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https://www.readbyqxmd.com/read/28227155/teaching-biomedical-design-through-a-university-industry-partnership
#1
Lunal Khuon, Karl R Zum, Jane B Zurn, Gerald M Herrera, Lunal Khuon, Karl R Zum, Jane B Zurn, Gerald M Herrera, Gerald M Herrera, Karl R Zurn, Lunal Khuon
This paper describes a course that, as a result of a university-industry partnership, emphasizes bringing industry experts into the classroom to teach biomedical design. Full-time faculty and industry engineers and entrepreneurs teach the senior technical elective course, Biomedical System Design. This hands-on senior course in biomedical system design places varied but connected emphasis on understanding the biological signal source, electronics design, safety, patient use, medical device qualifications, and good manufacturing practices...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28221926/evaluation-of-selected-nutrients-and-contaminants-in-distillers-grains-from-ethanol-production-in-texas
#2
Kyung-Min Lee, Timothy J Herrman, Lynn Post
This article contains the results of the evaluation of distillers grain (DG) coproducts from different ethanol plants around the United States and supplemented in animal diets in Texas, based on samples analyzed from 2008 to 2014. The samples were assessed for concentration, occurrence, and prevalence of selected nutrients and contaminants. Protein and sulfur contents of DG were largely different between maize and sorghum coproducts, as well as wet distillers grain with solubles (WDGS) and dried distillers grain with solubles (DDGS), indicating a significant effect of grain feedstock and dry grind process stream on DG composition and quality...
September 2016: Journal of Food Protection
https://www.readbyqxmd.com/read/28221723/animal-component-free-agrobacterium-tumefaciens-cultivation-media-for-better-gmp-compliance-increases-biomass-yield-and-pharmaceutical-protein-expression-in-nicotiana-benthamiana
#3
Marcel Houdelet, Anna Galinski, Tanja Holland, Kathrin Wenzel, Stefan Schillberg, Johannes Felix Buyel
Transient expression systems allow the rapid production of recombinant proteins in plants. Such systems can be scaled up to several hundred kilograms of biomass, making them suitable for the production of pharmaceutical proteins required at short notice, such as emergency vaccines. However, large-scale transient expression requires the production of recombinant Agrobacterium tumefaciens strains with the capacity for efficient gene transfer to plant cells. The complex media often used for the cultivation of this species typically include animal-derived ingredients that can contain human pathogens, thus conflicting with the requirements of good manufacturing practice (GMP)...
February 21, 2017: Biotechnology Journal
https://www.readbyqxmd.com/read/28218731/a-single-use-in-vitro-biosensor-for-the-detection-of-t-tau-protein-a-biomarker-of-neuro-degenerative-disorders-in-pbs-and-human-serum-using-differential-pulse-voltammetry-dpv
#4
Yifan Dai, Alireza Molazemhosseini, Chung Chiun Liu
A single-use, in vitro biosensor for the detection of T-Tau protein in phosphate-buffer saline (PBS) and undiluted human serum was designed, manufactured, and tested. Differential pulse voltammetry (DPV) served as the transduction mechanism. This biosensor consisted of three electrodes: working, counter, and reference electrodes fabricated on a PET sheet. Both working and counter electrodes were thin gold film, 10 nm in thickness. Laser ablation technique was used to define the size and structure of the biosensor...
February 19, 2017: Biosensors
https://www.readbyqxmd.com/read/28208578/role-of-cortico-cancellous-heterologous-bone-in-human-periodontal-ligament-stem-cell-xeno-free-culture-studied-by-synchrotron-radiation-phase-contrast-microtomography
#5
Serena Mazzoni, Sara Mohammadi, Giuliana Tromba, Francesca Diomede, Adriano Piattelli, Oriana Trubiani, Alessandra Giuliani
This study was designed to quantitatively demonstrate via three-dimensional (3D) images, through the Synchrotron Radiation Phase-Contrast Microtomography (SR-PhC-MicroCT), the osteoinductive properties of a cortico-cancellous scaffold (Osteobiol Dual Block-DB) cultured with human Periodontal Ligament Stem Cells (hPDLSCs) in xeno-free media. In vitro cultures of hPDLSCs, obtained from alveolar crest and horizontal fibers of the periodontal ligament, were seeded onto DB scaffolds and cultured in xeno-free media for three weeks...
