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https://www.readbyqxmd.com/read/28726923/robust-manufacturing-of-lipid-polymer-nanoparticles-through-feedback-control-of-parallelized-swirling-microvortices
#1
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)...
July 20, 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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/28673774/development-functional-characterization-and-validation-of-methodology-for-gmp-compliant-manufacture-of-phagocytic-macrophages-a-novel-cellular-therapeutic-for-liver-cirrhosis
#8
Alasdair R Fraser, Chloe Pass, Paul Burgoyne, Anne Atkinson, Laura Bailey, Audrey Laurie, Neil W A McGowan, Akib Hamid, Joanna K Moore, Benjamin J Dwyer, Marc L Turner, Stuart J Forbes, John D M Campbell
BACKGROUND AIMS: Autologous macrophage therapy represents a potentially significant therapeutic advance for the treatment of severe progressive liver cirrhosis. Administration of macrophages has been shown to reduce inflammation and drive fibrotic scar breakdown and tissue repair in relevant models. This therapeutic approach is being assessed for safety and feasibility in a first-in-human trial (MAcrophages Therapy for liver CirrHosis [MATCH] trial). METHODS: We outline the development and validation phases of GMP production...
June 30, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28672823/simultaneous-calibration-a-joint-optimization-approach-for-multiple-kinect-and-external-cameras
#9
Yajie Liao, Ying Sun, Gongfa Li, Jianyi Kong, Guozhang Jiang, Du Jiang, Haibin Cai, Zhaojie Ju, Hui Yu, Honghai Liu
Camera calibration is a crucial problem in many applications, such as 3D reconstruction, structure from motion, object tracking and face alignment. Numerous methods have been proposed to solve the above problem with good performance in the last few decades. However, few methods are targeted at joint calibration of multi-sensors (more than four devices), which normally is a practical issue in the real-time systems. In this paper, we propose a novel method and a corresponding workflow framework to simultaneously calibrate relative poses of a Kinect and three external cameras...
June 24, 2017: Sensors
https://www.readbyqxmd.com/read/28651055/pharmacokinetic-characterization-of-18-f-ucb-h-pet-radiopharmaceutical-in-the-rat-brain
#10
Guillaume Becker, Corentin Warnier, Maria Elisa Serrano, Mohamed Ali Bahri, Joël Mercier, Christian Lemaire, Eric Salmon, André Luxen, Alain Plenevaux
The synaptic vesicle glycoprotein 2A (SV2A), a protein essential to the proper nervous system function, is found in presynaptic vesicles. Thus, SV2A targeting, using dedicated radiotracers combined with positron emission tomography (PET), allows the assessment of synaptic density in the living brain. The first-in-class fluorinated SV2A specific radioligand, [(18)F]UCB-H, is now available at high-activity through an efficient radiosynthesis compliant with the current good manufacturing practices (cGMP). We report here a non-invasive method to quantify [(18)F]UCB-H binding in rat brain with microPET...
June 26, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28648818/evaluation-of-the-preimplantation-worksheet-in-determining-calypso-eligibility-for-men-prescribed-postprostatectomy-radiotherapy-with-electromagnetic-transponder-guidance
#11
Daniel George Hamilton, Kingsley Jones, Kevin So
This study aimed to assess the design and performance of the preimplant suitability worksheet in determining Calypso eligibility for prostate cancer patients prescribed postprostatectomy radiotherapy with electromagnetic transponder guidance. The medical records and radiotherapy planning datasets of 75 patients prospectively recruited between June 2015 and September 2016 to a Phase 2 trial evaluating electromagnetic transponder-guided postprostatectomy radiotherapy were retrospectively examined. Correlation and differences between computed tomography (CT)-defined greater trochanter and prostatic fossa landmarks were evaluated...
June 22, 2017: Medical Dosimetry: Official Journal of the American Association of Medical Dosimetrists
https://www.readbyqxmd.com/read/28622644/study-on-the-occurrence-of-polycyclic-aromatic-hydrocarbons-in-milk-and-meat-fish-based-baby-food-available-in-italy
#12
Serena Santonicola, Stefania Albrizio, Nicoletta Murru, Maria Carmela Ferrante, Raffaelina Mercogliano
The study compared the profile of 14 polycyclic aromatic hydrocarbons, frequently occurred in food, in milk (N = 22) and meat/fish based (N = 18) baby foods available on the Italian market. PAH total levels, markers (Regulation EC/835/2011) and carcinogenic PAHs were determined by high- performance liquid chromatography with fluorescence detector (HPLC-FD). The average of total PAHs was 52.25 μg kg(-1) in milk and 11.82 μg kg(-1) in meat/fish based baby foods. The levels of PAH markers were higher than the permissible EU limits of 1 μg kg(-1) in 18...
June 6, 2017: Chemosphere
https://www.readbyqxmd.com/read/28619938/kilogram-scale-prexasertib-monolactate-monohydrate-synthesis-under-continuous-flow-cgmp-conditions
#13
Kevin P Cole, Jennifer McClary Groh, Martin D Johnson, Christopher L Burcham, Bradley M Campbell, William D Diseroad, Michael R Heller, John R Howell, Neil J Kallman, Thomas M Koenig, Scott A May, Richard D Miller, David Mitchell, David P Myers, Steven S Myers, Joseph L Phillips, Christopher S Polster, Timothy D White, Jim Cashman, Declan Hurley, Robert Moylan, Paul Sheehan, Richard D Spencer, Kenneth Desmond, Paul Desmond, Olivia Gowran
Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods...
