the-human-aquaporin-1-channel-involved-in-activation-of-the-ionic-conductance-and-inhibition-by-aqb011
#11
Mohamad Kourghi, Michael L De Ieso, Saeed Nourmohammadi, Jinxin V Pei, Andrea J Yool
Aquaporins are integral proteins that facilitate the transmembrane transport of water and small solutes. In addition to enabling water flux, mammalian Aquaporin-1 (AQP1) channels activated by cyclic GMP can carry non-selective monovalent cation currents, selectively blocked by arylsulfonamide compounds AqB007 (IC50 170 μM) and AqB011 (IC50 14 μM). In silico models suggested that ligand docking might involve the cytoplasmic loop D (between AQP1 transmembrane domains 4 and 5), but the predicted site of interaction remained to be tested...
2018: Frontiers in Chemistry
https://www.readbyqxmd.com/read/29755546/occurrence-of-ochratoxin-a-in-grape-juice-of-iran
#12
Jamal Yusefi, Mehran Valaee, Firouzeh Nazari, Javad Maleki, Ehsan Mottaghianpour, Roya Khosrokhavar, Mir-Jamal Hosseini
Ochratoxin A (OTA) is one of the most important mycotoxins that contaminate a broad range of agricultural and food products. In this study, the occurrence of OTA in available brands of grape juice in Iran purchased from retail outlets or producer were determined for the first time using high-performance liquid chromatography (HPLC) with immunoaffinity columns(IAC) as the clean-up step. The average recoveries for OTA in grape juice ranged from 54.2 to 86.6% with the coefficient of variation lower than 17.3% in lowest spiked level (0...
2018: Iranian Journal of Pharmaceutical Research: IJPR
https://www.readbyqxmd.com/read/29755425/identification-and-characterization-of-c-di-gmp-metabolic-enzymes-of-leptospira-interrogans-and-c-di-gmp-fluctuations-after-thermal-shift-and-infection
#13
Guohui Xiao, Liangliang Kong, Rongbo Che, Yusi Yi, Qinchao Zhang, Jie Yan, Xu'ai Lin
Leptospirosis is a widespread zoonotic disease caused by pathogenic Leptospira species. The most common species, Leptospira interrogans , can transfer from contaminated soil or water to the human body. It is able to survive these changing environments through sensing and responding to the changes of environmental cues. Cyclic di-GMP (c-di-GMP) is a special secondary messenger in bacteria, which can respond to the environment and regulate diverse bacterial behaviors. The c-di-GMP levels in bacterial cells are regulated by diguanylatecyclases (DGC) and phosphodiesterases (PDE), which are responsible for synthesizing or hydrolyzing c-di-GMP, respectively...
2018: Frontiers in Microbiology
https://www.readbyqxmd.com/read/29754770/skewing-effect-of-sulprostone-on-dendritic-cell-maturation-compared-with-dinoprostone
#14
Jenny Bulgarelli, Laura Fiammenghi, Serena Cassan, Anna Maria Granato, Massimiliano Petrini, Elena Pancisi, Valentina Soldati, Francesco De Rosa, Laura Ridolfi, Angela Riccobon, Massimo Guidoboni
BACKGROUND: Dendritic cells (DCs) are the most efficient antigen-presenting cells and act at the center of the immune system owing to their ability to control both immune tolerance and immunity. In cancer immunotherapy, DCs play a key role in the regulation of the immune response against tumors and can be generated ex vivo with different cytokine cocktails. METHODS: We evaluated the feasibility of dinoprostone (PGE2 ) replacement with the molecular analog sulprostone, in our good manufacturing practice (GMP) protocol for the generation of DC-based cancer vaccine...
May 10, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29753142/heme-oxygenase-1-inhibits-spring-viremia-of-carp-virus-replication-through-carbon-monoxide-mediated-cyclic-gmp-protein-kinase-g-signaling-pathway
#15
Cong Li, Lijuan Li, Ling Jin, Junfa Yuan
Spring viremia of carp virus (SVCV) is the etiological agent of spring viremia of carp (SVC) and causes mass mortality in common carp (Cyprinus carpio). Currently, no effective treatments or commercial vaccines against SVCV are available. Heme oxygenase-1 (HO-1), an enzyme that catalyzes the degradation of heme to produce carbon monoxide (CO), biliverdin and ferrous iron (Fe2+), exerts anti-oxidant, antiinflammatory and anti-apoptotic properties. Previous studies demonstrated that nuclear factor-erythroid 2 related factor 2 (Nrf2) functions as an important upstream regulator of HO-1 and exhibits robust activity against SVCV infection...