February 10, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28196929/pda-points-to-consider-technical-product-lifecycle-management-pharmaceutical-quality-system-effectiveness-for-managing-post-approval-changes
#6
Emma Ramnarine, Ursula Busse, Franck Chassant, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1)...
February 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28193263/automated-freeze-thaw-cycles-for-decellularization-of-tendon-tissue-a-pilot-study
#7
Susanne Pauline Roth, Sina Marie Glauche, Amelie Plenge, Ina Erbe, Sandra Heller, Janina Burk
BACKGROUND: Decellularization of tendon tissue plays a pivotal role in current tissue engineering approaches for in vitro research as well as for translation of graft-based tendon restoration into clinics. Automation of essential decellularization steps like freeze-thawing is crucial for the development of more standardized decellularization protocols and commercial graft production under good manufacturing practice (GMP) conditions in the future. METHODS: In this study, a liquid nitrogen-based controlled rate freezer was utilized for automation of repeated freeze-thawing for decellularization of equine superficial digital flexor tendons...
February 14, 2017: BMC Biotechnology
https://www.readbyqxmd.com/read/28192278/lightweight-3d-cellular-composites-inspired-by-balsa
#8
Sardar Malek, Jordan Raney, Jennifer Lewis, Lorna Gibson
Additive manufacturing technologies offer new ways to fabricate cellular materials with composite cell walls, mimicking the structure and mechanical properties of woods. However, materials limitations and a lack of design tools have confined the usefulness of 3D printed cellular materials. We develop new carbon fiber reinforced, epoxy inks for 3D printing which result in printed materials with longitudinal Young's modulus up to 57 GPa (exceeding the longitudinal modulus of wood cell wall material). To guide the design of hierarchical cellular materials, we developed a parameterized, multi-scale, finite element model...
February 13, 2017: Bioinspiration & Biomimetics
https://www.readbyqxmd.com/read/28191758/preclinical-analysis-of-fetal-human-mesencephalic-neural-progenitor-cell-lines-characterization-and-safety-in-vitro-and-in-vivo
#9
Jisook Moon, Sigrid C Schwarz, Hyun-Seob Lee, Jun Mo Kang, Young-Eun Lee, Bona Kim, Mi-Young Sung, Günter Höglinger, Florian Wegner, Jin Su Kim, Hyung-Min Chung, Sung Woon Chang, Kwang Yul Cha, Kwang-Soo Kim, Johannes Schwarz
We have developed a good manufacturing practice for long-term cultivation of fetal human midbrain-derived neural progenitor cells. The generation of human dopaminergic neurons may serve as a tool of either restorative cell therapies or cellular models, particularly as a reference for phenotyping region-specific human neural stem cell lines such as human embryonic stem cells and human inducible pluripotent stem cells. We cultivated 3 different midbrain neural progenitor lines at 10, 12, and 14 weeks of gestation for more than a year and characterized them in great detail, as well as in comparison with Lund mesencephalic cells...
February 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28188071/a-good-manufacturing-practice-grade-standard-protocol-for-exclusively-human-mesenchymal-stromal-cell-derived-extracellular-vesicles
#10
Karin Pachler, Thomas Lener, Doris Streif, Zsuzsanna A Dunai, Alexandre Desgeorges, Martina Feichtner, Michaela Öller, Katharina Schallmoser, Eva Rohde, Mario Gimona
BACKGROUND AIMS: Extracellular vesicles (EVs) released by mesenchymal stromal cells (MSCs) may contribute to biological processes such as tissue regeneration, immunomodulation and neuroprotection. Evaluation of their therapeutic potential and application in future clinical trials demands thorough characterization of EV content and production under defined medium conditions, devoid of xenogenic substances and serum-derived vesicles. Addressing the apparent need for such a growth medium, we have developed a medium formulation based on pooled human platelet lysate (pHPL), free from animal-derived xenogenic additives and depleted of EVs...
