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https://www.readbyqxmd.com/read/29150937/cgmp-production-and-analysis-of-bg505-sosip-664-an-extensively-glycosylated-trimeric-hiv-1-envelope-glycoprotein-vaccine-candidate
#1
Antu K Dey, Albert Cupo, Gabriel Ozorowski, Vaneet K Sharma, Anna-Janina Behrens, Eden P Go, Thomas J Ketas, Anila Yasmeen, Per J Klasse, Eddy Sayeed, Heather Desaire, Max Crispin, Ian A Wilson, Rogier W Sanders, Thomas Hassell, Andrew Ward, John P Moore
We describe the properties of BG505 SOSIP.664 HIV-1 envelope glycoprotein trimers produced under current Good Manufacturing Practice (cGMP) conditions. These proteins are the first of a new generation of native-like trimers that are the basis for many structure-guided immunogen development programs aimed at devising how to induce broadly neutralizing antibodies (bNAbs) to HIV-1 by vaccination. The successful translation of this prototype demonstrates the feasibility of producing similar immunogens on an appropriate scale and of an acceptable quality for Phase I experimental medicine clinical trials...
November 18, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29150848/allergen-manufacturing-and-quality-aspects-for-allergen-immunotherapy-in-europe-and-the-united-states-an-analysis-from-the-eaaci-ait-guidelines-project
#2
REVIEW
A Bonertz, G Roberts, J E Slater, J Bridgewater, R L Rabin, M Hoefnagel, M Timon, C Pini, O Pfaar, A Sheikh, D Ryan, C Akdis, J Goldstein, L K Poulsen, R van Ree, C Rhyner, D Barber, O Palomares, R Pawankar, D Hamerlijnk, L Klimek, I Agache, E Angier, T Casale, M Fernandez-Rivas, S Halken, M Jutel, S Lau, G Pajno, G Sturm, E M Varga, R Gerth van Wijk, S Bonini, A Muraro, S Vieths
Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States...
November 17, 2017: Allergy
https://www.readbyqxmd.com/read/29150596/forming-a-three-dimensional-porous-organic-network-via-solid-state-explosion-of-organic-single-crystals
#3
Seo-Yoon Bae, Dongwook Kim, Dongbin Shin, Javeed Mahmood, In-Yup Jeon, Sun-Min Jung, Sun-Hee Shin, Seok-Jin Kim, Noejung Park, Myoung Soo Lah, Jong-Beom Baek
Solid-state reaction of organic molecules holds a considerable advantage over liquid-phase processes in the manufacturing industry. However, the research progress in exploring this benefit is largely staggering, which leaves few liquid-phase systems to work with. Here, we show a synthetic protocol for the formation of a three-dimensional porous organic network via solid-state explosion of organic single crystals. The explosive reaction is realized by the Bergman reaction (cycloaromatization) of three enediyne groups on 2,3,6,7,14,15-hexaethynyl-9,10-dihydro-9,10-[1,2]benzenoanthracene...
November 17, 2017: Nature Communications
https://www.readbyqxmd.com/read/29150208/development-of-a-synthetic-vi-polysaccharide-vaccine-for-typhoid-fever
#4
Yawei Ni, Michael J Springer, Jianhua Guo, Isaac Finger-Baker, James P Wilson, Ronald R Cobb, Debra Turner, Ian Tizard
Typhoid fever remains a serious public health problem with a high impact on toddlers and young children. Vaccines against the Vi capsular polysaccharide are efficacious against typhoid fever demonstrating that antibodies against Vi confer protection. The currently licensed Vi typhoid vaccines have however limited efficacy and are manufactured by a complex process from wild-type bacteria. Due to these inherent issues with the current vaccines, an alternative vaccine based on an O-acetylated high molecular weight (HMW) polygalacturonic acid (GelSite-OAc™) was generated...
