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https://www.readbyqxmd.com/read/28339301/cultivation-of-human-oral-mucosal-explants-on-contact-lenses
#1
Barbara Zsebik, László Ujlaky-Nagy, Gergely Losonczy, György Vereb, Lili Takács
Purpose/Aim: Autologous cultivated oral mucosal (OM) epithelial transplantation has been successfully used as corneal epithelial replacement in bilateral limbal stem cell deficiency. Recently, lotrafilcon A contact lens (CL) surface was described as a suitable carrier for cultured stem cells in corneal epithelial transplantation. Our aim was to establish explant cultures from human OM on CL carriers that are free of animal-derived materials and feeder cells. MATERIALS AND METHODS: Human cadaveric 2 mm OM explants were sutured onto CL surfaces and cultivated with fetal calf serum (FCS) or human serum (HS) supplemented culture medium without feeder cells...
March 24, 2017: Current Eye Research
https://www.readbyqxmd.com/read/28336201/a-facile-method-for-isolation-of-recombinant-human-apolipoprotein-a-i-from-e-coli
#2
Nikita Ikon, Jennifer Shearer, Jianfang Liu, Jesse J Tran, ShiBo Feng, Ayako Kamei, Jennifer A Beckstead, Robert S Kiss, Paul M Weers, Gang Ren, Robert O Ryan
Apolipoprotein (apo) A-I is the major protein component of high-density lipoprotein (HDL) and plays key roles in the Reverse Cholesterol Transport pathway. In the past decade, reconstituted HDL (rHDL) has been employed as a therapeutic agent for treatment of atherosclerosis. The ability of rHDL to promote cholesterol efflux from peripheral cells has been documented to reduce the size of atherosclerotic plaque lesions. However, development of apoA-I rHDL-based therapeutics for human use requires a cost effective process to generate an apoA-I product that meets "Good Manufacturing Practice" standards...
March 20, 2017: Protein Expression and Purification
https://www.readbyqxmd.com/read/28321422/autologous-tenocyte-injection-for-the-treatment-of-chronic-recalcitrant-gluteal-tendinopathy-a-prospective-pilot-study
#3
Thomas A Bucher, Jay R Ebert, Anne Smith, William Breidahl, Michael Fallon, Tao Wang, Ming-Hao Zheng, Gregory C Janes
BACKGROUND: Gluteal tendinopathy is a common cause of lateral hip pain, and existing conservative treatment modalities demonstrate high symptom recurrence rates. Autologous tenocyte injection (ATI) is a promising cell therapy that may be useful for the treatment of gluteal tendinopathy. PURPOSE: To investigate the safety and effectiveness of ATI, specifically in patients with chronic recalcitrant gluteal tendinopathy. STUDY DESIGN: Case series; Level of evidence, 4...
February 2017: Orthopaedic Journal of Sports Medicine
https://www.readbyqxmd.com/read/28316269/development-of-a-novel-one-step-production-system-for-injectable-liposomes-under-gmp
#4
Ryo Araki, Takashi Matsuzaki, Ayumi Nakamura, Daisaku Nakatani, Shoji Sanada, Hai Ying Fu, Keiji Okuda, Masaki Yamato, Shota Tsuchida, Yasushi Sakata, Tetsuo Minamino
There are few methods available for injectable liposome production under good manufacturing practices (GMP). Injectable liposome production processes under GMP generally consist of liposome formation, size homogenization, organic solvent removal, liposome concentration control and sterilization. However, these complicated and separate processes make it difficult to maintain scalability, reproducibility and sterility. To overcome these limitations, we developed a novel one-step in-line closed liposome production system that integrated all production processes by combining the in-line thermal mixing device with modified counterflow dialysis...
March 20, 2017: Pharmaceutical Development and Technology
https://www.readbyqxmd.com/read/28295334/artisanal-sonoran-cheese-cocido-cheese-an-exploration-of-its-production-process-chemical-composition-and-microbiological-quality
#5
Paúl F Cuevas-González, Priscilia Y Heredia-Castro, José I Méndez-Romero, Adrián Hernández-Mendoza, Ricardo Reyes-Díaz, Belinda Vallejo-Cordoba, Aarón F González-Córdova
BACKGROUND: The objective of this study was to explore and document the production process of artisanal Cocido cheese and to determine its chemical composition and microbiological quality, considering samples from six dairies and four retailers. RESULTS: Cocido cheese is a semi-hard (506-555 g Kg(-1) of moisture), medium fat (178.3-219.1 g Kg(-1) ), pasta filata type cheese made from raw whole cow's milk. The production process is not standardized, and, therefore, the chemical and microbiological components of the sampled cheeses varied...
