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Good manufacturing practice

Fabienne Hartmann-Fritsch, Daniela Marino, Ernst Reichmann
BACKGROUND: The treatment of severe full-thickness skin defects represents a significant and common clinical problem worldwide. A bio-engineered autologous skin substitute would significantly reduce the problems observed with today's gold standard. METHODS: Within 15 years of research, the Tissue Biology Research Unit of the University Children's Hospital Zurich has developed autologous tissue-engineered skin grafts based on collagen type I hydrogels. Those products are considered as advanced therapy medicinal products (ATMPs) and are routinely produced for clinical trials in a clean room facility following the guidelines for good manufacturing practice (GMP)...
September 2016: Transfusion Medicine and Hemotherapy
Caijun Yang, Lina Wu, Wenfang Cai, Wenwen Zhu, Qian Shen, Zongjie Li, Yu Fang
OBJECTIVE: Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. METHODS: A qualitative methodological approach was conducted during May-June 2015 and December 2015-January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities...
2016: PloS One
Jennifer E Adair, Timothy Waters, Kevin G Haworth, Sara P Kubek, Grant D Trobridge, Jonah D Hocum, Shelly Heimfeld, Hans-Peter Kiem
Haematopoietic stem cell (HSC) gene therapy has demonstrated potential to treat many diseases. However, current state of the art requires sophisticated ex vivo gene transfer in a dedicated Good Manufacturing Practices facility, limiting availability. An automated process would improve the availability and standardized manufacture of HSC gene therapy. Here, we develop a novel program for semi-automated cell isolation and culture equipment to permit complete benchtop generation of gene-modified CD34(+) blood cell products for transplantation...
October 20, 2016: Nature Communications
Alexandra Condé-Green, Vasanth S Kotamarti, Lauren S Sherman, Jonathan D Keith, Edward S Lee, Mark S Granick, Pranela Rameshwar
: Standard isolation of adipose stromal vascular fraction (SVF) requires the use of collagenase and is considered more than "minimally manipulated" by current good manufacturing practice requirements. Alternatively, nonenzymatic isolation methods have surfaced using physical forces to separate cells from the adipose matrix. The purpose of this study was to review the literature on the use of mechanical isolation protocols and compare the results. The implication for use as a standard procedure in practice is discussed...
September 2016: Plastic and Reconstructive Surgery. Global Open
Liu Sifei, Zhang Guangrui, Qiu Ying, Wang Xiaobo, Guo Lihan, Zhao Yanxin, Tong Meng, Wei Lan, Sun Lixin
In this study, we aimed to establish a comprehensive and practical quality evaluation system for Shenmaidihuang pills. A simple and reliable high-performance liquid chromatography coupled with photodiode array detection method was developed both for fingerprint analysis and quantitative determination. In fingerprint analysis, relative retention time and relative peak area were used to identify the common peaks in 18 samples for investigation. 21 peaks were selected as the common peaks to evaluate the similarities of 18 Shenmaidihuang pills samples with different manufacture dates...
October 14, 2016: Journal of Separation Science
Animesh Tandon, Lorraine James, Markus Henningsson, René M Botnar, Amanda Potersnak, Gerald F Greil, Tarique Hussain
BACKGROUND: The use of gadolinium contrast agents in cardiovascular magnetic resonance is well-established and serves to improve both vascular imaging as well as enable late gadolinium enhancement (LGE) imaging for tissue characterization. Currently, gadofosveset trisodium, an intravascular contrast agent, combined with a three-dimensional inversion recovery balanced steady state free precession (3D IR bSSFP) sequence, is commonly used in pediatric cardiac imaging and yields excellent vascular imaging, but cannot be used for late gadolinium enhancement...
October 5, 2016: Journal of Cardiovascular Magnetic Resonance
Gilles Salvat, Marie Guyot, Juliette Protino
AIM: "Label Rouge" broiler free-range carcasses have been monitored since 1991, and broiler flocks since 2010, for contamination by the main foodborne zoonotic bacteria. MATERIAL AND METHODS: Initially the monitoring plan mainly focused on the surveillance of Salmonella, and on indicators of the overall microbiological quality of free-range broiler carcasses such as S. aureus and coliforms, but was extended in 2007 to include Campylobacter enumeration on carcasses and in 2010 to Salmonella in the environment of live birds...
