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https://www.readbyqxmd.com/read/29334871/biomonitoring-of-arsenic-in-woodworkers-exposed-to-cca-and-evaluation-of-other-non-occupational-sources-in-uruguay
#1
Valery Bühl, María Cristina Álvarez, María H Torre, Mariela Pistón, Nelly Mañay
In Uruguay wood-impregnation plants use chromated copper arsenate (CCA) as preservative applying good manufacture practices (GMP). This study aims a retrospective evaluation of toxicologically relevant species levels in CCA exposed woodworker's urine (As-U) and an assessment of the effects of work risk factors and non-occupational sources in As-U of workers from a selected plant. From 2014 to 2016, As-U in 212 urine samples (As-U) of 73 woodworkers from six CCA impregnation plants were determined. In one of these plants, 35 workers were interviewed to obtain individual data of work tasks, lifestyles, diet, habits, etc...
January 15, 2018: International Journal of Occupational and Environmental Health
https://www.readbyqxmd.com/read/29331266/human-papilloma-virus-specific-t-cells-can-be-generated-from-na%C3%A3-ve-t-cells-for-use-as-an-immunotherapeutic-strategy-for-immunocompromised-patients
#2
Sarah E McCormack, Conrad Russell Y Cruz, Kaylor E Wright, Allison B Powell, Haili Lang, Cornelia Trimble, Michael D Keller, Ephraim Fuchs, Catherine M Bollard
Human papilloma virus (HPV) is a known cause of cervical cancer, squamous cell carcinoma and laryngeal cancer. Although treatments exist for HPV-associated malignancies, patients unresponsive to these therapies have a poor prognosis. Recent findings from vaccine studies suggest that T-cell immunity is essential for disease control. Because Epstein-Barr Virus (EBV)-specific T cells have been highly successful in treating or preventing EBV-associated tumors, we hypothesized that the development of a manufacturing platform for HPV-specific T cells from healthy donors could be used in a third-party setting to treat patients with high-risk/relapsed HPV-associated cancers...
January 10, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29322348/optimisation-of-a-potency-assay-for-the-assessment-of-immunomodulative-potential-of-clinical-grade-multipotent-mesenchymal-stromal-cells
#3
Irene Oliver-Vila, Carmen Ramírez-Moncayo, Marta Grau-Vorster, Sílvia Marín-Gallén, Marta Caminal, Joaquim Vives
Clinical use of multipotent Mesenchymal Stromal Cell (MSC)-based medicinal products requires their production in compliance with Good Manufacturing Practices, thus ensuring that the final drug product meets specifications consistently from batch to batch in terms of cell viability, identity, purity and potency. Potency relates to the efficacy of the medicine in its target clinical indication, so adequate release tests need to be defined and validated as quality controls. Herein we report the design and optimisation of parameters affecting the performance of an in vitro cell-based assay for assessing immunomodulatory potential of clinical grade MSC for human use, based on their capacity to inhibit proliferation of T lymphocytes under strong polyclonal stimuli...
January 10, 2018: Cytotechnology
https://www.readbyqxmd.com/read/29321569/xeno-free-pre-vascularized-spheroids-for-therapeutic-applications
#4
E Bauman, T Feijão, D T O Carvalho, P L Granja, C C Barrias
Spheroid culture has gained increasing popularity, arising as a promising tool for regenerative medicine applications. Importantly, spheroids may present advantages over single-cell suspensions in cell-based therapies (CT). Unfortunately, most growth media used for spheroid culture contain animal origin-components, such as fetal bovine serum (FBS). The presence of FBS compromises the safety of CT and presents economic and ethical constraints. SCC (supplement for cell culture) is a novel xeno-free (XF) industrial cell culture supplement, derived from well-controlled pooled human plasma and processed under good manufacturing practice rules...