November 14, 2017: Vaccine
https://www.readbyqxmd.com/read/29150132/prosthodontic-rehabilitation-with-monolithic-multichromatic-cad-cam-complete-overdentures-in-an-adolescent-patient-with-ectodermal-dysplasia-a-clinical-report
#5
Hussain D Alsayed, Nasser M Alqahtani, Yasmin M Alzayer, Dean Morton, John A Levon, Nadim Z Baba
Ectodermal dysplasia is a rare, hereditary, congenital disease that affects the normal development of certain tissues and structures of ectodermal origin. The disease is manifested to different degrees of severity and may involve the nose, eyes, hair, nails, sweat glands, and enamel. This report describes a 14-year-old boy with ectodermal dysplasia, rehabilitated with monolithic, multichromatic maxillary and mandibular computer-aided design and computer-aided manufacturing (CAD-CAM) acrylic resin complete overdentures...
November 15, 2017: Journal of Prosthetic Dentistry
https://www.readbyqxmd.com/read/29149837/assessment-of-genetic-diversity-in-vigna-unguiculata-l-walp-accessions-using-inter-simple-sequence-repeat-issr-and-start-codon-targeted-scot-polymorphic-markers
#6
David Okeh Igwe, Celestine Azubike Afiukwa, Benjamin Ewa Ubi, Kenneth Idika Ogbu, Omena Bernard Ojuederie, George Nkem Ude
BACKGROUND: Assessment of genetic diversity of Vigna unguiculata (L.) Walp (cowpea) accessions using informative molecular markers is imperative for their genetic improvement and conservation. Use of efficacious molecular markers to obtain the required knowledge of the genetic diversity within the local and regional germplasm collections can enhance the overall effectiveness of cowpea improvement programs, hence, the comparative assessment of Inter-simple sequence repeat (ISSR) and Start codon targeted (SCoT) markers in genetic diversity of V...
November 17, 2017: BMC Genetics
https://www.readbyqxmd.com/read/29149739/removal-of-tio2-nanoparticles-from-water-by-low-pressure-pilot-plant-filtration
#7
Josune Olabarrieta, Oihane Monzón, Yolanda Belaustegui, Jon-Iñaki Alvarez, Saioa Zorita
Rising use of nanoparticles in manufacturing as well as in commercial products bring issues related to environmental release and human exposure. A large amount of TiO2 nanoparticles will eventually reach wastewater treatment plants. Low pressure membrane filtration has been suggested as a feasible treatment of water streams. This study investigated first at laboratory scale the influence of: i) membrane material, ii) pore size and iii) water chemistry on nTiO2 removal. TiO2 retention was governed by the cake layer formation mechanism and significant retention of nanoparticles was observed even for filters having considerably larger pores than nTiO2...
November 14, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/29149712/detection-of-perfluoroalkyl-acids-and-sulphonates-in-italian-eel-samples-by-hplc-hrms-orbitrap
#8
Luca Maria Chiesa, Maria Nobile, Elisa Pasquale, Claudia Balzaretti, Petra Cagnardi, Doriana Tedesco, Sara Panseri, Francesco Arioli
Perfluoroalkyl substances (PFASs) contain one or more carbon-bound hydrogens substituted by fluorine. Since the 1950s, these compounds have been used to manufacture fat- and water-resistant fabrics, paper and food containers, and to produce photographic films, firefighting foams, detergents and insecticides. The widespread use and global distribution of PFASs, have led to their accumulation in the environment. Food, particularly fish and other seafood, is considered the main route of human exposure to PFASs...
October 27, 2017: Chemosphere
https://www.readbyqxmd.com/read/29149693/near-infrared-spectroscopy-based-monitoring-of-extraction-processes-of-raw-material-with-the-help-of-dynamic-predictive%C3%A2-modeling
#9
Haixia Wang, Tongchuan Suo, Xiaolin Wu, Yue Zhang, Chunhua Wang, Heshui Yu, Zheng Li
The control of batch-to-batch quality variations remains a challenging task for pharmaceutical industries, e.g., traditional Chinese medicine (TCM) manufacturing. One difficult problem is to produce pharmaceutical products with consistent quality from raw material of large quality variations. In this paper, an integrated methodology combining the near infrared spectroscopy (NIRS) and dynamic predictive modeling is developed for the monitoring and control of the batch extraction process of licorice. With the spectra data in hand, the initial state of the process is firstly estimated with a state-space model to construct a process monitoring strategy for the early detection of variations induced by the initial process inputs such as raw materials...
