keyword
MENU ▼
Read by QxMD icon Read
search

Good manufacturing practice

keyword
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
#1
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
#2
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
#3
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 14, 2017: ACS Nano
https://www.readbyqxmd.com/read/28612694/-anticholinergic-syndrome-caused-by-contaminated-herbal-tea-acting-swiftly-to-identify-the-source
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28583200/high%C3%A2-quality-clinical%C3%A2-grade-human-embryonic-stem-cell-lines-derived-from-fresh-discarded-embryos
#10
Jinpei Ye, Nicola Bates, Despina Soteriou, Lisa Grady, Clare Edmond, Alex Ross, Alan Kerby, Philip A Lewis, Tope Adeniyi, Ronnie Wright, Kay V Poulton, Marcus Lowe, Susan J Kimber, Daniel R Brison
BACKGROUND: Human embryonic stem cells (hESCs) hold tremendous promise for cell replacement therapies for a range of degenerative diseases. In order to provide cost-effective treatments affordable by public health systems, HLA-matched allogeneic tissue banks of the highest quality clinical-grade hESCs will be required. However only a small number of existing hESC lines are suitable for clinical use; they are limited by moral and ethical concerns and none of them apply Good Manufacturing Practice (GMP) standards to the earliest and critical stages of gamete and embryo procurement...
June 5, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28579542/modeling-in-the-quality-by-design-environment-regulatory-requirements-and-recommendations-for-design-space-and-control-strategy-appointment
#11
Jelena Djuris, Zorica Djuric
Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies...
June 1, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28576333/-hygienic-sanitary-quality-in-abattoirs-from-tucuman-province-argentina-detection-isolation-and-characterization-of-shiga-toxin-producing-escherichia-coli
#12
Gabriela B Pérez Terrazzino, Marina S Condorí, Alejandro López Campo, Silvia Vega, Carolina Carbonari, Isabel Chinen, Marta Rivas, Marta C de Castillo, María A Jure
Cattle are the main reservoir of Shiga toxin-producing Escherichia coli (STEC), and the strategies to prevent the transmission of these microorganisms are concentrated in the slaughtering plant. The aim of this study was to evaluate the hygienic-sanitary quality and the frequency of detection of STEC in beef carcasses in abattoirs from Tucuman province. Two hundred and seventy four beef carcass sponges were processed; the count of generic E. coli was marginal in 9 (3,3%) of them. Escherichia coli O157 was isolated in 4 (1,4%) samples; 2 of which were characterized as stx2c(vh-a)/eae/ehxA whereas the other 2 were non-toxigenic strains...
May 30, 2017: Revista Argentina de Microbiología
https://www.readbyqxmd.com/read/28572949/consumer-knowledge-preference-and-perceived-quality-of-dried-tomato-products-in-ghana
#13
Mavis Owureku-Asare, R P Kingsly Ambrose, Ibok Oduro, Charles Tortoe, Firibu K Saalia
Postharvest losses (PHL) are incurred in the tomato value chain in Ghana and solar drying of tomato is a promising technology for reducing the loss. However, there are concerns on the usage, functionality and sensory appeal of the dried products to consumers, compounded with the lack of information and research on dried tomato processing in Ghana. A survey was carried out by administering semistructured questionnaires to 395 randomly selected and willing respondents in the Accra Metropolis. Information was obtained on the socioeconomic profile, consumption pattern, knowledge, and acceptance of tomato processing technologies and assessment of quality attributes important to consumers...
May 2017: Food Science & Nutrition
https://www.readbyqxmd.com/read/28572802/chimeric-antigen-receptor-engineered-nk-92-cells-an-off-the-shelf-cellular-therapeutic-for-targeted-elimination-of-cancer-cells-and-induction-of-protective-antitumor-immunity
#14
Congcong Zhang, Pranav Oberoi, Sarah Oelsner, Anja Waldmann, Aline Lindner, Torsten Tonn, Winfried S Wels
Significant progress has been made in recent years toward realizing the potential of natural killer (NK) cells for cancer immunotherapy. NK cells can respond rapidly to transformed and stressed cells and have the intrinsic potential to extravasate and reach their targets in almost all body tissues. In addition to donor-derived primary NK cells, also the established NK cell line NK-92 is being developed for adoptive immunotherapy, and general safety of infusion of irradiated NK-92 cells has been established in phase I clinical trials with clinical responses observed in some of the cancer patients treated...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28572733/the-jordan-food-and-drug-administration-comparison-of-its-registration-process-with-australia-canada-saudi-arabia-and-singapore
#15
Wesal Salem Al Haqaish, Hayel Obeidat, Prisha Patel, Stuart Walker
OBJECTIVE: This study outlines the current regulatory review process and good review practices (GRevPs) at the Jordan Food and Drug Administration (JFDA) and compares them with those of regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to gauge how well the JFDA is performing. We identify opportunities for further development of the JFDA as a key global reference agency. METHODS: Personnel within the JFDA completed a questionnaire comprising four sections: organisation, key milestones, review timelines, and GRevPs...