January 10, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29320232/barriers-to-the-adoption-of-wearable-sensors-in-the-workplace-a-survey-of-occupational-safety-and-health-professionals
#5
Mark C Schall, Richard F Sesek, Lora A Cavuoto
OBJECTIVE: To gather information on the (a) types of wearable sensors, particularly personal activity monitors, currently used by occupational safety and health (OSH) professionals; (b) potential benefits of using such technologies in the workplace; and (c) perceived barriers preventing the widespread adoption of wearable sensors in industry. BACKGROUND: Wearable sensors are increasingly being promoted as a means to improve employee health and well-being, and there is mounting evidence supporting their use as exposure assessment and personal health tools...
January 1, 2018: Human Factors
https://www.readbyqxmd.com/read/29319535/scalable-and-physiologically-relevant-microenvironments-for-human-pluripotent-stem-cell-expansion-and-differentiation
#6
Qiang Li, Haishuang Lin, Qian Du, Kan Liu, Ou Wang, Catelyn Antionette Evans, Hannah Marie Christian, Chi Zhang, Yuguo Lei
Human pluripotent stem cells (hPSCs) are required in large numbers for various biomedical applications. However, the scalable and cost-effective culturing of high quality hPSCs and their derivatives remains very challenging. Here, we report a novel and physiologically relevant 3D culture system (called the AlgTube cell culture system) for hPSC expansion and differentiation. With this system, cells are processed into and cultured in microscale alginate hydrogel tubes that are suspended in the cell culture medium in a culture vessel...
January 10, 2018: Biofabrication
https://www.readbyqxmd.com/read/29304838/a-protocol-to-isolate-and-qualify-purified-human-preantral-follicles-in-cases-of-acute-leukemia-for-future-clinical-applications
#7
Elodie Mouloungui, Tristan Zver, Christophe Roux, Clotilde Amiot
BACKGROUND: Autotransplantation of cryopreserved ovarian cortex can be associated with a risk of cancer cell reseeding. This issue could be eliminated by grafting isolated preantral follicles. Collagenase NB6 is an enzyme produced under good manufacturing practices (GMP) in compliance with requirements for tissue engineering and transplantation in humans and thus can be used to isolate preantral follicles from ovarian tissue in the framework of further clinical applications. Multicolor flow cytometry is an effective tool to evaluate the potential contamination of follicular suspensions by leukemic cells...
January 5, 2018: Journal of Ovarian Research
https://www.readbyqxmd.com/read/29285110/large-scale-ex-vivo-expansion-of-clinical-grade-effector-cells-for-adoptive-immunotherapy
#8
Huiying Yu, Wei Chen, Changling Li, Di Lin, Junde Liu, Zien Yang, Jingang Yang, Yinghui Sun, Dongchu Ma
Cell-based adoptive immunotherapy for the treatment of various cancer types has attracted the attention of scientists. However, due to the absence of unitary standard protocols to produce large quantities of clinical-grade effector cells, it remains challenging to translate the experimental findings into clinical applications. The present study used methods complying with good manufacturing practice to induce effector cells from human peripheral blood mononuclear cells (PBMCs) of healthy donors by interleukin-2 and anti-Her-2 antibody with or without anti-CD3 antibodies (OKT3)...
December 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/29247437/the-french-national-authority-for-health-has-guidelines-for-conducting-budget-impact-analyses-bia
#9
REVIEW
Salah Ghabri, Erwan Autin, Anne-Isabelle Poullié, Jean Michel Josselin
BACKGROUND: Budget impact analysis (BIA) provides short- and medium-term estimates on changes in budgets and health outcomes resulting from the adoption of new health interventions. OBJECTIVE: The purpose of this study is to present the newly developed French National Authority for Health (HAS) guidelines on budget impact analysis as follows: process, literature review, recommendations and comparisons with other guidelines. METHODS: The development process of the HAS guidelines included a literature review (search dates: January 2000 to June 2016), a retrospective investigation of BIA previously submitted to HAS, a public consultation, international expert reviews and approval from the HAS Board and the Economic and Public Health Evaluation Committee of HAS...