November 10, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/29149211/occupational-exposure-to-unburnt-tobacco-and-potential-risk-of-toxic-optic-neuropathy-a-cross-sectional-study-among-beedi-rollers-in-selected-rural-areas-of-coastal-karnataka-india
#10
Soujanya Kaup, Ansaba Naseer, Siddharudha Shivalli, Cynthia Arunachalam
BACKGROUND: Beedi also known as poor man's cigarette is manufactured in almost all major states of India. Beedi workers are exposed to various health risks. There is an increased risk of systemic absorption of tobacco through skin and mucous membrane. The optic nerve is susceptible to damage from several toxic substances including tobacco. This group of disorders is known as toxic optic neuropathy (TON). The association of TON with occupational exposure to unburnt tobacco in beedi rollers has not been explored...
2017: PloS One
https://www.readbyqxmd.com/read/29149148/current-impact-and-application-of-abuse-deterrent-opioid-formulations-in-clinical-practice
#11
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29149057/effects-of-surfactants-on-the-preparation-of-nanocellulose-pla-composites
#12
Kirsi Immonen, Panu Lahtinen, Jaakko Pere
Thermoplastic composite materials containing wood fibers are gaining increasing interest in the manufacturing industry. One approach is to use nano- or micro-size cellulosic fibrils as additives and to improve the mechanical properties obtainable with only small fibril loadings by exploiting the high aspect ratio and surface area of nanocellulose. In this study, we used four different wood cellulose-based materials in a thermoplastic polylactide (PLA) matrix: cellulose nanofibrils produced from softwood kraft pulp (CNF) and dissolving pulp (CNFSD), enzymatically prepared high-consistency nanocellulose (HefCel) and microcellulose (MC) together with long alkyl chain dispersion-improving agents...
November 17, 2017: Bioengineering
https://www.readbyqxmd.com/read/29149035/wearete-a-scalable-wearable-e-textile-triboelectric-energy-harvesting-system-for-human-motion-scavenging
#13
Xian Li, Ye Sun
In this paper, we report the design, experimental validation and application of a scalable, wearable e-textile triboelectric energy harvesting (WearETE) system for scavenging energy from activities of daily living. The WearETE system features ultra-low-cost material and manufacturing methods, high accessibility, and high feasibility for powering wearable sensors and electronics. The foam and e-textile are used as the two active tribomaterials for energy harvester design with the consideration of flexibility and wearability...
November 17, 2017: Sensors
https://www.readbyqxmd.com/read/29148575/effects-of-spot-parameters-in-pencil-beam-scanning-treatment-planning
#14
Aafke Christine Kraan, Nicolas Depauw, Ben Clasie, Marina Giunta, Tom Madden, Hanne M Kooy
BACKGROUND: Spot size σ (in-air at isocenter), inter-spot spacing d, and spot charge q influence dose delivery efficiency and plan quality in Intensity Modulated Proton Therapy (IMPT) treatment planning. The choice and range of parameters varies among different manufacturers. The goal of this work is to demonstrate the influence of the spot parameters on dose quality and delivery in IMPT treatment plans, to show their interdependence, and to make practitioners aware of the spot parameter values for a certain facility...
November 17, 2017: Medical Physics
https://www.readbyqxmd.com/read/29148548/acrylate-based-materials-for-heart-valve-scaffold-engineering
#15
Rosaria Santoro, Seshasailam Venkateswaran, Francesco Amadeo, Rong Zhang, Maura Brioschi, Anthony Callanan, Marco Agrifoglio, Cristina Banfi, Mark Bradley, Maurizio Pesce
Calcific aortic valve disease (CAVD) is the most frequent cardiac valve pathology. Its standard treatment consists of surgical replacement either with mechanical (metal made) or biological (animal tissue made) valve prostheses, both of which have glaring deficiencies. In the search for novel materials to manufacture artificial valve tissue, we have conducted a high-throughput screening with subsequent up-scaling to identify non-degradable polymer substrates that promote valve interstitial cells (VICs) adherence/growth and, at the same time, prevent their evolution toward a pro-calcific phenotype...
