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https://www.readbyqxmd.com/read/28811099/understanding-operational-system-differences-for-transfer-of-miniaturized-chromatography-column-data-using-simulations
#1
William R Keller, Steven T Evans, Gisela Ferreira, David Robbins, Steven M Cramer
In this paper, a simulation tool was employed to identify and appropriately incorporate differences between MiniColumns and benchtop column systems. It was first demonstrated that including multi-step gradients and fraction collection into the simulations resulted in improved agreement between simulated and experimental linear gradient profiles as well as calculated first moments in the MiniColumn experiments. Step elution experiments of binary mixtures (a monoclonal antibody and one of three model proteins) were then carried out to examine comparability of the MiniColumns to the benchtop system...
August 1, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28807912/safety-and-efficacy-of-mhaa4549a-a-broadly-neutralizing-monoclonal-antibody-in-a-human-influenza-a-challenge-model-a-phase-2-randomized-trial
#2
Jacqueline M McBride, Jeremy J Lim, Tracy Burgess, Rong Deng, Michael A Derby, Mauricio Maia, Priscilla Horn, Omer Siddiqui, Daniel Sheinson, Haiyin Chen-Harris, Elizabeth M Newton, Dimitri Fillos, Denise Nazzal, Carrie M Rosenberger, Maikke B Ohlson, Rob Lambkin-Williams, Hosnieh Fathi, Jeffrey M Harris, Jorge A Tavel
BACKGROUND: MHAA4549A, a human monoclonal antibody targeting the hemagglutinin stalk region of influenza A virus (IAV), is being developed as a therapeutic for patients hospitalized with severe IAV infection. Safety and efficacy of MHAA4549A were assessed in a randomized, double-blind, placebo-controlled, dose-ranging study in a human IAV-challenge model. METHODS: One hundred healthy volunteers were inoculated with A/Wisconsin/67/2005 (H3N2) IAV and, 24-36 hours later, administered a single intravenous dose of either placebo, MHAA4549A (400, 1200, or 3600 mg) or a standard oral dose of oseltamivir...
August 14, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28805662/clinical-and-immunological-responses-after-cd30-specific-chimeric-antigen-receptor-redirected-lymphocytes
#3
Carlos A Ramos, Brandon Ballard, Huimin Zhang, Olga Dakhova, Adrian P Gee, Zhuyong Mei, Mrinalini Bilgi, Meng-Fen Wu, Hao Liu, Bambi Grilley, Catherine M Bollard, Bill H Chang, Cliona M Rooney, Malcolm K Brenner, Helen E Heslop, Gianpietro Dotti, Barbara Savoldo
BACKGROUND: Targeting CD30 with monoclonal antibodies in Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL) has had profound clinical success. However, adverse events, mainly mediated by the toxin component of the conjugated antibodies, cause treatment discontinuation in many patients. Targeting CD30 with T cells expressing a CD30-specific chimeric antigen receptor (CAR) may reduce the side effects and augment antitumor activity. METHODS: We conducted a phase I dose escalation study in which 9 patients with relapsed/refractory HL or ALCL were infused with autologous T cells that were gene-modified with a retroviral vector to express the CD30-specific CAR (CD30...
August 14, 2017: Journal of Clinical Investigation
https://www.readbyqxmd.com/read/28795553/-chronic-demyelinating-polyradiculoneuropathy-revealing-a-solitary-plasmacytoma-of-the-right-iliac-bone
#4
J Oumerzouk, A Bourazza
Solitary bone plasmacytoma (pso) is a rare tumor, made of malignant plasma cells observed in a single bone, and without systemic proliferation. We report the case of a 33 year-old man who was admitted with chronic demyelinating sensorimotor polyneuropathy. Immunoelectrophoresis with immunofixation of serum proteins showed a monoclonal peak igg with lambda light chain and the workup was in favour of right hipbone secreting solitary plasmacytoma. The patient was treated with radiotherapy and steroids, and the evolution has been marked by a partial recovery of the motor deficit...