December 15, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29246649/utility-of-routine-evaluation-of-sterility-of-cellular-therapy-products-with-or-without-extensive-manipulation-best-practices-and-clinical-significance
#10
Josee Golay, Olga Pedrini, Chiara Capelli, Elisa Gotti, Gianmaria Borleri, Mara Magri, Francesca Vailati, Marco Passera, Claudio Farina, Alessandro Rambaldi, Martino Introna
BACKGROUND: We analyzed the results of routine sterility testing performed in our center over the last 10 years, in the context both hematopoietic stem cell transplantation (HSCT) and Advanced Therapeutic Medicinal Products (ATMPs). METHODS: For sterility tests 14-day cultures were performed in culture media detecting aerobic and anaerobic microorganisms. RESULTS: In this study, 22/1643 (1.3%) of apheretic products for autologous or allogeneic HSCT were contaminated, whereas 14/73 bone marrow (BM) harvests (17...
December 12, 2017: Cytotherapy
https://www.readbyqxmd.com/read/29239690/antibody-drug-conjugates-design-and-development-for-therapy-and-imaging-in-and-beyond-cancer-labex-mabimprove-industrial-workshop-july-27-28-2017-tours-france
#11
Camille Martin, Claire Kizlik-Masson, André Pèlegrin, Hervé Watier, Marie-Claude Viaud-Massuard, Nicolas Joubert
The annual "Antibody Industrial Symposium", co organized by LabEx MAbImprove, MabDesign and Polepharma, was held in Tours, France on June 27-28, 2017. The focus was on antibody-drug-conjugates (ADCs), new entities which realize the hope of Paul Ehrlich's magic bullet. ADCs result from the bioconjugation of a highly cytotoxic drug to a selective monoclonal antibody, which acts as a vector. Building on knowledge gained during the development of three approved ADCs, brentuximab vedotin (Adcetris®), ado trastuzumab emtansine (Kadcyla®) and inotuzumab ozogamicin (Besponsa®), and the many ADCs in development, this meeting addressed strategies and the latest innovations in the field from fundamental research to manufacturing...
December 14, 2017: MAbs
https://www.readbyqxmd.com/read/29233555/human-neural-stem-cell-transplantation-rescues-functional-deficits-in-r6-2-and-q140-huntington-s-disease-mice
#12
Jack C Reidling, Aroa Relaño-Ginés, Sandra M Holley, Joseph Ochaba, Cindy Moore, Brian Fury, Alice Lau, Andrew H Tran, Sylvia Yeung, Delaram Salamati, Chunni Zhu, Asa Hatami, Carlos Cepeda, Joshua A Barry, Talia Kamdjou, Alvin King, Dane Coleal-Bergum, Nicholas R Franich, Frank M LaFerla, Joan S Steffan, Mathew Blurton-Jones, Charles K Meshul, Gerhard Bauer, Michael S Levine, Marie-Francoise Chesselet, Leslie M Thompson
Huntington's disease (HD) is an inherited neurodegenerative disorder with no disease-modifying treatment. Expansion of the glutamine-encoding repeat in the Huntingtin (HTT) gene causes broad effects that are a challenge for single treatment strategies. Strategies based on human stem cells offer a promising option. We evaluated efficacy of transplanting a good manufacturing practice (GMP)-grade human embryonic stem cell-derived neural stem cell (hNSC) line into striatum of HD modeled mice. In HD fragment model R6/2 mice, transplants improve motor deficits, rescue synaptic alterations, and are contacted by nerve terminals from mouse cells...
December 6, 2017: Stem Cell Reports
https://www.readbyqxmd.com/read/29222908/how-effective-are-common-household-preparations-on-removing-pesticide-residues-from-fruit-and-vegetables-a-review
#13
REVIEW
Stephen W C Chung
Nowadays, the use of pesticides is inevitable for pest-control in crops, especially the fruit and vegetables. After the harvest from raw agricultural commodities, the amount of pesticide residues in food is mainly influenced by the storage, handling and processing that follow. If good agricultural and good manufacturing practices are enforced effectively, the amount of pesticide residues would be brought below the corresponding maximum residue level. Thus, the consumption of raw and/or prepared fruit and vegetables would be safe...
December 9, 2017: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/29220861/do-we-need-plant-food-supplements-a-critical-examination-of-quality-safety-efficacy-and-necessity-for-a-new-regulatory-framework
#14
Mona Abdel-Tawab
Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs...
