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https://www.readbyqxmd.com/read/29150937/cgmp-production-and-analysis-of-bg505-sosip-664-an-extensively-glycosylated-trimeric-hiv-1-envelope-glycoprotein-vaccine-candidate
#1
Antu K Dey, Albert Cupo, Gabriel Ozorowski, Vaneet K Sharma, Anna-Janina Behrens, Eden P Go, Thomas J Ketas, Anila Yasmeen, Per J Klasse, Eddy Sayeed, Heather Desaire, Max Crispin, Ian A Wilson, Rogier W Sanders, Thomas Hassell, Andrew Ward, John P Moore
We describe the properties of BG505 SOSIP.664 HIV-1 envelope glycoprotein trimers produced under current Good Manufacturing Practice (cGMP) conditions. These proteins are the first of a new generation of native-like trimers that are the basis for many structure-guided immunogen development programs aimed at devising how to induce broadly neutralizing antibodies (bNAbs) to HIV-1 by vaccination. The successful translation of this prototype demonstrates the feasibility of producing similar immunogens on an appropriate scale and of an acceptable quality for Phase I experimental medicine clinical trials...
November 18, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29138881/a-harmonized-immunoassay-with-liquid-chromatography-mass-spectrometry-analysis-in-egg-allergen-determination
#2
Masaomi Nimata, Hideki Okada, Kei Kurihara, Tsukasa Sugimoto, Tsutomu Honjoh, Kazuhiko Kuroda, Takeo Yano, Hirofumi Tachibana, Masahiro Shoji
Food allergy is a serious health issue worldwide. Implementing allergen labeling regulations is extremely challenging for regulators, food manufacturers, and analytical kit manufacturers. Here we have developed an "amino acid sequence immunoassay" approach to ELISA. The new ELISA comprises of a monoclonal antibody generated via an analyte specific peptide antigen and sodium lauryl sulfate/sulfite solution. This combination enables the antibody to access the epitope site in unfolded analyte protein. The newly developed ELISA recovered 87...
November 14, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29130351/the-gene-therapy-resource-program-a-decade-of-dedication-to-translational-research-by-the-national-heart-lung-and-blood-institute
#3
Terence R Flotte, Eric Daniels, Janet Benson, Jenee M Bevett-Rose, Kenneth Cornetta, Margaret Diggins, Julie Johnston, Susan Sepelak, Johannes Van Der Loo, James M Wilson, Cheryl L McDonald
Over a ten-year period, the Gene Therapy Resource Program (GTRP) of the National Heart Lung and Blood Institute (NHLBI) has provided a set of core services to investigators to facilitate the clinical translation of gene therapy. These services have included a preclinical (research-grade) vector production core; current Good Manufacturing Practice (cGMP) clinical-grade vector cores for recombinant adeno-associated virus (rAAV) and lentivirus vectors; a pharmacology and toxicology core; and a coordinating center to manage program logistics and to provide regulatory and financial support to early phase clinical trials...
November 12, 2017: Human Gene Therapy. Clinical Development
https://www.readbyqxmd.com/read/29123521/good-manufacturing-practice-compliant-production-and-lot-release-of-ex-vivo-expanded-regulatory-t-cells-as-basis-for-treatment-of-patients-with-autoimmune-and-inflammatory-disorders
#4
Manuel Wiesinger, Diane Stoica, Susanne Roessner, Carmen Lorenz, Anika Fischer, Raja Atreya, Clemens F Neufert, Imke Atreya, Alexander Scheffold, Beatrice Schuler-Thurner, Markus F Neurath, Gerold Schuler, Caroline J Voskens
In recent years, the exploration of regulatory T cell (Treg)-based cellular therapy has become an attractive strategy to ameliorate inflammation and autoimmunity in various clinical settings. The main obstacle to the clinical application of Treg in human is their low number circulating in peripheral blood. Therefore, ex vivo expansion is inevitable. Moreover, isolation of Treg bears the risk of concurrent isolation of unwanted effector cells, which may trigger or deteriorate inflammation upon adoptive Treg transfer...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/29119484/clinically-amendable-defined-and-rapid-induction-of-human-brain-organoids-from-induced-pluripotent-stem-cells
#5
Eva Tomaskovic-Crook, Jeremy M Crook
Human brain organoids provide opportunities to produce three-dimensional (3D) brain-like tissues for biomedical research and translational drug discovery, toxicology, and tissue replacement. Here we describe a protocol for rapid and defined induction of brain organoids from human induced pluripotent stem cells (iPSCs), using commercially available culture and differentiation media and a cheap, easy to handle and clinically approved semisynthetic hydrogel. Importantly, the methodology is uncomplicated, well-defined, and reliable for reproducible and scalable organoid generation, and amendable to principles of current good laboratory practice (cGLP), with the potential for prospective adaptation to current good manufacturing practice (cGMP) toward clinical compliance...