July 2017: Revue Médicale de Liège
https://www.readbyqxmd.com/read/28769797/over-expression-of-a-codon-optimized-yeast-cytosolic-pyruvate-carboxylase-pyc2-in-cho-cells-for-an-augmented-lactate-metabolism
#5
Sanjeev K Gupta, Ankit Sharma, Hiralal Kushwaha, Pratyoosh Shukla
Monoclonal antibodies are the most demanding biotherapeutic drugs now a days used for the cure of various critical illnesses. Chinese hamster ovary (CHO) cells are one of the main hosts used for the large scale production of these antibodies. However, the cell line and production processes are the key factors to determine the cost and affordability of these antibodies. The metabolic waste lactic acid and ammonium are accumulated during a cell culture process and adversely affects productivity as well as product quality...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28733224/celf1-preferentially-binds-to-exon-intron-boundary-and-regulates-alternative-splicing-in-hela-cells
#6
Heng Xia, Dong Chen, Qijia Wu, Gang Wu, Yanhong Zhou, Yi Zhang, Libin Zhang
The current RIP-seq approach has been developed for the identification of genome-wide interaction between RNA binding protein (RBP) and the bound RNA transcripts, but still rarely for identifying its binding sites. In this study, we performed RIP-seq experiments in HeLa cells using a monoclonal antibody against CELF1. Mapping of the RIP-seq reads showed a biased distribution at the 3'UTR and intronic regions. A total of 15,285 and 1384 CELF1-specific sense and antisense peaks were identified using the ABLIRC software tool...
July 19, 2017: Biochimica et Biophysica Acta
https://www.readbyqxmd.com/read/28731622/mechanistic-modeling-based-pat-implementation-for-ion-exchange-process-chromatography-of-charge-variants-of-monoclonal-antibody-products
#7
Vijesh Kumar, Anurag S Rathore
Process chromatography is typically used to remove product related impurities and variants that have very similar physicochemical properties to the product. Baseline separation may not be achieved in most cases due to high protein loading and thus, pooling of the elution peak can be challenging for maximizing yield and achieving consistency in product quality. Batch-to-batch variability in quality of the feed material also occurs in commercial manufacturing. Mechanistic modeling of process chromatography, though non-trivial, can be an enabler for implementation of Process Analytical Technology...
July 21, 2017: Biotechnology Journal
https://www.readbyqxmd.com/read/28714899/electrochemical-flow-elisa-for-rapid-and-sensitive-determination-of-microcystin-lr-using-automated-sequential-injection-system
#8
Lesedi Lebogang, Jongjit Jantra, Martin Hedström, Bo Mattiasson
An amperometric immunoanalysis system based on monoclonal antibodies immobilized on Sepharose beads and packed into a micro-immunocolumn was developed for the quantification of microcystin-LR. Microcystin-LR (MCLR) was used as a reference microcystin variant. Inside the immunocolumn, free microcystins and microcystin-horseradish peroxidase (tracer) were sequentially captured by the immobilized antibodies, and the detection was performed electrochemically using Super AquaBlue ELISA substrate 2,2'-azinobis(3-ethylbenzothiazoline-sulfonic acid) (ABTS)...
July 16, 2017: Sensors
https://www.readbyqxmd.com/read/28694087/a-mathematical-model-of-a-recombinant-humanized-anti-cocaine-monoclonal-antibody-s-effects-on-cocaine-pharmacokinetics-in-mice
#9
Hanna N Wetzel, Tongli Zhang, Andrew B Norman
AIMS: A recombinant humanized anti-cocaine monoclonal antibody (mAb), h2E2, is at an advanced stage of pre-clinical development as an immunotherapy for cocaine abuse. It is hypothesized that h2E2 binds to and sequesters cocaine in the blood. MAIN METHODS: A three-compartment model of the effects of h2E2 on cocaine's distribution was constructed. The model assumes that h2E2 binds to cocaine and that the h2E2-cocaine complex does not enter the brain but distributes between the central and peripheral compartments...
September 1, 2017: Life Sciences
https://www.readbyqxmd.com/read/28687496/romosozumab-increases-bone-mineral-density-in-postmenopausal-japanese-women-with-osteoporosis-a-phase-2-study
#10
Hideaki Ishibashi, Daria B Crittenden, Akimitsu Miyauchi, Cesar Libanati, Judy Maddox, Michelle Fan, Li Chen, Andreas Grauer
BACKGROUND: Romosozumab is a monoclonal antibody that inhibits sclerostin and rapidly increases bone mineral density (BMD) through a dual effect on bone by increasing bone formation and decreasing bone resorption, as shown in a global phase 2 study in postmenopausal women with low bone mass. Here, we report the key results of a phase 2, double-blind, placebo-controlled, dose-ranging study to assess the efficacy and safety of romosozumab in postmenopausal Japanese women with osteoporosis...
