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Microbial pharmaceutical quality

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https://www.readbyqxmd.com/read/28710854/opportunities-and-challenges-of-real-time-release-testing-in-biopharmaceutical-manufacturing
#1
REVIEW
Mo Jiang, Kristen Severson, J Christopher Love, Helena Madden, Patrick Swann, Li Zang, Richard D Braatz
Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8(R2)). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products...
July 15, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28613926/cold-atmospheric-plasma-manipulation-of-proteins-in-food-systems
#2
Haniye Tolouie, Maryam Hashemi, Mohammad Amin Mohammadifar, Hamid Ghomi
Plasma processing has been getting a lot of attention in recent applications as a novel, eco-friendly, and highly efficient approach. Cold plasma has mostly been used to reduce microbial counts in foodstuff and biological materials, as well as in different levels of packaging, particularly in cases where there is thermal sensitivity. As it is a very recent application, the impact of cold plasma treatment has been studied on the protein structures of food and pharmaceutical systems, as well as in the packaging industry...
June 14, 2017: Critical Reviews in Food Science and Nutrition
https://www.readbyqxmd.com/read/28523956/pathogen-reduction-technologies-the-pros-and-cons-for-platelet-transfusion
#3
Audrey Magron, Jonathan Laugier, Patrick Provost, Eric Boilard
The transfusion of platelets is essential for diverse pathological conditions associated with thrombocytopenia or platelet disorders. To maintain optimal platelet quality and functions, platelets are stored as platelet concentrates (PCs) at room temperature under continuous agitation-conditions that are permissive for microbial proliferation. In order to reduce these contaminants, pathogen reduction technologies (PRTs) were developed by the pharmaceutical industry and subsequently implemented by blood banks...
May 19, 2017: Platelets
https://www.readbyqxmd.com/read/28285374/antibiotic-mixture-effects-on-growth-of-the-leaf-shredding-stream-detritivore-gammarus-fossarum
#4
Mirco Bundschuh, Torsten Hahn, Mark O Gessner, Ralf Schulz
Pharmaceuticals contribute greatly to human and animal health. Given their specific biological targets, pharmaceuticals pose a significant environmental risk by affecting organisms and ecosystem processes, including leaf-litter decomposition. Although litter decomposition is a central process in forest streams, the consequences of exposure to pharmaceuticals remain poorly known. The present study assessed the impact of antibiotics as an important class of pharmaceuticals on the growth of the leaf-shredding amphipod Gammarus fossarum over 24 days...
May 2017: Ecotoxicology
https://www.readbyqxmd.com/read/28040193/the-importance-of-quality-control-in-validating-concentrations-of-contaminants-of-emerging-concern-in-source-and-treated-drinking-water-samples
#5
Angela L Batt, Edward T Furlong, Heath E Mash, Susan T Glassmeyer, Dana W Kolpin
A national-scale survey of 247 contaminants of emerging concern (CECs), including organic and inorganic chemical compounds, and microbial contaminants, was conducted in source and treated drinking water samples from 25 treatment plants across the United States. Multiple methods were used to determine these CECs, including six analytical methods to measure 174 pharmaceuticals, personal care products, and pesticides. A three-component quality assurance/quality control (QA/QC) program was designed for the subset of 174 CECs which allowed us to assess and compare performances of the methods used...
February 1, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28028873/development-of-a-qualitative-real-time-pcr-for-microbiological-quality-control-testing-in-mammalian-cell-culture-production
#6
K Kleinschmidt, E Wilkens, S P Glaeser, P Kaempfer, A Staerk, D Roesti
AIMS: The aim of this study was to develop and evaluate a real-time PCR technology for microbiological control methods to examine individualized cell therapeutics, an emerging class of pharmaceutical formulations. METHODS AND RESULTS: Oligonucleotide primers and hybridization probe for bacterial detection targeting the 16SrRNA gene were adapted based on Nadkarni et al. [Microbiology148 (2002) 257]. For detection of yeast and moulds, primers and probe were designed from conserved sequences of the 18SrRNA gene in this study...
April 2017: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/28003627/validation-study-and-quality-assurance-of-pharmaceutical-water-waterborne-microorganisms-and-endotoxins
#7
REVIEW
Hideharu Shintani
 Water for injection (WFI) and purified water are the most widely used and stringently regulated raw material in pharmaceutical manufacturing. WFI is utilized for a parenteral drug product. Water system is monitored at frequent and routine frequency for demonstrating the overall system control and stability of performance. The critical ports demonstrating systemic control should be monitored more frequently. For reducing the overall risk of microbial contamination or microbial build-up, it is important to develop appropriate alert and action levels...