December 8, 2017: Planta Medica
https://www.readbyqxmd.com/read/29216613/documentation-records-and-reports
#15
Michael J Akers
This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them...
September 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/29212357/manufacture-of-third-generation-lentivirus-for-preclinical-use-with-process-development-considerations-for-translation-to-good-manufacturing-practice-gmp
#16
Carolina Gándara, Valerie Affleck, Elizabeth Ann Stoll
Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly used for clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet the manufacture of these vectors is challenging, especially at high titres required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation...
December 6, 2017: Human Gene Therapy Methods
https://www.readbyqxmd.com/read/29205456/automated-production-of-18-f-ftha-according-to-gmp
#17
Nina Savisto, Tapio Viljanen, Esa Kokkomäki, Jörgen Bergman, Olof Solin
14-(R,S)-[18 F]fluoro-6-thia-heptadecanoic acid is a tracer for fatty acid imaging by positron emission tomography. High demand for this tracer required us to replace semi-automatic synthesis with a fully automated procedure. An automated synthesis device was constructed in-house for multistep nucleophilic 18 F-fluorination and a control system was developed. The synthesis device was combined with a sterile filtration unit and both were qualified. 14-(R,S)-[18 F]fluoro-6-thia-heptadecanoic acid was produced according to good manufacturing practice guidelines set by the European Union...
December 4, 2017: Journal of Labelled Compounds & Radiopharmaceuticals
https://www.readbyqxmd.com/read/29191482/multivariate-modeling-of-diffuse-reflectance-infrared-fourier-transform-drift-spectra-of-mixtures-with-low-content-polymorphic-impurities-with-analysis-of-outliers
#18
Slobodan Šašić, Andrew Gilkison, Mark Henson
Diffuse Reflectance Fourier Transform Infrared Spectroscopy (DRIFTS)-based multivariate models were developed to quantify the content of two polymorphic impurities in mixtures with the desired active pharmaceutical ingredient (API) form, with the impurities not exceeding 2% wt/wt. In addition, close attention was paid to the outlier detection criteria: Q residuals; Hotelling T2; and score bi-plot. While reasonably accurate results were obtained for the relatively simple calibration models for both forms of the impurity, the predictions for "blank" samples (separately verified to be impurity-free) were apparently biased...
November 27, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/29173894/generation-of-off-the-shelf-natural-killer-cells-from-peripheral-blood-cell-derived-induced-pluripotent-stem-cells
#19
Jieming Zeng, Shin Yi Tang, Lai Ling Toh, Shu Wang
Current donor cell-dependent strategies can only produce limited "made-to-order" therapeutic natural killer (NK) cells for limited patients. To provide unlimited "off-the-shelf" NK cells that serve many recipients, we designed and demonstrated a holistic manufacturing scheme to mass-produce NK cells from induced pluripotent stem cells (iPSCs). Starting with a highly accessible human cell source, peripheral blood cells (PBCs), we derived a good manufacturing practice-compatible iPSC source, PBC-derived iPSCs (PBC-iPSCs) for this purpose...
November 17, 2017: Stem Cell Reports
https://www.readbyqxmd.com/read/29159905/autologous-mesenchymal-stem-cell-and-islet-cotransplantation-safety-and-efficacy
#20
Hongjun Wang, Charlie Strange, Paul J Nietert, Jingjing Wang, Taylor L Turnbull, Colleen Cloud, Stefanie Owczarski, Betsy Shuford, Tara Duke, Gary Gilkeson, Louis Luttrell, Kathie Hermayer, Jyotika Fernandes, David B Adams, Katherine A Morgan
Islet engraftment after transplantation is impaired by high rates of islet/β cell death caused by cellular stressors and poor graft vascularization. We studied whether cotransplantation of ex vivo expanded autologous bone marrow-derived mesenchymal stem cells (MSCs) with islets is safe and beneficial in chronic pancreatitis patients undergoing total pancreatectomy with islet autotransplantation. MSCs were harvested from the bone marrow of three islet autotransplantation patients and expanded at our current Good Manufacturing Practices (cGMP) facility...
January 2018: Stem Cells Translational Medicine
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