July 5, 2017: Bone
https://www.readbyqxmd.com/read/28664195/partial-exhaustion-of-cd8-t-cells-and-clinical-response-to-teplizumab-in-new-onset-type-1-diabetes
#11
S Alice Long, Jerill Thorpe, Hannah A DeBerg, Vivian Gersuk, James Eddy, Kristina M Harris, Mario Ehlers, Kevan C Herold, Gerald T Nepom, Peter S Linsley
Biologic treatment of T1D typically results in transient stabilization of C-peptide levels (a surrogate for endogenous insulin secretion) in some patients, followed by progression at the same rate as in untreated control groups. Here, we used integrated systems biology and flow cytometry approaches with clinical trial blood samples to elucidate pathways associated with C-peptide stabilization in T1D subjects treated with the anti-CD3 monoclonal antibody teplizumab. We identified a population of CD8 T cells that accumulated in subjects with the best response to treatment (responders) and showed that these cells phenotypically resembled exhausted T cells by expressing high levels of the transcription factor EOMES, effector molecules, and multiple inhibitory receptors (IRs), including TIGIT and KLRG1...
November 2016: Science Immunology
https://www.readbyqxmd.com/read/28638738/activation-of-the-fcgammareceptoriiia-on-human-natural-killer-cells-leads-to-increased-expression-of-functional-interleukin-21-receptor
#12
Elizabeth L McMichael, Nicholas B Courtney, Megan C Duggan, Robert Wesolowski, Dionisia Quiroga, Sri Vidya Kondadasula, Lakhvir S Atwal, Neela Bhave, Eric Luedke, Alena Cristina Jaime-Ramirez, Amanda R Campbell, Xiaokui Mo, John C Byrd, William E Carson Iii
Natural killer (NK) cells are innate immune effector cells that play a crucial role in immune surveillance and the destruction of cancer cells. NK cells express a low-affinity receptor for the Fc or constant region of immunoglobulin G (FcγRIIIa) and multiple cytokine receptors that respond to antibody-coated targets and cytokines in the tumor microenvironment. In the present work, microarray gene expression analysis revealed that the IL-21 receptor (IL-21R) was strongly upregulated following FcR stimulation...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/28613884/carbohydrate-polypeptide-contacts-in-the-antibody-receptor-cd16a-identified-through-solution-nmr-spectroscopy
#13
Ganesh P Subedi, Daniel J Falconer, Adam W Barb
Asparagine-linked carbohydrates (N-glycans) are common modifications of eukaryotic proteins that confer multiple properties, including the essential stabilization of therapeutic monoclonal antibodies. Here we present a rapid and efficient strategy for identifying N-glycans that contact polypeptide residues and apply the method to profile the five N-glycans attached to the human antibody receptor CD16A (Fc γ receptor IIIA). Human embryonic kidney 293S cells expressed CD16A with (13)CU-labeled N-glycans using standard protein expression techniques and medium supplemented with 3 g/L [(13)CU]glucose...
June 27, 2017: Biochemistry
https://www.readbyqxmd.com/read/28594458/concizumab-an-anti-tissue-factor-pathway-inhibitor-antibody-induces-increased-thrombin-generation-in-plasma-from-haemophilia-patients-and-healthy-subjects-measured-by-the-thrombin-generation-assay
#14
E K Waters, J Sigh, U Friedrich, I Hilden, B B Sørensen
AIMS: Concizumab, a humanized monoclonal antibody against tissue factor pathway inhibitor (TFPI), is being developed as a subcutaneously (s.c.) administered treatment for haemophilia. It demonstrated a concentration-dependent procoagulant effect in functional TFPI assays; however, global haemostatic assays, such as the thrombin generation assay (TGA), offer a more complete picture of coagulation. We investigated how concizumab affects thrombin generation following ex vivo spiking in plasma from haemophilia patients using the TGA, and if the assay can detect the effect of multiple s...
June 8, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28587251/pharmacokinetics-and-tissue-distribution-kinetics-of-puerarin-in-rats-using-indirect-competitive-elisa
#15
Hui Kong, Xueqian Wang, Rongfeng Shi, Yan Zhao, Jinjun Cheng, Xin Yan, Xiaoman Liu, Yongzhi Wang, Meiling Zhang, Qingguo Wang, Huihua Qu
Puerarin (PUE) is a compound isolated from the roots of Pueraria lobata. We studied the pharmacokinetics and tissue distribution kinetics of PUE in Sprague-Dawley rats following intraperitoneal administration of three concentrations. Indirect competitive ELISA based on an anti-PUE monoclonal antibody was used to determine the concentration of PUE in the blood, heart, liver, spleen, lung, kidney, hippocampus, cerebral cortex, and striatum. The plasma and tissue distribution kinetic characteristics following a single injection of PUE (20, 40 and 80 mg/kg) were calculated using a non-compartment model...