February 7, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28187777/gmp-conformant-on-site-manufacturing-of-a-cd133-stem-cell-product-for-cardiovascular-regeneration
#11
Anna Skorska, Paula Müller, Ralf Gaebel, Jana Große, Heiko Lemcke, Cornelia A Lux, Manuela Bastian, Frauke Hausburg, Nicole Zarniko, Sandra Bubritzki, Ulrike Ruch, Gudrun Tiedemann, Robert David, Gustav Steinhoff
BACKGROUND: CD133(+) stem cells represent a promising subpopulation for innovative cell-based therapies in cardiovascular regeneration. Several clinical trials have shown remarkable beneficial effects following their intramyocardial transplantation. Yet, the purification of CD133(+) stem cells is typically performed in centralized clean room facilities using semi-automatic manufacturing processes based on magnetic cell sorting (MACS®). However, this requires time-consuming and cost-intensive logistics...
February 10, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28185305/cgmp-production-of-the-radiopharmaceutical-18-f-mk-6240-for-pet-imaging-of-human-neurofibrillary-tangles
#12
Thomas Lee Collier, Daniel L Yokell, Eli Livni, Peter A Rice, Sofie Celen, Kim Serdons, Ramesh Neelamegam, Guy Bormans, Dawn Harris, Abbas Walji, Eric D Hostetler, Idriss Bennacef, Neil Vasdev
Fluorine-18 labelled 6-(fluoro)-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine ([(18) F]MK-6240) is a novel potent and selective PET radiopharmaceutical for detecting human neurofibrillary tangles, which are made up of aggregated tau protein. Herein, we report the fully automated two-step radiosynthesis of [(18) F]MK-6240 using a commercially available radiosynthesis module, GE Healthcare Tracerlab(TM) FXFN . Nucleophilic fluorination of the 5-diBoc-6-nitro precursor with potassium cryptand [(18) F]fluoride (K[(18) F]/K222 ) was carried out by conventional heating, followed by acid deprotection and semi-preparative HPLC under isocratic conditions...
February 9, 2017: Journal of Labelled Compounds & Radiopharmaceuticals
https://www.readbyqxmd.com/read/28181555/determination-of-biological-activity-of-gonadotropins-hcg-and-fsh-by-f%C3%A3-rster-resonance-energy-transfer-based-biosensors
#13
Olga Mazina, Anni Allikalt, Juha S Tapanainen, Andres Salumets, Ago Rinken
Determination of biological activity of gonadotropin hormones is essential in reproductive medicine and pharmaceutical manufacturing of the hormonal preparations. The aim of the study was to adopt a G-protein coupled receptor (GPCR)-mediated signal transduction pathway based assay for quantification of biological activity of gonadotropins. We focussed on studying human chorionic gonadotropin (hCG) and follicle-stimulating hormone (FSH), as these hormones are widely used in clinical practice. Receptor-specific changes in cellular cyclic adenosine monophosphate (cAMP, second messenger in GPCR signalling) were monitored by a Förster resonance energy transfer (FRET) biosensor protein (T)Epac(VV) in living cells upon activation of the relevant gonadotropin receptor...
February 9, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28174039/bioprocess-integration-for-human-mesenchymal-stem-cells-from-up-to-downstream-processing-scale-up-to-cell-proteome-characterization
#14
Bárbara Cunha, Tiago Aguiar, Sofia B Carvalho, Marta M Silva, Ricardo A Gomes, Manuel J T Carrondo, Patrícia Gomes-Alves, Cristina Peixoto, Margarida Serra, Paula M Alves
To deliver the required cell numbers and doses to therapy, scaling-up production and purification processes (at least to the liter-scale) while maintaining cells' characteristics is compulsory. Therefore, the aim of this work was to prove scalability of an integrated streamlined bioprocess compatible with current good manufacturing practices (cGMP) comprised by cell expansion, harvesting and volume reduction unit operations using human mesenchymal stem cells (hMSC) isolated from bone marrow (BM-MSC) and adipose tissue (AT-MSC)...
