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https://www.readbyqxmd.com/read/28447618/manufacturing-differences-affect-human-bone-marrow-stromal-cell-characteristics-and-function-comparison-of-production-methods-and-products-from-multiple-centers
#1
Shutong Liu, Luis F de Castro, Ping Jin, Sara Civini, Jiaqiang Ren, Jo-Anna Reems, Jose Cancelas, Ramesh Nayak, Georgina Shaw, Timothy O'Brien, David H McKenna, Myriam Armant, Leslie Silberstein, Adrian P Gee, Derek J Hei, Peiman Hematti, Sergei A Kuznetsov, Pamela G Robey, David F Stroncek
Human bone marrow stromal cells (BMSCs, also known as bone marrow-derived mesenchymal stem cells) are manufactured using many different methods, but little is known about the spectrum of manufacturing methods used and their effects on BMSC characteristics and function. Seven centers using, and one developing, Good Manufacturing Practices (GMP) processes were surveyed as to their production methods. Among the seven centers, all used marrow aspirates as the starting material, but no two centers used the same manufacturing methods...
April 27, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28438482/manufacture-and-preparation-of-human-placenta-derived-mesenchymal-stromal-cells-for-local-tissue-delivery
#2
Lee Lankford, Y Julia Chen, Zoe Saenz, Priyadarsini Kumar, Connor Long, Diana Farmer, Aijun Wang
BACKGROUND: In this study we describe the development of a Current Good Manufacturing Practice (CGMP)-compliant process to isolate, expand and bank placenta-derived mesenchymal stromal cells (PMSCs) for use as stem cell therapy. We characterize the viability, proliferation and neuroprotective secretory profile of PMSCs seeded on clinical-grade porcine small intestine submucosa extracellular matrix (SIS-ECM; Cook Biotech). METHODS: PMSCs were isolated from early gestation placenta chorionic villus tissue via explant culture...
April 21, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28427846/vaccines-are-different-a-systematic-review-of-budget-impact-analyses-of-vaccines
#3
REVIEW
Priscilla Magalhaes Loze, Luciana Bertholim Nasciben, Ana Marli Christovam Sartori, Alexander Itria, Hillegonda Maria Dutilh Novaes, Patrícia Coelho de Soárez
INTRODUCTION: Several countries require manufacturers to present a budget impact analysis (BIA), together with a cost-effectiveness analysis, to support national funding requests. However, guidelines for conducting BIA of vaccines are scarce. OBJECTIVES: To analyze the methodological approaches used in published budget impact analysis (BIA) of vaccines, discussing specific methodological issues related to vaccines. MATERIAL AND METHODS: This systematic review of the literature on BIA of vaccines was carried out in accordance with the Centre for Reviews and Dissemination - CRD guidelines...
April 17, 2017: Vaccine
https://www.readbyqxmd.com/read/28408991/transplantation-of-tissue-engineered-cell-sheets-for-stricture-prevention-after-endoscopic-submucosal-dissection-of-the-oesophagus
#4
Eduard Jonas, Sebastian Sjöqvist, Peter Elbe, Nobuo Kanai, Jenny Enger, Stephan L Haas, Ammar Mohkles-Barakat, Teruo Okano, Ryo Takagi, Takeshi Ohki, Masakazu Yamamoto, Makoto Kondo, Katrin Markland, Mei Ling Lim, Masayuki Yamato, Magnus Nilsson, Johan Permert, Pontus Blomberg, J-Matthias Löhr
BACKGROUND AND OBJECTIVE: Endoscopic mucosal dissection (ESD) is a treatment option for oesophagus tumours localized to the mucosa enabling en bloc removal of large lesions. The resulting larger mucosal defects have resulted in an increase in the occurrence of post-treatment strictures. Transplantation of autologous cell sheets, cultured from oral mucosa, has been shown to prevent post-ESD strictures. The aim of the study was to assess the efficacy and safety of cell sheet transplantation after oesophageal ESD in a Western patient population where reflux-associated pre-malignant and malignant conditions predominate...
December 2016: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/28408395/high-throughput-low-loss-low-cost-and-label-free-cell-separation-using-electrophysiology-activated-cell-enrichment
#5
Shabnam A Faraghat, Kai F Hoettges, Max K Steinbach, Daan R van der Veen, William J Brackenbury, Erin A Henslee, Fatima H Labeed, Michael P Hughes
Currently, cell separation occurs almost exclusively by density gradient methods and by fluorescence- and magnetic-activated cell sorting (FACS/MACS). These variously suffer from lack of specificity, high cell loss, use of labels, and high capital/operating cost. We present a dielectrophoresis (DEP)-based cell-separation method, using 3D electrodes on a low-cost disposable chip; one cell type is allowed to pass through the chip whereas the other is retained and subsequently recovered. The method advances usability and throughput of DEP separation by orders of magnitude in throughput, efficiency, purity, recovery (cells arriving in the correct output fraction), cell losses (those which are unaccounted for at the end of the separation), and cost...
April 13, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28403500/nir-spectroscopy-of-actaea-racemosa-l-%C3%A2-rhizome-en-route-to-fast-and-low-cost-quality-assessment
#6
Marian Bittner, Andrea Krähmer, Regina Schenk, Andreas Springer, Gennadi Gudi, Matthias F Melzig
Rhizomes of Actaea racemosa L. (formerly Cimicifuga racemosa) gained increasing interest as a plant-derived drug due to its hormone-like activity and the absence of estrogenic activity. According to the Current Good Manufacturing Practices guidelines and pharmacopeial standards, quality assessment of herbal starting materials includes tests on identity and substitution, as well as quantification of secondary metabolites, usually by HPTLC and LC methods. To reduce the laboratory effort, we investigated near-infrared spectroscopy for rapid species authentication and quantification of metabolites of interest...
