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Good manufacturing practice

Ichiro Higashikubo, Heihachiro Arito, Kenji Ando, Akihiro Araki, Hidesuke Shimizu, Haruhiko Sakurai
OBJECTIVES: This study aimed to assess workers' exposure to indium and its compounds in 55 indium-handling operations among 13 Japanese plants. The surveyed plants were selected from indium-manufacturing plants whose annual indium production exceeded 500 kg. METHODS: The Control of Substances Hazardous to Health (COSHH) Essentials control banding toolkit, which contains simple scales for hazard levels, quantities in daily use, and "dustiness" characteristics, was used to assess generic risks of indium-handling operations...
March 20, 2018: Journal of Occupational Health
Cyril Jacquot, Meghan Delaney
The US blood supply has never been safer. This level of safety depends on a multifaceted approach including blood donor screening, sensitive infectious disease testing, and good manufacturing practice. However, risks remain for transfusion-transmitted infections due to bacterial contamination of platelets and emerging diseases. Thus, ongoing improvements in screening and testing are required. Newer pathogen reduction technologies have shown promise in further ameliorating the safety of the blood supply.
January 1, 2018: Journal of Intensive Care Medicine
Noa Sher, Racheli Ofir
The ephemeral placenta provides a noncontroversial source of young, healthy cells of both maternal and fetal origin from which cell therapy products can be manufactured. The 2 advantages of using live cells as therapeutic entities are: (a) in their environmental-responsive, multifactorial secretion profile and (b) in their activity as a "slow-release drug delivery system," releasing secretions over a long time frame. A major difficulty in translating cell therapy to the clinic involves challenges of large-scale, robust manufacturing while maintaining product characteristics, identity, and efficacy...
January 2018: Cell Transplantation
A Leiva, F Granados-Chinchilla, M Redondo-Solano, M Arrieta-González, E Pineda-Salazar, A Molina
Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process.An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i...
March 19, 2018: Poultry Science
Henrieta Fraser, Niloufar Safinia, Nathali Grageda, Sarah Thirkell, Katie Lowe, Laura J Fry, Cristiano Scottá, Andrew Hope, Christopher Fisher, Rachel Hilton, David Game, Paul Harden, Andrew Bushell, Kathryn Wood, Robert I Lechler, Giovanna Lombardi
The concept of regulatory T cell (Treg)-based immunotherapy has enormous potential for facilitating tolerance in autoimmunity and transplantation. Clinical translation of Treg cell therapy requires production processes that satisfy the rigors of Good Manufacturing Practice (GMP) standards. In this regard, we report our findings on the implementation of a robust GMP compliant process for the ex vivo expansion of clinical grade Tregs, demonstrating the feasibility of this developed process for the manufacture of a final product for clinical application...
March 16, 2018: Molecular Therapy. Methods & Clinical Development
Lucía Fernández, Alejandra Leivas, Jaime Valentín, Adela Escudero, Dolores Corral, Raquel de Paz, Maria Vela, David Bueno, Rebeca Rodríguez, Juan Manuel Torres, Mariana Díaz-Almirón, Eduardo López-Collazo, Joaquin Martinez-Lopez, Antonio Pérez-Martínez
BACKGROUND: Cancer immunotherapy involving natural killer (NK) cells has gained interest. Here we report two methods to obtain interleukin (IL)-15-activated NK cells for clinical use. STUDY DESIGN AND METHODS: IL-15-activated NK cell products were obtained after 1) enrichment from healthy haploidentical donors' peripheral blood mononuclear cells (PBMNCs) collected by nonmobilized apheresis by a two-step magnetic procedure, depletion of CD3+ cells followed by selection of CD56+ cells and ex vivo overnight stimulation with IL-15 (NKIL15); and 2) expansion using the K562-mb15-41BBL cell line (NKAE), from autologous PBMNCs from patients with multiple myeloma or expansion from healthy haploidentical PBMNCs obtained from whole blood using the same previous cell line...
March 14, 2018: Transfusion
Maria Hayes
By 2050, the world population is estimated to reach 9.6 billion, and this growth continues to require more food, particularly proteins. Moreover, the Westernisation of society has led to consumer demand for protein products that taste good and are convenient to consume, but additionally have nutritional and health maintenance and well-being benefits. Proteins provide energy, but additionally have a wide range of functions from enzymatic activities in the body to bioactivities including those associated with heart health, diabetes-type 2-prevention and mental health maintenance; stress relief as well as a plethora of other health beneficial attributes...