June 5, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28540859/case-report-serological-testing-interference-of-daratumumab-anti-cd38-therapy-in-multiple-myeloma
#16
Élodie Rabut, Annabelle Castro-Fernandez, Virginie Le Gall, Nihad Meknache
We report the case of a 54 years old patient monitored for a monoclonal IgG kappa light chain refractory relapsed multiple myeloma and receiving daratumumab immunotherapy. Daratumumab (DARA), a monoclonal anti-CD38 antibody, belongs to the new generation of immunotherapy in refractory relapse multiple myeloma which the medical pathologist should be aware of to avoid misinterpretation of biological tests performed for patients followed for this disease. By its IgG1K humanized monoclonal antibody backbone, DARA interferes in both serum protein electrophoresis and immunofixation by the presence of an alternate IgGK monoclonal peak, leading to a possible difficulty to assess treatment's response in monoclonal IgG kappa light chain myeloma...
June 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28539438/discovery-of-a-prefusion-respiratory-syncytial-virus-f-specific-monoclonal-antibody-that-provides-greater-in-vivo-protection-than-the-murine-precursor-of-palivizumab
#17
Min Zhao, Zi-Zheng Zheng, Man Chen, Kayvon Modjarrad, Wei Zhang, Lu-Ting Zhan, Jian-Li Cao, Yong-Peng Sun, Jason S McLellan, Barney S Graham, Ning-Shao Xia
Palivizumab, a humanized murine monoclonal antibody that recognizes antigenic site II on both the prefusion (pre-F) and postfusion (post-F) conformations of the respiratory syncytial virus (RSV) F glycoprotein, is the only prophylactic agent approved for use for the treatment of RSV infection. However, its relatively low neutralizing potency and high cost have limited its use to a restricted population of infants at high risk of severe disease. Previously, we isolated a high-potency neutralizing antibody, 5C4, that specifically recognizes antigenic site Ø at the apex of the pre-F protein trimer...
August 1, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28527055/cluster-headache-present-and-future-therapy
#18
Massimo Leone, Alessandro Giustiniani, Alberto Proietti Cecchini
Cluster headache is characterized by severe, unilateral headache attacks of orbital, supraorbital or temporal pain lasting 15-180 min accompanied by ipsilateral lacrimation, rhinorrhea and other cranial autonomic manifestations. Cluster headache attacks need fast-acting abortive agents because the pain peaks very quickly; sumatriptan injection is the gold standard acute treatment. First-line preventative drugs include verapamil and carbolithium. Other drugs demonstrated effective in open trials include topiramate, valproic acid, gabapentin and others...
May 2017: Neurological Sciences
https://www.readbyqxmd.com/read/28490046/rapid-homogeneous-immunoassay-to-quantify-gemcitabine-in-plasma-for-therapeutic-drug-monitoring
#19
Daniel Kozo, Matt W Ross, Justin Jarrah, Michael Barrett, Rebecca L Harney, Jodi B Courtney, Irina Baburina, Julianne L Holleran, Jan H Beumer, Godefridus J Peters, Richard J Honeywell, Salvatore J Salamone
BACKGROUND: Gemcitabine (2',2'-difluoro-2'-deoxycytidine) is a nucleoside analog used as a single agent and in combination regimens for the treatment of a variety of solid tumors. Several studies have shown a relationship between gemcitabine peak plasma concentration (Cmax) and hematological toxicity. An immunoassay for gemcitabine in plasma was developed and validated to facilitate therapeutic drug monitoring (TDM) by providing an economical, robust method for automated chemistry analyzers...
June 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28482593/electrochemical-immunosensor-based-on-poly-3-4-ethylenedioxythiophene-modified-with-gold-nanoparticle-to-detect-aflatoxin-b1
#20
Arati Sharma, A Kumar, Raju Khan
Gold nanoparticles (Au-NPs) functionalized Poly (3,4-ethylenedioxythiophene) (PEDOT) bioelectrodes were fabricated layer by layer deposition on ITO electrode for detection of aflatoxin B1. The monoclonal anti-aflatoxin antibodies (Anti-AFB1) were immobilized over the surface of PEDOT/Au-NPs/ITO using EDC/NHS coupling. The surface morphology and characteristics of the modified electrodes were investigated by scanning electron microscope and contact angle measurements. The electrochemical analysis of the fabricated immunoelectrode and the immobilization of the antibodies have been evaluated and confirmed by performing Cyclic Voltammetry (CV), Electrochemical Impedance Spectroscopy (EIS) and Fourier Transform Infrared Spectroscopy (FTIR)...
July 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
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