June 16, 2017: Science
https://www.readbyqxmd.com/read/28613076/metal-organic-framework-derived-nanoporous-metal-oxides-toward-supercapacitor-applications-progress-and-prospects
#14
Rahul R Salunkhe, Yusuf V Kaneti, Yusuke Yamauchi
Transition metal oxides (TMOs) have attracted significant attention for energy storage applications such as supercapacitors due to their good electrical conductivity, high electrochemical response (by providing Faradaic reactions), low manufacturing costs, and easy processability. Despite exhibiting these attractive characteristics, the practical applications of TMOs for supercapacitors are still relatively limited. This is largely due to their continuous Faradaic reactions, which can lead to major changes or destruction of their structure as well phase changes (in some cases) during cycling, leading to the degradation in their capacitive performance over time...
June 27, 2017: ACS Nano
https://www.readbyqxmd.com/read/28612694/-anticholinergic-syndrome-caused-by-contaminated-herbal-tea-acting-swiftly-to-identify-the-source
#15
C Oerlemans, I de Vries, A J H P van Riel
BACKGROUND: Despite good manufacturing practice and quality control, consumer products can become contaminated. In some cases, this can result in severe and life-threatening intoxication with potentially fatal consequences. CASE DESCRIPTION: A 27-year-old man and a 28-year-old pregnant woman presented to the Emergency Department with severe anticholinergic syndrome after using a marshmallow root (Althaea officinalis) herbal remedy, mixed into hot chocolate drink, to reduce symptoms of common cold...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28610481/efficacy-of-humanized-mesenchymal-stem-cell-cultures-for-bone-tissue-engineering-a-systematic-review-with-a-focus-on-platelet-derivatives
#16
Siddharth Shanbhag, Andreas Stavropoulos, Salwa Suliman, Tor Hervig, Kamal Mustafa
Fetal bovine serum (FBS) is the most commonly used supplement for ex vivo expansion of human mesenchymal stem cells (hMSCs) for bone tissue engineering applications. However, from a clinical standpoint, it is important to substitute animal-derived products according to current Good Manufacturing Practice (cGMP) guidelines. Humanized alternatives to FBS include three categories of products: human serum (HS), human platelet-derivatives (HPD) - including platelet lysate (PL) or releasate (PR), produced by freeze-/thawing or chemical activation of platelet concentrates, respectively; and chemically-defined media (CDM)...
June 13, 2017: Tissue Engineering. Part B, Reviews
https://www.readbyqxmd.com/read/28604318/complementary-medicines-when-regulation-results-in-revolution
#17
Liezl Fourie, Frasia Oosthuizen, Karen Du Toit
Medicines have evolved over time and so has the realisation of the importance of quality control and regulatory processes. The regulatory practices include all the steps from the development and manufacture of the active ingredients until the medicines reach the consumer. The Medicines Control Council (MCC) is mandated to regulate medicines in South Africa. Complementary medicines were previously perceived to be unregulated, although the Medicines Act does not distinguish between allopathic and complementary medicine...
May 24, 2017: South African Medical Journal, Suid-Afrikaanse Tydskrif Vir Geneeskunde
https://www.readbyqxmd.com/read/28604060/current-trends-and-perspectives-of-bioactive-peptides
#18
Eric Banan-Mwine Daliri, Byong H Lee, Deog H Oh
The remarkable growth of therapeutic peptide development in the past decade has led to a large number of market approvals and the market value is expected to hit $25 billion by 2018. This significant market increase is driven by the increasing incidences of metabolic and cardiovascular diseases and technological advancements in peptide synthesis. For this reason, the search for bioactive peptides has also increased exponentially. Many bioactive peptides from food and nonfood sources have shown positive health effects yet, obstacles such as the need to implement efficient and cost-effective strategies for industrial scale production, good manufacturing practices as well as well-designed clinical trials to provide robust evidence for supporting health claims continue to exist...
June 12, 2017: Critical Reviews in Food Science and Nutrition
https://www.readbyqxmd.com/read/28599073/a-monte-carlo-model-and-its-commissioning-for-the-leksell-gamma-knife-perfexion-radiosurgery-system
#19
Jiankui Yuan, Mitchell Machtay
PURPOSE: To develop and commission a Monte Carlo (MC) simulation model for the Leksell Gamma Knife (LGK) Perfexion (PFX) radiosurgery system. METHOD: We previously established a source model for MC simulations of the LGK PFX for the purpose of the treatment planning system (TPS) dose verification and plan evaluation. To make practical and effective use of the model in clinic, several issues need to be addressed. First, thorough commissioning procedures are needed to ensure the validity of the model parameters, such as the source-to-focus (STF) distance, the source solid angle...
June 9, 2017: Medical Physics
https://www.readbyqxmd.com/read/28585863/contamination-of-carcasses-and-utensils-in-small-swine-slaughterhouses-by-salmonella-in-the-northwestern-region-of-the-state-of-rio-de-janeiro-brazil
#20
Claudius Couto Cabral, Pedro Henrique Nunes Panzenhagen, Karina Frensel Delgado, Gabriela Rodrigues Alves Silva, Dália Dos Prazeres Rodrigues, Robson Maia Franco, Carlos Adam Conte-Junior
Salmonella is a major foodborne pathogen that constantly threatens food safety in developed countries and underdeveloped countries such as Brazil, where it is responsible for 38% of notified cases of foodborne illness. Swine are one of the main meat-producing species that may asymptomatically carry Salmonella, periodically shedding the bacteria through feces. The state of Rio de Janeiro is not a major producer of swine meat, but small slaughterhouses are operational and produce meat for consumption within the state, although few studies have been conducted in the region...
June 6, 2017: Journal of Food Protection
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