March 14, 2018: Foods (Basel, Switzerland)
Xiaobin Xu, Shuang Hou, Natcha Wattanatorn, Fang Wang, Qing Yang, Chuanzhen Zhao, Xiao Yu, Hsian-Rong Tseng, Steven J Jonas, Paul S Weiss
An efficient nonviral platform for high-throughput and subcellular precision targeted intracellular delivery of nucleic acids in cell culture based on magnetic nanospears is reported. These magnetic nanospears are made of Au/Ni/Si (∼5 μm in length with tip diameters <50 nm) and fabricated by nanosphere lithography and metal deposition. A magnet is used to direct the mechanical motion of a single nanospear, enabling precise control of position and three-dimensional rotation. These nanospears were further functionalized with enhanced green fluorescent protein (eGFP)-expression plasmids via a layer-by-layer approach before release from the underlying silicon substrate...
March 14, 2018: ACS Nano
Shelly M Williams, Darin Sumstad, Diane Kadidlo, Julie Curtsinger, Xianghua Luo, Jeffrey S Miller, David H McKenna
BACKGROUND: Allogeneic natural killer (NK) cell adoptive immunotherapy is a growing therapeutic option for patients. Clinical-scale production of NK cells using immunomagnetic selection complies with current good manufacturing practices (cGMPs) and allows for closed-system, automated purification. We report our experience with CD3/CD19 cell-depleted (CD3/CD19dep ) NK cell production and compare to previous methods of CD3 cell depletion and CD3 cell depletion/CD56 cell enrichment. STUDY DESIGN AND METHODS: Nonmobilized mononuclear cells collected by apheresis were incubated with anti-CD3/anti-CD19 microbeads and depleted in an automated cell selection system (CliniMACS, Miltenyi)...
March 12, 2018: Transfusion
Valentina Coccè, Anna Brini, Aldo Bruno Giannì, Valeria Sordi, Angiola Berenzi, Giulio Alessandri, Carlo Tremolada, Silvia Versari, Antonio Bosetto, Augusto Pessina
The adipose tissue is a good source of mesenchymal stromal cells that requires minimally invasive isolation procedures. To ensure reproducibility, efficacy, and safety for clinical uses, these procedures have to be in compliant with good manufacturing practices. Techniques for harvesting and processing human adipose tissue have rapidly evolved in the last years, and Lipogems® represents an innovative approach to obtain microfragmented adipose tissue in a short time, without expansion and/or enzymatic treatment...
2018: Stem Cells International
Babak Behnam Azad, Daniel P Holt, Hayden T Ravert, Andrew G Horti, Robert F Dannals
In this concise practitioner protocol, the radiochemical synthesis of [18 F]FNDP suitable for human PET studies is described and the results from validation productions are presented. The high specific activity radiotracer product is prepared as a sterile, apyrogenic solution that conforms to current Good Manufacturing Practice (cGMP) requirements.
March 12, 2018: Journal of Labelled Compounds & Radiopharmaceuticals
Paulo Pereira, Jerard Seghatchian, Beatriz Caldeira, Sandra Xavier, Gracinda de Sousa
General quality control good practices require the control of the production of blood components using statistical techniques, such as mandatory by the European Commission Directives and the American Association of Blood Banks standards. Sometimes, the control procedure is exclusively in favor of the compliance verification with specifications per individual component or to compute the number of defective parts usually on a monthly basis. However, this is a critical restriction to detect unnatural patterns such as to guarantee that the production has a non-significance chance to manufacturing nonconforming components...
February 20, 2018: Transfusion and Apheresis Science
Michael Creane, Mary Mc Elroy, Aoife Duffy, Chaansha Shaik Dawood, Timothy O'Brien
Critical limb ischemia (CLI) represents the severest manifestation of peripheral arterial disease and is a major unmet medical need. This disease occurs when the arterial blood supply within the limb fails to meet the metabolic demands of the resting muscle or tissue, resulting in chronic ischemic rest pain and/or tissue necrosis. Human mesenchymal stromal cells, termed hMSCs, represent an exciting therapeutic modality for the treatment of this disease due to their immunomodulatory and tissue reparative functions...
January 1, 2018: Toxicologic Pathology
M A Tulina, N V Pyatigorskaya
The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations...