April 12, 2017: Planta Medica
https://www.readbyqxmd.com/read/28395097/artesunate-to-treat-severe-malaria-in-travellers-review-of-efficacy-and-safety-and-practical-implications
#7
Camille Roussel, Eric Caumes, Marc Thellier, Papa Alioune Ndour, Pierre A Buffet, Stéphane Jauréguiberry
Background: Artesunate (AS) is the WHO first-line treatment of severe malaria in endemic countries, in adults and children. However, despite solid evidence that AS is safe and more effective than quinine in endemic areas, its deployment in non-endemic areas has been slow, due in part to the absence of a full good manufacturing practice (GMP) qualification (although prequalification has been granted in 2010). Prospective comparative trials were not conducted in travellers, but several retrospective studies and case reports are providing insights into the efficacy and safety of AS in imported severe malaria...
March 1, 2017: Journal of Travel Medicine
https://www.readbyqxmd.com/read/28388226/a-review-of-research-grade-human-induced-pluripotent-stem-cells-qualification-and-biobanking-processes
#8
Aikaterini Ntai, Simona Baronchelli, Alberto La Spada, Anna Moles, Alessandro Guffanti, Pasquale De Blasio, Ida Biunno
Human induced pluripotent stem cell (hiPSC) biobanks are invaluable resources for basic and clinical research, since they provide a sustainable supply of accessible cell lines that meet high quality and safety standards. hiPSCs are particularly useful for understanding disease mechanisms, creating cell models for drug development, and generating novel clinical therapies. For clinical applications and drug discovery, it is fundamental that the acquired pluripotent cell lines never touch animal-derived products nor xenogeneic reagents (Good Manufacturing Practice-grade); whereas for research grade, it is sufficient to operate under Good Laboratory Practice conditions...
April 7, 2017: Biopreservation and Biobanking
https://www.readbyqxmd.com/read/28376825/antiretroviral-therapy-supply-chain-quality-control-and-assurance-in-improving-people-living-with-hiv-therapeutic-outcomes-in-cameroon
#9
M P Ngogang Djobet, David Singhe, Julienne Lohoue, Christopher Kuaban, Jeanne Ngogang, Ernest Tambo
BACKGROUND: Evaluation of medication efficacy and safety is an essential guarantee to successful therapeutic outcome in public health practices. However, larger distribution chain supply in developing countries such as Cameroon is often challenged by counterfeit drugs, poor manufacturing, storage and degradation leading to health and patient adverse consequences. Yet, access to supply chain management in strengthening ARVs quality assurance and outcomes remains poorly documented. More than 53,000 patients have been enrolled on free ARVs medications, but little is documented on quality assurance and validity of safety for affected populations along the supply chain management since 2008...
April 4, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28364523/adipose-stem-cell-function-maintained-with-age-an-intra-subject-study-of-long-term-cryopreserved-cells
#10
Lauren E Kokai, Dmitry O Traktuev, Liyong Zhang, Stephanie Merfeld-Clauss, Gabriella DiBernardo, Hongyan Lu, Kacey G Marra, Albert Donnenberg, Vera Donnenberg, E Michael Meyer, Peter B Fodor, Keith L March, J Peter Rubin
Background: The progressive decline in tissue mechanical strength that occurs with aging is hypothesized to be due to a loss of resident stem cell number and function. As such, there is concern regarding use of autologous adult stem cell therapy in older patients. To abrogate this, many patients elect to cryopreserve the adipose stromal-vascular fraction (SVF) of lipoaspirate, which contains resident adipose stem cells (ASC). However, it is not clear yet if there is any clinical benefit from banking cells at a younger age...
April 1, 2017: Aesthetic Surgery Journal
https://www.readbyqxmd.com/read/28353262/cryopreservation-vitrification-and-controlled-rate-cooling
#11
Charles J Hunt
Cryopreservation is the application of low temperatures to preserve the structural and functional integrity of cells and tissues. Conventional cooling protocols allow ice to form and solute concentrations to rise during the cryopreservation process. The damage caused by the rise in solute concentration can be mitigated by the use of compounds known as cryoprotectants. Such compounds protect cells from the consequences of slow cooling injury, allowing them to be cooled at cooling rates which avoid the lethal effects of intracellular ice...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28345003/expansion-of-human-tregs-from-cryopreserved-umbilical-cord-blood-for-gmp-compliant-autologous-adoptive-cell-transfer-therapy
#12
Howard R Seay, Amy L Putnam, Judit Cserny, Amanda L Posgai, Emma H Rosenau, John R Wingard, Kate F Girard, Morey Kraus, Angela P Lares, Heather L Brown, Katherine S Brown, Kristi T Balavage, Leeana D Peters, Ashley N Bushdorf, Mark A Atkinson, Jeffrey A Bluestone, Michael J Haller, Todd M Brusko
Umbilical cord blood is a traditional and convenient source of cells for hematopoietic stem cell transplantation. Thymic regulatory T cells (Tregs) are also present in cord blood, and there is growing interest in the use of autologous Tregs to provide a low-risk, fully human leukocyte antigen (HLA)-matched cell product for treating autoimmune diseases, such as type 1 diabetes. Here, we describe a good manufacturing practice (GMP)-compatible Treg expansion protocol using fluorescence-activated cell sorting, resulting in a mean 2,092-fold expansion of Tregs over a 16-day culture for a median yield of 1...
March 17, 2017: Molecular Therapy. Methods & Clinical Development
https://www.readbyqxmd.com/read/28339301/cultivation-of-human-oral-mucosal-explants-on-contact-lenses
#13
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-%C3%A2-coli
#14
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
#15
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
#16
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
#17
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
#18
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...
April 7, 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
#19
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
#20
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
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