March 10, 2017: Journal of the Science of Food and Agriculture
https://www.readbyqxmd.com/read/28284763/validation-of-a-two-dimensional-liquid-chromatography-method-for-quality-control-testing-of-pharmaceutical-materials
#6
Samuel H Yang, Jenny Wang, Kelly Zhang
Despite the advantages of 2D-LC, there is currently little to no work in demonstrating the suitability of these 2D-LC methods for use in a quality control (QC) environment for good manufacturing practice (GMP) tests. This lack of information becomes more critical as the availability of commercial 2D-LC instrumentation has significantly increased, and more testing facilities begin to acquire these 2D-LC capabilities. It is increasingly important that the transferability of developed 2D-LC methods be assessed in terms of reproducibility, robustness and performance across different laboratories worldwide...
March 1, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28279187/pulp-regeneration-by-transplantation-of-dental-pulp-stem-cells-in-pulpitis-a-pilot-clinical-study
#7
Misako Nakashima, Koichiro Iohara, Masashi Murakami, Hiroshi Nakamura, Yayoi Sato, Yoshiko Ariji, Kenji Matsushita
BACKGROUND: Experiments have previously demonstrated the therapeutic potential of mobilized dental pulp stem cells (MDPSCs) for complete pulp regeneration. The aim of the present pilot clinical study is to assess the safety, potential efficacy, and feasibility of autologous transplantation of MDPSCs in pulpectomized teeth. METHODS: Five patients with irreversible pulpitis were enrolled and monitored for up to 24 weeks following MDPSC transplantation. The MDPSCs were isolated from discarded teeth and expanded based on good manufacturing practice (GMP)...
March 9, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/28268949/teaching-biomedical-design-through-a-university-industry-partnership
#8
Lunal Khuon, Karl R Zum, Jane B Zurn, Gerald M Herrera
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/28263994/multi-objective-agv-scheduling-in-an-fms-using-a-hybrid-of-genetic-algorithm-and-particle-swarm-optimization
#9
Maryam Mousavi, Hwa Jen Yap, Siti Nurmaya Musa, Farzad Tahriri, Siti Zawiah Md Dawal
Flexible manufacturing system (FMS) enhances the firm's flexibility and responsiveness to the ever-changing customer demand by providing a fast product diversification capability. Performance of an FMS is highly dependent upon the accuracy of scheduling policy for the components of the system, such as automated guided vehicles (AGVs). An AGV as a mobile robot provides remarkable industrial capabilities for material and goods transportation within a manufacturing facility or a warehouse. Allocating AGVs to tasks, while considering the cost and time of operations, defines the AGV scheduling process...
2017: PloS One
https://www.readbyqxmd.com/read/28236560/the-dynamics-of-contract-plasma-fractionation
#10
REVIEW
Albert Farrugia, Daniela Scaramuccia
Plasma Derived Medicinal Products (PMDPs) are an essential component of the modern therapeutic armamentarium. They are differentiated from most other medicines in several ways, particularly the unique nature of the raw material used for their manufacture. Human plasma has been fractionated to PDMPs for the past 75 years, and the economics of manufacturing requires currently that as many products are harvested from each litre as is feasible and reflective of clinical needs. PDMPs may be purchased on the open market from the various commercial and not-for-profit (NFP) manufacturers...
February 21, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28236559/an-external-dosimetry-audit-programme-to-credential-static-and-rotational-imrt-delivery-for-clinical-trials-quality-assurance
#11
David J Eaton, Justine Tyler, Alex Backshall, David Bernstein, Antony Carver, Anne Gasnier, Julia Henderson, Jonathan Lee, Rushil Patel, Yatman Tsang, Huiqi Yang, Rada Zotova, Emma Wells
PURPOSE: External dosimetry audits give confidence in the safe and accurate delivery of radiotherapy. The RTTQA group have performed an on-site audit programme for trial recruiting centres, who have recently implemented static or rotational IMRT, and those with major changes to planning or delivery systems. METHODS: Measurements of reference beam output were performed by the host centre, and by the auditor using independent equipment. Verification of clinical plans was performed using the ArcCheck helical diode array...
February 21, 2017: Physica Medica: PM
https://www.readbyqxmd.com/read/28227155/teaching-biomedical-design-through-a-university-industry-partnership
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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