March 4, 2018: Bulletin of Experimental Biology and Medicine
Nina Müller, Katharina Landwehr, Kirsten Langeveld, Joanna Stenzel, Walter Pouwels, Menno A W G van der Hoorn, Erhard Seifried, Halvard Bonig
BACKGROUND AIMS: For patients needing allogeneic stem cell transplantation but lacking a major histocompatibility complex (MHC)-matched donor, haplo-identical (family) donors may be an alternative. Stringent T-cell depletion required in these cases to avoid lethal graft-versus-host disease (GVHD) can delay immune reconstitution, thus impairing defense against virus reactivation and attenuating graft-versus-leukemia (GVL) activity. Several groups reported that GVHD is caused by cells residing within the naive (CD45RA+ ) T-cell compartment and proposed use of CD45RA-depleted donor lymphocyte infusion (DLI) to accelerate immune reconstitution...
February 28, 2018: Cytotherapy
John Mills, Kylie Marree Horváth, Angela Denise Reynolds, Gale Brightwell
AIMS: To investigate the transmission route of Carnobacterium from the farm environment to the meat-manufacturing plant and potential risk for meat spoilage. METHODS AND RESULTS: A sheep farm level survey of Carnobacterium, consisting of 150 environmental and animal (no 100) associated samples, was carried out on two farms. A further 20 lamb carcass samples were taken from an abattoir servicing one of the farms. The majority of C. maltaromaticum isolates were associated with fleece followed by hard sheep contact surfaces, rectal-anal-mucosal swabs and carcasses...
March 1, 2018: Journal of Applied Microbiology
Oliver Petters, Christian Schmidt, Ralf Henkelmann, Philipp Pieroh, Gero Hütter, Bastian Marquaß, Gabriela Aust, Ronny Maik Schulz
Due to the limited self-healing capacity of articular cartilage, innovative, regenerative approaches are of particular interest. The use of two-stage procedures utilizing in vitro expanded mesenchymal stromal cells (MSCs) from various cell sources requires good manufacturing practice-compliant production, a process with high demands on time, staffing and financial resources. In contrast, one- stage procedures are directly available but need a safe enrichment of potent MSCs. CD271 is a surface marker known to marking the majority of native MSCs in bone marrow...
February 26, 2018: Stem Cells and Development
Emmanuelle Varlet-Marie, Yvon Sterkers, Marina Perrotte, Patrick Bastien
Toxoplasmosis is generally a benign infection caused by the protozoan parasite Toxoplasma gondii but can have severe consequences in fetuses of mothers infected during pregnancy (congenital toxoplasmosis) and immunocompromised individuals. PCR-based diagnostic tests have become crucial for its diagnosis. However, this molecular diagnosis essentially relies upon laboratory-developed methods and suffers from a lack of standardization, leading to great variation in methods and performance among laboratories. With the need for accreditation of clinical microbiological laboratories, the use of commercial PCR kits has become an attractive alternative; but thorough evaluation of newly commercialized kits by proficient groups is necessary before any recommendation can be made to parasitology laboratories by health authorities or learned societies...
February 22, 2018: International Journal for Parasitology
Georg Siegel, Erika Fleck, Stefanie Elser, Ursula Hermanutz-Klein, Marc Waidmann, Hinnak Northoff, Erhard Seifried, Richard Schäfer
BACKGROUND: Endothelial colony-forming progenitor cells (ECFCs) are promising candidates for cell therapies. However, ECFC translation to the clinic requires optimized isolation and manufacture technologies according to good manufacturing practice (GMP). STUDY DESIGN AND METHODS: ECFCs were manufactured from steady-state peripheral blood (PB) leukapheresis (11 donors), using GMP-compliant technologies including pooled human platelet (PLT) lysate, and compared to human umbilical cord endothelial cells, human aortic endothelial cells, and human cerebral microvascular endothelial cells...
February 22, 2018: Transfusion
Shyan Yea Chay, Annas Salleh, Nor Fazila Sulaiman, Najib Zainal Abidin, Mohamad Ariff Hanafi, Mohammad Zarei, Nazamid Saari
Winged bean seed (WBS) is an underutilized tropical crop. The current study evaluates its potential to reduce blood pressure (BP) in spontaneously hypertensive rats and finds that it reduces BP significantly, in a dose-dependent manner. Five peptides with the sequences, RGVFPCLK, TQLDLPTQ, EPALVP, MRSVVT and DMKP, have been characterized in terms of their stability against ACE via in vitro and in silico modelling. All peptides exhibited IC50 values between 0.019 and 6.885 mM and various inhibitory modes, including substrate, prodrug and true inhibitor modes...
February 22, 2018: Food & Function
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