2017: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/28553737/safety-assessment-of-anthemis-nobilis-derived-ingredients-as-used-in-cosmetics
#16
Wilbur Johnson, Bart Heldreth, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, F Alan Andersen
Anthemis nobilis (Roman chamomile) flower extract, anthemis nobilis flower oil, anthemis nobilis flower powder, and anthemis nobilis flower water are ingredients that function as fragrance ingredients and skin-conditioning agents in cosmetic products. These ingredients are being used at concentrations up to 10% (anthemis nobilis flower water) in cosmetic products. The available data indicate that these 4 ingredients are not irritating or sensitizing. Chemical composition data and the low use concentrations suggest that systemic toxicity would not be likely if percutaneous absorption of constituents were to occur...
May 2017: International Journal of Toxicology
https://www.readbyqxmd.com/read/28552229/strategies-for-bringing-stem-cell-derived-dopamine-neurons-to-the-clinic-the-nystem-trial
#17
Lorenz Studer
Over the last 10 years, there has been significant progress in defining culture conditions to derive bona fide human midbrain dopamine (mDA) neurons from human embryonic stem cells or from human-induced pluripotent stem cells, two cell sources referred to as human pluripotent stem cells (hPSCs). Those developments have made it possible to manufacture mDA neurons with at sufficient scale and precision to contemplate their use in cell replacement therapy for the treatment of Parkinson's disease. Our group is one of the several teams that are in the process of initiating the first human clinical trials based on the use of mDA neurons derived from hPSCs...
2017: Progress in Brain Research
https://www.readbyqxmd.com/read/28552226/preparation-characterization-and-banking-of-clinical-grade-cells-for-neural-transplantation-scale-up-fingerprinting-and-genomic-stability-of-stem-cell-lines
#18
Ammar Natalwala, Tilo Kunath
Parkinson's disease is a complex and progressive neurodegenerative condition that is characterized by the severe loss of midbrain dopaminergic (mDA) neurons, which innervate the striatum. Cell transplantation therapies to rebuild this dopaminergic network have been attempted for over 30 years. The most promising outcomes were observed when human fetal mesencephalic tissue was used as the source of cells for transplantation. However, reliance on terminations for a Parkinson's therapy presents significant logistical and ethical hurdles...
2017: Progress in Brain Research
https://www.readbyqxmd.com/read/28544662/tracheal-replacement-therapy-with-a-stem-cell-seeded-graft-lessons-from-compassionate-use-application-of-a-gmp-compliant-tissue-engineered-medicine
#19
Martin J Elliott, Colin R Butler, Aikaterini Varanou-Jenkins, Leanne Partington, Carla Carvalho, Edward Samuel, Claire Crowley, Peggy Lange, Nicholas J Hamilton, Robert E Hynds, Tahera Ansari, Paul Sibbons, Anja Fierens, Claire McLaren, Derek Roebuck, Colin Wallis, Nagarajan Muthialu, Richard Hewitt, David Crabbe, Sam M Janes, Paolo De Coppi, Mark W Lowdell, Martin A Birchall
Tracheal replacement for the treatment of end-stage airway disease remains an elusive goal. The use of tissue-engineered tracheae in compassionate use cases suggests that such an approach is a viable option. Here, a stem cell-seeded, decellularized tissue-engineered tracheal graft was used on a compassionate basis for a girl with critical tracheal stenosis after conventional reconstructive techniques failed. The graft represents the first cell-seeded tracheal graft manufactured to full good manufacturing practice (GMP) standards...
June 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28535421/differentiation-of-crataegus-spp-guided-by-nuclear-magnetic-resonance-spectrometry-with-chemometric-analyses
#20
Jensen A Lund, Paula N Brown, Paul R Shipley
For compliance with US Current Good Manufacturing Practice regulations for dietary supplements, manufacturers must provide identity of source plant material. Despite the popularity of hawthorn as a dietary supplement, relatively little is known about the comparative phytochemistry of different hawthorn species, and in particular North American hawthorns. The combination of NMR spectrometry with chemometric analyses offers an innovative approach to differentiating hawthorn species and exploring the phytochemistry...
May 20, 2017: Phytochemistry
keyword
keyword
82749
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"