November 17, 2017: Biomaterials Science
https://www.readbyqxmd.com/read/29148218/new-solutions-to-reduce-wrong-route-medication-errors
#16
REVIEW
Ronald S Litman, Victoria I Smith, Phoebe Mainland
Wrong route medication errors due to tubing misconnections are potentially life-threatening complications that have been made possible by the universal use of the Luer connector. The new International Organization of Standardization standards for small bore connectors, ISO 80369 series, have been developed to reduce the risk of these types of erroneous connections. Tubing connectors for different routes of clinical application will contain differently designed connectors that are physically incompatible. However, design and manufacturing standards have progressed slowly, and clinical roll-outs have been delayed, despite the implementation of California laws to promote their use...
November 17, 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/29148121/position-accuracy-of-implant-analogs-on-3d-printed-polymer-versus-conventional-dental-stone-casts-measured-using-a-coordinate-measuring-machine
#17
Marta Revilla-León, Óscar Gonzalez-Martín, Javier Pérez López, José Luis Sánchez-Rubio, Mutlu Özcan
PURPOSE: To compare the accuracy of implant analog positions on complete edentulous maxillary casts made of either dental stone or additive manufactured polymers using a coordinate measuring machine (CMM). MATERIAL AND METHODS: A completely edentulous maxillary model of a patient with 7 implant analogs was obtained. From this model, two types of casts were duplicated, namely conventional dental stone (CDS) using a custom tray impression technique after splinting (N = 5) and polymer cast using additive manufacturing based on the STL file generated...
November 17, 2017: Journal of Prosthodontics: Official Journal of the American College of Prosthodontists
https://www.readbyqxmd.com/read/29148058/classification-of-consumer-products-under-the-eu-clp-regulation-what-to-consider-when-caring-for-contact-dermatitis-patients
#18
REVIEW
Peter Elsner
Possibly hazardous chemical substances and mixtures need to be clearly and correctly classified and labelled, in order for their hazards to be properly identified and communicated. As dermatologists may encounter cases of harm to patients induced by chemicals, such as chemical burns, and irritant and allergic contact dermatitis, it is essential for them to be aware of the EU CLP Regulation and its potential pitfalls. Manufacturers are required by CLP to classify their products according to the rules given in the CLP Regulation...
November 17, 2017: Contact Dermatitis
https://www.readbyqxmd.com/read/29148053/effective-inactivation-of-a-wide-range-of-viruses-by-pasteurization
#19
Albrecht Gröner, Connie Broumis, Randel Fang, Thomas Nowak, Birgit Popp, Wolfram Schäfer, Nathan J Roth
BACKGROUND: Careful selection and testing of plasma reduces the risk of blood-borne viruses in the starting material for plasma-derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood-borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment...
November 16, 2017: Transfusion
https://www.readbyqxmd.com/read/29147994/printability-of-papers-recycled-from-toner-and-inkjet-printed-papers-after-deinking-and-recycling-processes
#20
Arif Karademir, Cem Aydemir, Dogan Tutak, Raja Aravamuthan
BACKGROUND: In our contemporary world, while part of the fibers used in the paper industry is obtained from primary fibers such as wood and agricultural plants, the rest is obtained from secondary fibers from waste papers. To manufacture paper with high optical quality from fibers of recycled waste papers, these papers require deinking and bleaching of fibers at desired levels. High efficiency in removal of ink from paper mass during recycling, and hence deinkability, are especially crucial for the optical and printability quality of the ultimate manufactured paper...
November 11, 2017: Journal of Applied Biomaterials & Functional Materials
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