2016: Biocontrol Science
https://www.readbyqxmd.com/read/27974628/quantitative-microbial-risk-assessment-of-pharmaceutical-products
#8
Mostafa Essam Eissa
Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice and efficient control on bioburden level of product components are critical parameters that influence the microbiological cleanliness of medicinal products. However, because microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases...
May 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27803696/new-weapons-to-fight-old-enemies-novel-strategies-for-the-bio-control-of-bacterial-biofilms-in-the-food-industry
#9
REVIEW
Laura M Coughlan, Paul D Cotter, Colin Hill, Avelino Alvarez-Ordóñez
Biofilms are microbial communities characterized by their adhesion to solid surfaces and the production of a matrix of exopolymeric substances, consisting of polysaccharides, proteins, DNA and lipids, which surround the microorganisms lending structural integrity and a unique biochemical profile to the biofilm. Biofilm formation enhances the ability of the producer/s to persist in a given environment. Pathogenic and spoilage bacterial species capable of forming biofilms are a significant problem for the healthcare and food industries, as their biofilm-forming ability protects them from common cleaning processes and allows them to remain in the environment post-sanitation...
2016: Frontiers in Microbiology
https://www.readbyqxmd.com/read/27789803/container-closure-integrity-testing-practical-aspects-and-approaches-in-the-pharmaceutical-industry
#10
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for Quality Control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27778222/strategies-for-efficient-and-economical-2-3-butanediol-production-new-trends-in-this-field
#11
REVIEW
Aneta M Białkowska
2,3-Butanediol (2,3-BD) is a promising bulk chemical with a potentially wide range of applications e.g., in the manufacture of printing inks, perfumes, synthetic rubber, fumigants, antifreeze agents, fuel additives, foodstuffs and pharmaceuticals. Its high heating value and ability to increase the octane number of fuels make 2,3-BD a promising drop-in fuel. It can also be converted to methyl-ethyl ketone (MEK), which is considered an effective liquid fuel additive. After combination with MEK and hydrogenation reaction, 2,3-BD can be converted to octane, which is used to produce high-quality aviation fuel...
December 2016: World Journal of Microbiology & Biotechnology
https://www.readbyqxmd.com/read/27766214/an-overview-on-novel-microbial-determination-methods-in-pharmaceutical-and-food-quality-control
#12
Mahboob Nemati, Aliasghar Hamidi, Solmaz Maleki Dizaj, Vahid Javaherzadeh, Farzaneh Lotfipour
Traditional microbiological methods tend to be labor-intensive and time-consuming. Rapid and novel methods in microbiological tests provide more sensitive, precise and reproducible results compared with conventional methods. In microbiology, the most rapid testing methods belong to the field of biotechnology such as PCR, ELISA, ATP bioluminescence and etc. Nevertheless impedance microbiology, biosensors and analytical procedures to determine microbial constituents are of significance. The present review article was conducted using internet databases and related scientific literatures and articles that provide information on developments in the rapid methods in microbiology...
September 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/27688016/probiotics-for-the-prevention-of-pediatric-antibiotic-associated-diarrhea
#13
COMMENT
Shelby R Hayes, Ashley J Vargas
Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea.Cochrane Database Syst Rev2015, Issue 12. Art. No.: CD004827. http://dx.doi.org/10.1002/14651858.CD004827.pub4. BACKGROUND: Antibiotics are frequently prescribed in children. They alter the microbial balance within the gastrointestinal tract, commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via restoration of the gut microflora...
November 2016: Explore: the Journal of Science and Healing
https://www.readbyqxmd.com/read/27535403/value-added-product-recovery-from-sludge-generated-during-gum-arabic-refining-process-by-vermicomposting
#14
Veena Das, Sanjeev Satyanarayan, Shanta Satyanarayan
Gum arabic is multifunctional and used in food products, pharmaceutical, confectionery, cosmetic, printing and textile industry. Gum arabic has an excellent market and its production is being increased to meet the market demand. In the process, huge quantity of solid waste is generated during its refining process. An attempt has been made to vermicompost this organic waste using Eudrilus eugeniae. This research work is first of its kind. Literature on this substrate has not been reported anywhere else for vermicomposting...