May 9, 2018: Fish & Shellfish Immunology
https://www.readbyqxmd.com/read/29751821/improved-gmp-compliant-approach-to-manipulate-lipoaspirates-to-cryopreserve-stromal-vascular-fraction-and-to-expand-adipose-stem-cells-in-xeno-free-media
#16
Francesco Agostini, Francesca Maria Rossi, Donatella Aldinucci, Monica Battiston, Elisabetta Lombardi, Stefania Zanolin, Samuele Massarut, Pier Camillo Parodi, Alessandro Da Ponte, Giovanni Tessitori, Barbara Pivetta, Cristina Durante, Mario Mazzucato
BACKGROUND: The stromal vascular fraction (SVF) derived from adipose tissue contains adipose-derived stromal/stem cells (ASC) and can be used for regenerative applications. Thus, a validated protocol for SVF isolation, freezing, and thawing is required to manage product administration. To comply with Good Manufacturing Practice (GMP), fetal bovine serum (FBS), used to expand ASC in vitro, could be replaced by growth factors from platelet concentrates. METHODS: Throughout each protocol, GMP-compliant reagents and devices were used...
May 11, 2018: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/29751298/role-of-cyclic-diguanylate-in-affecting-microbial-community-shifts-at-different-ph-during-the-operation-of-simultaneous-partial-nitrification-anammox-and-denitrification-process
#17
Chao Wang, Sitong Liu, Xiaochen Xu, Yongzhao Guo, Fenglin Yang, Dong Wang
The intracellular cyclic diguanylate acid (c-di-GMP) has emerged as a prominent second signal molecule that coordinates sessile-motile transition and biofilm formation in many bacteria. Herein, we study the role of c-di-GMP in affecting microbial community shifts at different pH levels during simultaneous partial nitrification, anammox and denitrification process (SNAD) in integrated fixed film activated sludge (IFAS) reactor. The results demonstrated that the contents of c-di-GMP notably decreased in suspended sludge, whereas the contents of c-di-GMP in biofilm had no significant change as pH gradually increased from 7...
May 8, 2018: Science of the Total Environment
https://www.readbyqxmd.com/read/29746488/development-of-endocytosis-degradative-activity-and-antigen-processing-capacity-during-gm-csf-driven-differentiation-of-murine-bone-marrow
#18
Adesola C Olatunde, Laura P Abell, Ashley E Landuyt, Elizabeth Hiltbold Schwartz
Dendritic cells (DC) are sentinels of the immune system, alerting and enlisting T cells to clear pathogenic threats. As such, numerous studies have demonstrated their effective uptake and proteolytic activities coupled with antigen processing and presentation functions. Yet, less is known about how these cellular mechanisms change and develop as myeloid cells progress from progenitor cells to more differentiated cell types such as DC. Thus, our study comparatively examined these functions at different stages of myeloid cell development driven by the GM-CSF...
2018: PloS One
https://www.readbyqxmd.com/read/29745976/analysis-and-evaluation-of-the-characteristic-taste-components-in-portobello-mushroom
#19
Jinbin Wang, Wen Li, Zhengpeng Li, Wenhui Wu, Xueming Tang
To identify the characteristic taste components of the common cultivated mushroom (brown; Portobello), Agaricus bisporus, taste components in the stipe and pileus of Portobello mushroom harvested at different growth stages were extracted and identified, and principal component analysis (PCA) and taste active value (TAV) were used to reveal the characteristic taste components during the each of the growth stages of Portobello mushroom. In the stipe and pileus, 20 and 14 different principal taste components were identified, respectively, and they were considered as the principal taste components of Portobello mushroom fruit bodies, which included most amino acids and 5'-nucleotides...
May 10, 2018: Journal of Food Science
https://www.readbyqxmd.com/read/29745348/automated-synthesis-of-68ga-dota-toc-methodological-aspects-and-suitable-technical-solutions-for-a-cationic-purification-system
#20
Licia Uccelli, Alessandra Boschi, Corrado Cittanti, Petra Martini, Luca Lodi, Elisa Zappaterra, Simona Romani, Samanta Zaccaria, Davide Cecconi, Ilaria Rambaldi, Ivan Santi, Stefano Panareo, Melchiore Giganti, Mirco Bartolomei
The PET Gallium-68 isotope has the advantage of being produced from a generator, so it is also available in nuclear medicine departments without a cyclotron. The preparation of Ga-68 DOTA-labelled compounds is actually performed by remotely controlled automated systems developed in order to assure production efficiency, reproducibility of the results, guarantee fast reaction time, to facilitate the synthesis and minimize the radiation exposure. Many automatic synthesis systems are available on the radiopharmaceutical market, and each of these requires the realization of some technical adaptations for routine use...
May 8, 2018: Current Radiopharmaceuticals
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