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Quality system regulations

Didier Lecointe, Jade Assoukpa, Lauriane Cezard, Carole Descaves, Armelle Gouot, Sandrine Bourgeois, Monique Bergeon, Stéphane Koutcherenko, Yasmine Lakhdari, Noura Kassidi
The microbiological tests on breast milk performed when samples of pasteurized breast milk are added to hospital milk banks are covered by French regulations dating from December 3(rd) 2007. They involve counts of the aerobic total flora and of Staphylococcus aureus in a sample of milk before pasteurization, and culture after pasteurization to check that the treated milk is sterile. The regulations specify the nature of the agar plates to be used, together with the conditions for plating and incubation, but they lack detail in other areas...
October 24, 2016: Annales de Biologie Clinique
Koichi Wakabayashi, Fumiaki Mori, Akiyoshi Kakita, Hitoshi Takahashi, Shinya Tanaka, Jun Utsumi, Hidenao Sasaki
MicroRNAs (miRNAs) are small noncoding RNAs that regulate gene expression. Recently, we have shown that informative miRNA data can be derived from archived formalin-fixed paraffin-embedded (FFPE) samples from postmortem cases of amyotrophic lateral sclerosis and normal controls. miRNA analysis has now been performed on FFPE samples from affected brain regions in patients with multiple system atrophy (MSA) and the same areas in neurologically normal controls. We evaluated 50 samples from patients with MSA (n=13) and controls (n=13)...
October 20, 2016: Neuroscience Letters
Rita Langasco, Barbara Cadeddu, Marilena Formato, Antonio Junior Lepedda, Massimo Cossu, Paolo Giunchedi, Roberto Pronzato, Giovanna Rassu, Renata Manconi, Elisabetta Gavini
The growing interest in the use of recyclable and biodegradable natural materials has become a relevant topic in pharmaceutics. In this work, we suggest the use and valorization of natural horny skeleton of marine sponges (Porifera, Dictyoceratida) as bio-based dressing for topical drug delivery. Biomaterial characterization focusing on morpho-functional traits, swelling behavior, fluid uptake performances, glycosaminoglycans content and composition and microbiological quality assessment was carried out to investigate the collagenic skeleton properties...
January 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
Mareike Kroll, Revati Phalkey, Sayani Dutta, Sharvari Shukla, Carsten Butsch, Erach Bharucha, Frauke Kraas
BACKGROUND: Despite the rising impact of non-communicable diseases (NCDs) on public health in India, lack of quality data and routine surveillance hampers the planning process for NCD prevention and control. Current surveillance programs focus largely on communicable diseases and do not adequately include the private healthcare sector as a major source of care in cities. OBJECTIVE: The objective of the study was to conceptualize, implement, and evaluate a prototype for an urban NCD sentinel surveillance system among private healthcare practitioners providing primary care in Pune, India...
2016: Global Health Action
Vibhuti Joshi, Ayeman Amanullah, Arun Upadhyay, Ribhav Mishra, Amit Kumar, Amit Mishra
Cells regularly synthesize new proteins to replace old and abnormal proteins for normal cellular functions. Two significant protein quality control pathways inside the cellular milieu are ubiquitin proteasome system (UPS) and autophagy. Autophagy is known for bulk clearance of cytoplasmic aggregated proteins, whereas the specificity of protein degradation by UPS comes from E3 ubiquitin ligases. Few E3 ubiquitin ligases, like C-terminus of Hsc70-interacting protein (CHIP) not only take part in protein quality control pathways, but also plays a key regulatory role in other cellular processes like signaling, development, DNA damage repair, immunity and aging...
2016: Frontiers in Molecular Neuroscience
Bryan S Der, Emerson Glassey, Bryan A Bartley, Casper Enghuus, Daniel B Goodman, D Benjamin Gordon, Christopher A Voigt, Thomas E Gorochowski
DNAplotlib ( is a computational toolkit for the programmable visualization of highly customizable, standards-compliant genetic designs. Functions are provided to aid with both visualization tasks and to extract and overlay associated experimental data. High-quality output is produced in the form of vector-based PDFs, rasterized images, and animated movies. All aspects of the rendering process can be easily customized or extended by the user to cover new forms of genetic part or regulation...
October 17, 2016: ACS Synthetic Biology
Martin Gamerdinger
The biogenesis of new polypeptides by ribosomes and their subsequent correct folding and localization to the appropriate cellular compartments are essential key processes to maintain protein homoeostasis. These complex mechanisms are governed by a repertoire of protein biogenesis factors that directly bind to the ribosome and chaperone nascent polypeptide chains as soon as they emerge from the ribosomal tunnel exit. This nascent chain 'welcoming committee' regulates multiple co-translational processes including protein modifications, folding, targeting and degradation...