September 2016: Environmental Monitoring and Assessment
https://www.readbyqxmd.com/read/27350424/validation-study-of-rapid-assays-of-bioburden-endotoxins-and-other-contamination
#15
REVIEW
Hideharu Shintani
Microbial testing performed in support of pharmaceutical and biopharmaceutical production falls into three main categories: detection (qualitative), enumeration (quantitative), and characterization/identification. Traditional microbiological methods are listed in the compendia and discussed by using the conventional growth-based techniques, which are labor intensive and time consuming. In general, such tests require several days of incubation for microbial contamination (bioburden) to be detected, and therefore management seldom is able to take proactive corrective measures...
2016: Biocontrol Science
https://www.readbyqxmd.com/read/27322241/a-review-of-the-latest-advances-in-encrypted-bioactive-peptides-from-protein-rich-waste
#16
REVIEW
Ailton Cesar Lemes, Luisa Sala, Joana da Costa Ores, Anna Rafaela Cavalcante Braga, Mariana Buranelo Egea, Kátia Flávia Fernandes
Bioactive peptides are considered the new generation of biologically active regulators that not only prevent the mechanism of oxidation and microbial degradation in foods but also enhanced the treatment of various diseases and disorders, thus increasing quality of life. This review article emphasizes recent advances in bioactive peptide technology, such as: (i) new strategies for transforming bioactive peptides from residual waste into added-value products; (ii) nanotechnology for the encapsulation, protection and release of controlled peptides; and (iii) use of techniques of large-scale recovery and purification of peptides aiming at future applications to pharmaceutical and food industries...
June 16, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/27317164/links-between-the-microbiome-and-bone
#17
Christopher J Hernandez, Jason D Guss, Marysol Luna, Steven R Goldring
The human microbiome has been shown to influence a number of chronic conditions associated with impaired bone mass and bone quality, including obesity, diabetes, and inflammatory bowel disease. The connection between the microbiome and bone health, however, has not been well studied. The few studies available demonstrate that the microbiome can have a large effect on bone remodeling and bone mass. The gut microbiome is the largest reservoir of microbial organisms in the body and consists of more than a thousand different species interacting with one another in a stable, dynamic equilibrium...
September 2016: Journal of Bone and Mineral Research: the Official Journal of the American Society for Bone and Mineral Research
https://www.readbyqxmd.com/read/27312276/septic-systems-as-hot-spots-of-pollutants-in-the-environment-fate-and-mass-balance-of-micropollutants-in-septic-drainfields
#18
Yun-Ya Yang, Gurpal S Toor, P Chris Wilson, Clinton F Williams
Septic systems, a common type of onsite wastewater treatment systems, can be an important source of micropollutants in the environment. We investigated the fate and mass balance of 17 micropollutants, including wastewater markers, hormones, pharmaceuticals and personal care products (PPCPs) in the drainfield of a septic system. Drainfields were replicated in lysimeters (1.5m length, 0.9m width, 0.9m height) and managed similar to the field practice. In each lysimeter, a drip line dispersed 9L of septic tank effluent (STE) per day (equivalent to 32...
October 1, 2016: Science of the Total Environment
https://www.readbyqxmd.com/read/27208663/a-new-method-for-long-term-storage-of-titred-microbial-standard-solutions-suitable-for-microbiologic-quality-control-activities-of-pharmaceutical-companies
#19
Carolina Chiellini, Stefano Mocali, Renato Fani, Iolanda Ferro, Serenella Bruschi, Alessandro Pinzani
No abstract text is available yet for this article.
August 2016: Journal of Microbiological Methods
https://www.readbyqxmd.com/read/26954177/quality-and-acceptability-of-meat-nuggets-with-fresh-aloe-vera-gel
#20
V Rajkumar, Arun K Verma, G Patra, S Pradhan, S Biswas, P Chauhan, Arun K Das
Aloe vera has been used worldwide for pharmaceutical, food, and cosmetic industries due to its wide biological activities. However, quality improvement of low fat meat products and their acceptability with added Aloe vera gel (AVG) is scanty. The aim of this study was to explore the feasibility of using fresh AVG on physicochemical, textural, sensory and nutritive qualities of goat meat nuggets. The products were prepared with 0%, 2.5%, and 5% fresh AVG replacing goat meat and were analyzed for proximate composition, physicochemical and textural properties, fatty acid profile and sensory parameters...
May 2016: Asian-Australasian Journal of Animal Sciences
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