November 9, 2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/29115976/gmp-production-of-purified-human-b-lymphocytes-for-the-adoptive-transfer-in-patients-after-allogeneic-hematopoietic-stem-cell-transplantation
#6
Hannes Tittlbach, Andrea Schneider, Julian Strobel, Robert Zimmermann, Stefanie Maas, Bernd Gebhardt, Georg Rauser, Michael Mach, Andreas Mackensen, Thomas H Winkler, Julia Winkler
BACKGROUND: We have recently shown that memory B cells from murine CMV immune donor animals adoptively transferred into immunodeficient mice were highly effective in protecting from a viral infection indicating a therapeutic potential of virus specific memory B cells. These preclinical data provided evidence that a cell-based strategy supporting the humoral immune response might be effective in a clinical setting of immunodeficiency after allogeneic hematopoietic stem cell transplantation...
November 7, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/29101419/fully-disposable-manufacturing-concepts-for-clinical-and-commercial-manufacturing-and-ballroom-concepts
#7
Berthold Boedeker, Adam Goldstein, Ekta Mahajan
The availability and use of pre-sterilized disposables has greatly changed the methods used in biopharmaceuticals development and production, particularly from mammalian cell culture. Nowadays, almost all process steps from cell expansion, fermentation, cell removal, and purification to formulation and storage of drug substances can be carried out in disposables, although there are still limitations with single-use technologies, particularly in the areas of pretesting and quality control of disposables, bag and connections standardization and qualification, extractables and leachables (E/L) validation, and dependency on individual vendors...
November 4, 2017: Advances in Biochemical Engineering/biotechnology
https://www.readbyqxmd.com/read/29096714/isolation-and-prolonged-expansion-of-oral-mesenchymal-stem-cells-under-clinical-grade-gmp-compliant-conditions-differentially-affects-stemness-properties
#8
Athina Bakopoulou, Danae Apatzidou, Eleni Aggelidou, Evangelia Gousopoulou, Gabriele Leyhausen, Joachim Volk, Aristeidis Kritis, Petros Koidis, Werner Geurtsen
BACKGROUND: Development of clinical-grade cell preparations is central to meeting the regulatory requirements for cellular therapies under good manufacturing practice-compliant (cGMP) conditions. Since addition of animal serum in culture media may compromise safe and efficient expansion of mesenchymal stem cells (MSCs) for clinical use, this study aimed to investigate the potential of two serum/xeno-free, cGMP culture systems to maintain long-term "stemness" of oral MSCs (dental pulp stem cells (DPSCs) and alveolar bone marrow MSCs (aBMMSCs)), compared to conventional serum-based expansion...
November 2, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/29078809/mesenchymal-stem-cells-for-cardiac-repair-are-the-actors-ready-for-the-clinical-scenario
#9
REVIEW
Santiago Roura, Carolina Gálvez-Montón, Clémentine Mirabel, Joaquim Vives, Antoni Bayes-Genis
For years, sufficient progress has been made in treating heart failure following myocardial infarction; however, the social and economic burdens and the costs to world health systems remain high. Moreover, treatment advances have not resolved the underlying problem of functional heart tissue loss. In this field of research, for years we have actively explored innovative biotherapies for cardiac repair. Here, we present a general, critical overview of our experience in using mesenchymal stem cells, derived from cardiac adipose tissue and umbilical cord blood, in a variety of cell therapy and tissue engineering approaches...