October 4, 2016: Journal of Applied Microbiology
Bart W Faber, Stephan Hellwig, Sophie Houard, Nicolas Havelange, Jürgen Drossard, Hubert Mertens, Alexander Croon, Robin Kastilan, Richard Byrne, Nicole van der Werff, Marjolein van der Eijk, Alan W Thomas, Clemens H M Kocken, Edmond J Remarque
Plasmodium falciparum apical membrane antigen 1 (PfAMA1) is a leading asexual blood stage vaccine candidate for malaria. In preparation for clinical trials, three Diversity Covering (DiCo) PfAMA1 ectodomain proteins, designed to overcome the intrinsic polymorphism that is present in PfAMA1, were produced under Good Manufacturing Practice (GMP) in Pichia pastoris. Using identical methodology, the 3 strains were cultivated in 70-L scale fed-batch fermentations and PfAMA1-DiCos were purified by two chromatography steps, an ultrafiltration/diafiltration procedure and size exclusion chromatography, resulting in highly pure (>95%) PfAMA1-DiCo1, PfAMA1 DiCo2 and PfAMA1 DiCo3, with final yields of 1...
2016: PloS One
Salvi Prat, Santiago Gallardo-Villares, Marian Vives, Ana Carreño, Marta Caminal, Irene Oliver-Vila, Daniel Chaverri, Margarita Blanco, Margarita Codinach, Pere Huguet, José Ramírez, Javier A Pinto, Màrius Aguirre, Ruth Coll, Joan Garcia-López, Fernando Granell-Escobar, Joaquim Vives
Pseudoarhtrosis is a relatively frequent complication of fractures, in which the lack of mechanical stability and biological stimuli results in the failure of bone union, most frequently in humerus and tibia. Treatment of recalcitrant pseudoarthrosis relies on the achievement of satisfactory mechanical stability combined with adequate local biology. Herein we present two cases of atrophic pseudoarthrosis that received a Tissue Engineering Product (TEP) composed of autologous Bone Marrow-derived Mesenchymal Stromal Cells (BM-MSC) combined with deantigenised trabecular bone particles from tissue bank...
September 29, 2016: Journal of Tissue Engineering and Regenerative Medicine
P A De Sousa, J M Downie, B J Tye, K Bruce, P Dand, S Dhanjal, P Serhal, J Harper, M Turner, M Bateman
From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources...
August 26, 2016: Stem Cell Research
Alvaro A Ordonez, Edward A Weinstein, Lauren E Bambarger, Vikram Saini, Yong S Chang, Vincent P DeMarco, Mariah H Klunk, Michael E Urbanowski, Kimberly L Moulton, Allison M Murawski, Supriya Pokkali, Alvin S Kalinda, Sanjay K Jain
: The modern patient is increasingly susceptible to bacterial infections including those due to multi-drug resistant organisms (MDROs). Noninvasive whole-body analysis with pathogen-specific imaging technologies can significantly improve patient outcomes by rapidly identifying a source of infection and monitoring the response to treatment, but no such technology exists clinically. METHODS: We systematic screened 961 random, radiolabeled molecules in silico as substrates for essential metabolic pathways in bacteria, followed by in vitro uptake in representative bacteria - Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and mycobacteria...
September 15, 2016: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
Mariëtte I E van Poelgeest, Valeria V Visconti, Zohara Aghai, Vanessa J van Ham, Moniek Heusinkveld, Maarten L Zandvliet, A Rob P M Valentijn, Renske Goedemans, Caroline E van der Minne, Els M E Verdegaal, J Baptist M Z Trimbos, Sjoerd H van der Burg, Marij J P Welters
Adoptive transfer of tumor-specific T cells, expanded from tumor-infiltrating lymphocytes or from peripheral blood, is a promising immunotherapeutic approach for the treatment of cancer. Here, we studied whether the tumor-draining lymph nodes (TDLN) of patients with human papillomavirus (HPV)-induced cervical cancer can be used as a source for ACT. The objectives were to isolate lymph node mononuclear cells (LNMC) from TDLN and optimally expand HPV-specific CD4+ and CD8+ T cells under clinical grade conditions...