February 4, 2017: Journal of Biotechnology
https://www.readbyqxmd.com/read/28162915/simple-in-vitro-generation-of-human-leukocyte-antigen-g-expressing-t-regulatory-cells-through-pharmacological-hypomethylation-for-adoptive-cellular-immunotherapy-against-graft-versus-host-disease
#15
Panagiota Stamou, Dimitra Marioli, Alexandra L Patmanidi, Argyro Sgourou, Angeliki Vittoraki, Efthymia Theofani, Chryso Pierides, Stavros Taraviras, Paul A Costeas, Alexandros Spyridonidis
BACKGROUND: Major barriers in using classical FOXP3+ regulatory T cells (Tregs) in clinical practice are their low numbers in the circulation, the lack of specific cell surface markers for efficient purification and the loss of expression of Treg signature molecules and suppressive function after in vitro expansion or in a pro-inflammatory microenviroment. A surface molecule with potent immunosuppressive function is the human leukocyte antigen-G (HLA-G), which is normally expressed in placenta protecting the "semi-allogeneic" fetus from maternal immune attack...
February 2, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28161122/acute-and-repeated-dose-28-days-toxicity-studies-in-rats-and-dogs-of-recombinant-batroxobin-a-snake-venom-thrombin-like-enzyme-expressed-from-pichia-pastoris
#16
Ok Hwan Kim, Kil-Sang Cho, Young Seomun, Jong-Tak Kim, Kwang-Hoe Chung
Recombinant batroxobin is a thrombin-like enzyme of Bothrops atrox moojeni venom. To evaluate its toxicological effect, it was highly expressed in Pichia pastorisand successfully purified to homogeneity from culture broth supernatant following Good Manufacturing Practice (GMP). The maximum tolerated dose of the recombinant batroxobin was examined in Sprague-Dawley (SD) rat and Beagle dogs following Good Laboratory Practice (GLP) regulations. The approximate lethal dose of recombinant batroxobin was 10 National Institute of Health (NIH) u/kg in male and female rats...
February 1, 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/28154962/expression-of-desmoglein-2-desmocollin-3-and-plakophilin-2-in-placenta-and-bone-marrow-derived-mesenchymal-stromal-cells
#17
Melanie L Hart, Elisa Rusch, Marvin Kaupp, Kay Nieselt, Wilhelm K Aicher
Many controversial results exist when comparing mesenchymal stromal cells (MSCs) derived from different sources. Reasons include not only variables in tissue origin, but also methods of cell preparation or choice of expansion media which can strongly influence the expression and hence, function of the cells. In this short report we aimed to investigate the expression of the cell anchoring proteins desmoglein 2, desmocollin 3 and plakophilin 2 in early passage placenta-derived MSCs of fetal (fetal pMSCs) and maternal (maternal pMSCs) origins versus adult bone marrow-derived MSCs (bmMSCs) that were expanded and cultured under the same good manufacturing practice (GMP) conditions...
February 2, 2017: Stem Cell Reviews
https://www.readbyqxmd.com/read/28154326/marketing-approval-of-ethical-kampo-medicines
#18
Takashi Hakamatsuka
 Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28153778/accelerating-the-clinical-development-of-protein-based-vaccines-for-malaria-by-efficient-purification-using-a-four-amino-acid-c-terminal-c-tag
#19
Jing Jin, Kathryn A Hjerrild, Sarah E Silk, Rebecca E Brown, Geneviève M Labbé, Jennifer M Marshall, Katherine E Wright, Sandra Bezemer, Stine B Clemmensen, Sumi Biswas, Yuanyuan Li, Aadil El-Turabi, Alexander D Douglas, Pim Hermans, Frank J Detmers, Willem A de Jongh, Matthew K Higgins, Rebecca Ashfield, Simon J Draper
Development of bespoke biomanufacturing processes remains a critical bottleneck for translational studies, in particular when modest quantities of a novel product are required for proof-of-concept Phase I/II clinical trials. In these instances the ability to develop a biomanufacturing process quickly and relatively cheaply, without risk to product quality or safety, provides a great advantage by allowing new antigens or concepts in immunogen design to more rapidly enter human testing. These challenges with production and purification are particularly apparent when developing recombinant protein-based vaccines for difficult parasitic diseases, with Plasmodium falciparum malaria being a prime example...
January 30, 2017: International Journal for Parasitology
https://www.readbyqxmd.com/read/28149232/burn-patient-care-lost-in-good-manufacturing-practices
#20
G Dimitropoulos, P Jafari, A de Buys Roessingh, N Hirt-Burri, W Raffoul, L A Applegate
Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as "Advanced Therapy Medicinal Products" (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures...
June 30, 2016: Annals of Burns and Fire Disasters
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