October 27, 2017: Stem Cell Research & Therapy
https://www.readbyqxmd.com/read/29076623/inflammation-stimulated-mesenchymal-stromal-cell-derived-extracellular-vesicles-attenuate-inflammation
#10
Matthew T Harting, Amit K Srivastava, Siqin Zhaorigetu, Henry Bair, Karthik S Prabhakara, Naama E Toledano Furman, Jody V Vykoukal, Katherine A Ruppert, Charles S Cox, Scott D Olson
Extracellular vesicles (EVs) secreted by mesenchymal stromal cells (MSCs) have been proposed to be a key mechanistic link in the therapeutic efficacy of cells in response to cellular injuries through paracrine effects. We hypothesize that inflammatory stimulation of MSCs results in the release of EVs that have greater anti-inflammatory effects. The present study evaluates the immunomodulatory abilities of EVs derived from inflammation-stimulated and naive MSCs (MSCEv(+) and MSCEv, respectively) isolated using a current Good Manufacturing Practice (cGMP)-compliant tangential flow filtration (TFF) system...
October 27, 2017: Stem Cells
https://www.readbyqxmd.com/read/29076098/good-manufacturing-practice-gmp-translation-of-advanced-cellular-therapeutics-lessons-for-the-manufacture-of-erythrocytes-as-medicinal-products
#11
Neil W A McGowan, John D M Campbell, Joanne C Mountford
Blood transfusion is a mainstay of modern medical practice. In many parts of the world the use of this life-saving therapy is hampered by issues of supply and the potential for transfusion transmitted infections. Accordingly, there are many studies seeking to find an alternative to donated red blood cells (RBCs) for transfusion, including large-scale production from adult and pluripotent stem cells, or erythroid cell lines. Translating basic studies, using any cell lineage, into protocols that are suitable for the generation of cellular therapies requires a wide range of biological and regulatory procedures to be put in place...
2018: Methods in Molecular Biology
https://www.readbyqxmd.com/read/29068066/parenteral-bilirubin-in-healthy-volunteers-a-reintroduction-in-translational-research
#12
Douwe Dekker, Mirrin J Dorresteijn, Marieke E B Welzen, Simone Timman, Peter Pickkers, David M Burger, Paul Smits, Frank A D T G Wagener, Frans G M Russel
AIM(S): Preclinical results suggest therapeutic potential of mild hyperbilirubinemia in T2DM and cardiovascular disease. Translational data are limited, because an appropriate bilirubin formulation for parenteral human use is lacking. Considering its use in both clinical practice and medical research in the past, we explored the feasibility to reintroduce parenteral bilirubin for translational experiments. METHODS: We developed a preparation method in accordance with good manufacturing practice and evaluated the parenteral applicability in healthy volunteers (n=8)...
October 25, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29066409/quality-challenges-associated-with-microbial-based-cleaning-products-from-the-industry-perspective
#13
Steve M Teasdale, Ali Kademi
Microbial-based cleaning products (MBCPs) continue to gain popularity in the market as environmentally friendly cleaners. The majority of these products contain spores of various Bacillus species. Although the microorganisms used in MBCPs are subject to regulation in Canada under the Canadian Environmental Protection Act, the products themselves are not. Unlike other types of microbial products such as probiotics and biopesticides, the use, manufacture and quality parameters of MBCPs in Canada and other countries are poorly defined and not specifically subject to any required standards...
October 21, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/29062835/toward-exosome-based-therapeutics-isolation-heterogeneity-and-fit-for-purpose-potency
#14
Gareth R Willis, Stella Kourembanas, S Alex Mitsialis
Exosomes are defined as submicron (30-150 nm), lipid bilayer-enclosed extracellular vesicles (EVs), specifically generated by the late endosomal compartment through fusion of multivesicular bodies with the plasma membrane. Produced by almost all cells, exosomes were originally considered to represent just a mechanism for jettisoning unwanted cellular moieties. Although this may be a major function in most cells, evolution has recruited the endosomal membrane-sorting pathway to duties beyond mere garbage disposal, one of the most notable examples being its cooption by retroviruses for the generation of Trojan virions...
2017: Frontiers in Cardiovascular Medicine
https://www.readbyqxmd.com/read/29058815/differentiation-of-msc-and-annulus-fibrosus-cells-on-genetically-engineered-silk-fleece-membrane-composites-enriched-for-gdf-6-or-tgf-%C3%AE-3
#15
Daniela A Frauchiger, Silvan R Heeb, Rahel D May, Michael Wöltje, Lorin M Benneker, Benjamin Gantenbein
Intervertebral disc (IVD) repair is a high-priority topic in our active and increasingly ageing society. Since a high number of people are affected by low back pain treatment options that are able to restore the biological function of the IVD are highly warranted. Here, we investigated whether the feasibility of genetically-engineered (GE)-silk from Bombyx mori containing specific growth factors to precondition human bone-marrow derived mesenchymal stem cells (hMSC) or to activate differentiated human annulus fibrosus cells (hAFC) prior transplantation or for direct repair on the IVD...