October 15, 2016: Essays in Biochemistry
Ignat Printsev, Daniel Curiel, Kermit L Carraway
The canonical function of the endoplasmic reticulum-associated degradation (ERAD) system is to enforce quality control among membrane-associated proteins by targeting misfolded secreted, intra-organellar, and intramembrane proteins for degradation. However, increasing evidence suggests that ERAD additionally functions in maintaining appropriate levels of a subset of membrane-associated proteins. In this 'quantity control' capacity, ERAD responds to environmental cues to regulate the proteasomal degradation of specific ERAD substrates according to cellular need...
October 14, 2016: Journal of Membrane Biology
James Snyder, Abigail Gewirtz, Lynn Schrepferman, Suzanne R Gird, Jamie Quattlebaum, Michael R Pauldine, Katie Elish, Osnat Zamir, Charles Hayes
Transactional cascades among child internalizing and externalizing symptoms, and fathers' and mothers' posttraumatic stress disorder (PTSD) symptoms were examined in a sample of families with a male parent who had been deployed to recent military conflicts in the Middle East. The role of parents' positive engagement and coercive interaction with their child, and family members' emotion regulation were tested as processes linking cascades of parent and child symptoms. A subsample of 183 families with deployed fathers and nondeployed mothers and their 4- to 13-year-old children who participated in a randomized control trial intervention (After Deployment: Adaptive Parenting Tools) were assessed at baseline prior to intervention, and at 12 and 24 months after baseline, using parent reports of their own and their child's symptoms...
November 2016: Development and Psychopathology
Sophie Braga-Lagache, Natasha Buchs, Mircea-Ioan Iacovache, Benoit Zuber, Christopher Benjamin Jackson, Manfred Heller
BACKGROUND: Cells of the vascular system release spherical vesicles, called microparticles, in the size range of 0.1-1μm induced by a variety of stress factors resulting in variable concentrations between health and disease. Furthermore, microparticles have intercellular communication/signaling properties and interfere with inflammation and coagulation pathways. Today's most used analytical technology for mecroparticle characterization, flow cytometry, is lacking sensitivity and specificity, which might have led to the publication of contradicting results in the past...
October 12, 2016: Molecular & Cellular Proteomics: MCP
Jeonghun Yeom, Mohammad Humayun Kabir, Byungho Lim, Hee-Sung Ahn, Seon-Young Kim, Cheolju Lee
Variations in protein coding sequence may sometimes play important roles in cancer development. However, since variants may not express into proteins due to various cellular quality control systems, it is important to get protein-level evidence of the genomic variations. We present a proteogenomic strategy getting protein-level evidence of genomic variants, which we call sequential targeted LC-MS/MS based on prediction of peptide pI and Retention time (STaLPIR). Our approach shows improved peptide identification, and has the potential for the unbiased analysis of variant sequence as well as corresponding reference sequence...
October 13, 2016: Scientific Reports
Leilei Zhong, Xiaobin Huang, Emilie Dooms Rodrigues, Jeroen Leijten, Theo Verrips, Mohamed El Khattabi, Marcel Karperien, Janine N Post
Hypertrophic differentiation occurs during in vitro chondrogenesis of mesenchymal stem cells (MSCs), decreasing the quality of the cartilage construct. Previously we identified WNT pathway antagonists Dickkopf 1 homolog (DKK1) and frizzled-related protein (FRZB) as key factors in blocking hypertrophic differentiation of hMSCs. In this study, we investigated the role of endogenously expressed DKK1 and FRZB in chondrogenesis of hMSC, chondrocyte redifferentiation and in preventing cell hypertrophy using three relevant human cell based systems, isolated hMSCs, isolated primary human chondrocytes (hChs), and co-cultures of hMSCs with hChs for which we specifically designed neutralizing nano-antibodies...
October 12, 2016: Stem Cells and Development
Amy Tanti, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems...
October 12, 2016: Expert Opinion on Drug Safety
Anca Macovei, Andrea Pagano, Paola Leonetti, Daniela Carbonera, Alma Balestrazzi, Susana S Araújo
The pre-germinative metabolism is among the most fascinating aspects of seed biology. The early seed germination phase, or pre-germination, is characterized by rapid water uptake (imbibition), which directs a series of dynamic biochemical events. Among those are enzyme activation, DNA damage and repair, and use of reserve storage compounds, such as lipids, carbohydrates and proteins. Industrial seedling production and intensive agricultural production systems require seed stocks with high rate of synchronized germination and low dormancy...