September 12, 2016: Cancer Immunology, Immunotherapy: CII
Jingchao Hu, Yu Cao, Yilin Xie, Hua Wang, Zhipeng Fan, Jinsong Wang, Chunmei Zhang, Jinsong Wang, Chu-Tse Wu, Songlin Wang
BACKGROUND: Periodontitis, one of the most prevalent infectious diseases in humans, results in the destruction of tooth-supporting tissues. The purpose of the present study is to evaluate the effect of cell injection and cell sheet transplantation on periodontal regeneration in a swine model. METHODS: In the present study, human dental pulp stem cells (hDPSCs) were transplanted into a swine model for periodontal regeneration. Twelve miniature pigs were used to generate periodontitis with bone defects of 5 mm in width, 7 mm in length, and 3 mm in depth...
2016: Stem Cell Research & Therapy
Hans-Jörg Helmlin, André Mürner, Samuel Steiner, Matthias Kamber, Christina Weber, Hans Geyer, Sven Guddat, Wilhelm Schänzer, Mario Thevis
Hydrochlorothiazide (HCTZ, 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide) belongs to the class of diuretic agents that represent one of today's cornerstones of the treatment of hypertensive patients. In addition to its clinical relevance, HCTZ is prohibited in sports according to the regulations of the World Anti-Doping Agency (WADA) at all times and has frequently been detected in sports drug testing urine samples worldwide since its ban was introduced in 1988. Despite these facts, the adverse analytical finding concerning HCTZ in an in-competition routine doping control sample collected in December 2014 was further investigated, particularly motivated by the comparably low urinary concentration of the drug accounting for approximately 5ng/mL...
October 2016: Forensic Science International
Takao Shimizu, Kiliha Katayama, Takanori Kiguchi, Akihiro Akama, Toyohiko J Konno, Osami Sakata, Hiroshi Funakubo
Ferroelectricity and Curie temperature are demonstrated for epitaxial Y-doped HfO2 film grown on (110) yttrium oxide-stabilized zirconium oxide (YSZ) single crystal using Sn-doped In2O3 (ITO) as bottom electrodes. The XRD measurements for epitaxial film enabled us to investigate its detailed crystal structure including orientations of the film. The ferroelectricity was confirmed by electric displacement filed - electric filed hysteresis measurement, which revealed saturated polarization of 16 μC/cm(2). Estimated spontaneous polarization based on the obtained saturation polarization and the crystal structure analysis was 45 μC/cm(2)...
2016: Scientific Reports
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...
September 2, 2016: Stem Cells Translational Medicine
Kerry Dwan, Stephen J Milan, Lynne Bax, Nicola Walters, Colin Powell
BACKGROUND: Vilanterol (VI) is a long-acting beta2-agonist (LABA) that binds to the beta2-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy...
September 1, 2016: Cochrane Database of Systematic Reviews
Jennifer L Harris, Maia Hyary, Marlene B Schwartz
BACKGROUND: In 2014, USDA established nutrition standards for snack foods sold in schools. Many manufacturers reformulated products to meet these Smart Snacks standards, but continue to advertise unhealthy versions of the same brands. Furthermore, Smart Snack packaging often looks similar to less nutritious versions sold outside of schools (look-alike products). This practice may confuse consumers about the nutritional quality of Smart Snacks and raise concerns about schools selling them...
August 30, 2016: Childhood Obesity
Ángela Usarralde-Pérez, Piedad Toro-Chico, Montserrat Pérez-Encinas
OBJECTIVE: To establish limits of validity to opened or reconstituted vials and cytostatic mixtures according to their physico- chemical stability and the level of risk and preparation requirements. The level of risk and preparation requirements were assigned by the risk matrix the Guide of Good Practice of Preparation of Drugs in Hospital Pharmacy Services. METHOD: A table of stabilities of cytostatic drugs was developed. Physicochemical stability data were obtained from data sheets and literature reviews...
July 2016: Farmacia Hospitalaria
Rémy Bétous, Marie-Laure Renoud, Claire Hoede, Ignacio Gonzalez, Natalie Jones, Michel Longy, Luc Sensebé, Christophe Cazaux, Jean-Sébastien Hoffmann
: : Adipose-derived stem cells (ADSCs) have led to growing interest in cell-based therapy because they can be easily harvested from an abundant tissue. ADSCs must be expanded in vitro before transplantation. This essential step causes concerns about the safety of adult stem cells in terms of potential transformation. Tumorigenesis is driven in its earliest step by DNA replication stress, which is characterized by the accumulation of stalled DNA replication forks and activation of the DNA damage response...
August 24, 2016: Stem Cells Translational Medicine
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