October 23, 2017: Journal of Orthopaedic Research: Official Publication of the Orthopaedic Research Society
https://www.readbyqxmd.com/read/29048795/-determination-of-residual-toluene-diisocyanate-in-sponge-bra-by-gas-chromatography
#16
Aixia Wang, Ping Ye, Nan Huang, Yan Chen, Xinggen Li
A gas chromatography (GC) with internal standard method was developed for the determination of residual toluene diisocyanate (TDI) in sponge bra. The samples were extracted with ethyl acetate dehydrated, and cleaned up with 0.22 μm microfiltration membrane. The residual toluene diisocyanate was separated on a DB-624 capillary column using temperature programming. The flame ionization detector (FID) was used at 250 ℃. The inlet temperature was 180 ℃ with nitrogen as carrier gas. The linear range was 10-200 mg/L (R(2)=0...
June 8, 2017: Se Pu, Chinese Journal of Chromatography
https://www.readbyqxmd.com/read/29022638/preparation-and-rgb-upconversion-optic-properties-of-transparent-anti-counterfeiting-films
#17
Weijing Yao, Qingyong Tian, Jun Liu, Qingwen Xue, Mengxiao Li, Li Liu, Qiang Lu, Wei Wu
Advanced anti-counterfeiting labels have aroused an intensive interest in packaging industry to avoid the serious issue of counterfeit. However, the preparation and cost of the existing labels associated with the drawbacks, including the complex and high-cost equipment, limit the protection of the authenticity of goods. Herein, we developed a series of anti-counterfeiting labels based on multicolor upconversion micro-particles (UCMPs) inks via straightforward and low-cost solutions, including spin-coating, stamping and screen printing...
October 26, 2017: Nanoscale
https://www.readbyqxmd.com/read/29017974/vectofusin-1-a-potent-peptidic-enhancer-of-viral-gene-transfer-forms-ph-dependent-%C3%AE-helical-nanofibrils-concentrating-viral-particles
#18
Louic S Vermeer, Loic Hamon, Alicia Schirer, Michel Schoup, Jérémie Cosette, Saliha Majdoul, David Pastré, Daniel Stockholm, Nathalie Holic, Petra Hellwig, Anne Galy, David Fenard, Burkhard Bechinger
Gene transfer using lentiviral vectors has therapeutic applications spanning from monogenic and infectious diseases to cancer. Such gene therapy has to be improved by enhancing the levels of viral infection of target cells and/or reducing the amount of lentivirus for greater safety and reduced costs. Vectofusin-1, a recently developed cationic amphipathic peptide with a pronounced capacity to enhance such viral transduction, strongly promotes the entry of several retroviral pseudotypes into target cells when added to the culture medium...
December 2017: Acta Biomaterialia
https://www.readbyqxmd.com/read/28991670/follow-on-products-for-treatment-of-multiple-sclerosis-in-latin-america-an-update
#19
REVIEW
Jorge Correale
Both proprietary and non-proprietary medicines are expected to undergo rigorous pre-approval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Non-proprietary (also known as copy or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower cost and thus increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy...
October 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28984641/prospects-for-adoptive-t-cell-therapy-for-invasive-fungal-disease
#20
Gloria Castellano-Gonzalez, Leighton E Clancy, David Gottlieb
PURPOSE OF REVIEW: Invasive fungal disease (IFD) is a cause of morbidity and mortality in allogeneic hematopoietic stem cell transplant (HSCT) recipients. As more potent broad-spectrum antifungal agents are used in prophylaxis, drug resistance and less common fungal species have increased in frequency. Here we review current treatments available for IFD and examine the potential for adoptive T-cell treatment to enhance current therapeutic choices in IFD. RECENT FINDINGS: There is growing evidence supporting the role of T cells as well as phagocytes in antifungal immunity...
October 3, 2017: Current Opinion in Infectious Diseases
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