October 11, 2016: Plant Cell Reports
Fahim Nawaz, Muhammad Naeem, Muhammad Y Ashraf, Muhammad N Tahir, Bilal Zulfiqar, Muhammad Salahuddin, Rana N Shabbir, Muhammad Aslam
Climate change is one of the most complex challenges that pose serious threats to livelihoods of poor people who rely heavily on agriculture and livestock particularly in climate-sensitive developing countries of the world. The negative effects of water scarcity, due to climate change, are not limited to productivity food crops but have far-reaching consequences on livestock feed production systems. Selenium (Se) is considered essential for animal health and has also been reported to counteract various abiotic stresses in plants, however, understanding of Se regulated mechanisms for improving nutritional status of fodder crops remains elusive...
2016: Frontiers in Plant Science
Pablo Achurra, Antonia Lagos, Ruben Avila, Rodrigo Tejos, Erwin Buckel, Juan Alvarado, Camilo Boza, Nicolas Jarufe, Julian Varas
Introduction Simulated laparoscopy training is limited by its low-quality image. A high-definition (HD) laparoscopic training box was developed under the present necessity of simulating advanced surgery. Objective To describe and test a new HD laparoscopic training box for advanced simulation training. Methods We describe the features and image quality of the new training box. The simulator was tested and then evaluated by a group of 76 expert surgeons using a 4-item questionnaire. To assess the effectiveness of training using this simulation box, 15 general surgery residents were trained to perform a laparoscopic jejuno-jejunostomy in a validated simulation program...
October 10, 2016: Surgical Innovation
Ka Hei Chan, Rahul Krishnan, Michael Alexander, Jonathan Rt Lakey
The islets of Langerhans are endocrine tissue clusters that secrete hormones that regulate the body's glucose, carbohydrate and fat metabolism, the most important of which is insulin, a hormone secreted by β cells within the islets. In certain instances, a person's own immune system attacks and destroys them leading to the development of Type 1 diabetes (T1D), a lifelong condition that needs daily insulin administration to maintain health and prolong survival. Islet transplantation is a surgical procedure that has demonstrated the ability to normalize blood sugar levels for up to a few years, but the need for chronic immunosuppression relegates it to a last resort that is often only used sparingly, and in seriously-ill patients...
October 10, 2016: Cell Transplantation
Marta Silva, José Tiago Costa-Pereira, Daniel Martins, Isaura Tavares
Diabetic neuropathy has a profound impact in the quality of life of patients who frequently complain of pain. The mechanisms underlying diabetic neuropathic pain (DNP) are no longer ascribed only to damage of peripheral nerves. The effects of diabetes at the central nervous system are currently considered causes of DPN. Management of DNP may be achieved by antidepressants that act on serotonin (5-HT) uptake, namely specific serotonin reuptake inhibitors. The rostroventromedial medulla (RVM) is a key pain control center involved in descending pain modulation at the spinal cord through local release of 5-HT and plays a peculiar role in the balance of bidirectional control (i...
October 4, 2016: Neurobiology of Disease
Maria J Gunnarsdottir, Sigurdur M Gardarsson, Gunnar St Jonsson, Jamie Bartram
Assuring sufficient quality of drinking water is of great importance for public wellbeing and prosperity. Nations have developed regulatory system with the aim of providing drinking water of sufficient quality and to minimize the risk of contamination of the water supply in the first place. In this study the chemical quality of Icelandic drinking water was evaluated by systematically analyzing results from audit monitoring where 53 parameters were assessed for 345 samples from 79 aquifers, serving 74 water supply systems...
September 26, 2016: International Journal of Hygiene and Environmental Health
P Kokkinos, I Kozyra, S Lazic, K Söderberg, P Vasickova, M Bouwknegt, S Rutjes, K Willems, R Moloney, A M de Roda Husman, A Kaupke, E Legaki, M D'Agostino, N Cook, C-H von Bonsdorff, A Rzeżutka, T Petrovic, L Maunula, I Pavlik, A Vantarakis
This study condenses data acquired during investigations of the virological quality of irrigation water used in production of fresh produce. One hundred and eight samples of irrigation water were collected from five berry fruit farms in Finland (1), the Czech Republic (1), Serbia (2), and Poland (1), and sixty-one samples were collected from three leafy green vegetable farms in Poland, Serbia, and Greece. Samples were analyzed for index viruses of human or animal fecal contamination (human and porcine adenoviruses, and bovine polyoma viruses), and human pathogenic viruses (hepatitis A virus, hepatitis E virus, and noroviruses GI/GII)...
October 5, 2016: Food and Environmental Virology
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