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https://www.readbyqxmd.com/read/28436003/bio-coda-a-new-analysis-class-to-ensure-accurate-and-precise-monoclonal-antibody-cqa-estimation-and-control
#1
Anthony Lonardo, Babita Saxena Parekh, Arvind Srivastava
Monoclonal antibody production processes control Critical Quality Attributes (CQAs) which are the measures that provide proof of a product's identity and quality. Critical decisions rely on the accuracy and precision of these measures, as well as their appropriate statistical treatment. Many measures require special attention. For example the charge heterogeneity CQA measured by Ionic Exchange Chromatography (IEC) reports proportions or percentages of the total integrated peak area of known species. Since proportions sum to a constant (1 or 100%) they fall into a special class of data called compositional data which have a unit sum constraint and therefore an inherent correlation...
April 24, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28433716/development-of-a-monoclonal-antibody-against-the-cd3%C3%AE%C2%B5-of-olive-flounder-paralichthys-olivaceus-and-its-application-in-evaluating-immune-response-related-to-cd3%C3%AE%C2%B5
#2
Jae Wook Jung, Jung Seok Lee, Young Rim Kim, Se Pyeong Im, Si Won Kim, Jassy Mary S Lazarte, Jaesung Kim, Kim D Thompson, Jong Pyo Suh, Tae Sung Jung
The T cell receptor (TCR) is the binding site of antigen and is responsible for specifically activating the adaptive immune response. CD3, an essential component of the CD3-TCR complex, is known to be composed of γδ and ε chains in teleost. However, there are few monoclonal antibodies (mAb) available to identify these molecules on T cells, so we aimed to produce a mAb against CD3ε to improve our understanding of T cell immune response in olive flounder (Paralichthys olivaceus). CD3ε recombinant protein was expressed in yeast, the expression of which was confirmed by SDS-PAGE, MALDI-TOF/TOF MS and Western blot analysis...
April 19, 2017: Fish & Shellfish Immunology
https://www.readbyqxmd.com/read/28431324/achievable-separation-performance-and-analysis-time-in-current-liquid-chromatographic-practice-for-monoclonal-antibody-separations
#3
Szabolcs Fekete, Jean-Luc Veuthey, Davy Guillarme
The separation performance of a chromatographic system is often described in terms of column efficiency and peak capacity. Thanks to the new developments in column technology over the past few years, the achievable peak capacity drastically improved and the analysis time can be significantly shortened. Indeed, highly efficient wide-pore reversed-phase (RPLC) materials packed with small fully porous and superficially porous particles can be successfully used for the analytical characterization of therapeutic proteins...
April 12, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28426914/recommended-dose-of-idarucizumab-may-not-always-be-sufficient-for-sustained-reversal-of-dabigatran
#4
Alexander Simon, Hans Domanovits, Cihan Ay, Gürkan Sengölge, Jerrold H Lewy, Alexander O Spiel
Idarucizumab is a monoclonal antibody fragment designed for reversing the anticoagulant effects of dabigatran. Administration is recommended as two intravenous boluses of 2.5 g within 15 minutes of each other or as a single 5 g bolus. However, in certain situations a second dose of the drug could be necessary. We report the case of a 77-year old man, treated with dabigatran for paroxysmal atrial fibrillation. He presented at our department with acute renal failure, concomitant massive dabigatran accumulation, and subsequent acute gastrointestinal bleeding...
April 20, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28402653/host-cell-protein-profiling-by-targeted-and-untargeted-analysis-of-data-independent-acquisition-mass-spectrometry-data-with-parallel-reaction-monitoring-verification
#5
Simion Kreimer, Yuanwei Gao, Somak Ray, Mi Jin, Zhijun Tan, Nesredin A Mussa, Li Tao, Zhengjian Li, Alexander R Ivanov, Barry L Karger
Host cell proteins (HCPs) are process-related impurities of biopharmaceuticals that remain at trace levels despite multiple stages of downstream purification. Currently, there is interest in implementing LC-MS in biopharmaceutical HCP profiling alongside conventional ELISA, because individual species can be identified and quantitated. Conventional data-dependent LC-MS is hampered by the low concentration of HCP-derived peptides, which are 5-6 orders of magnitude less abundant than the biopharmaceutical-derived peptides...
April 12, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28380679/extracellular-assembly-of-the-elastin-cable-line-element-in-the-developing-lung
#6
Cristian D Valenzuela, Willi L Wagner, Robert D Bennett, Alexandra B Ysasi, Janeil M Belle, Karin Molter, Beate K Straub, Dong Wang, Zi Chen, Maximilian Ackermann, Akira Tsuda, Steven J Mentzer
In the normal lung, a dominant structural element is an elastic "line element" that originates in the central bronchi and inserts into the distal airspaces. Despite its structural importance, the process that leads to development of the cable line element is unknown. To investigate the morphologic events contributing to its development, we used optical clearing methods to examine the postnatal rat lung. An unexpected finding was numerous spheres, with a median diameter of 1-2 µm, within the primary septa of the rat lung...
April 5, 2017: Anatomical Record: Advances in Integrative Anatomy and Evolutionary Biology
https://www.readbyqxmd.com/read/28379786/unbiased-in-depth-characterization-of-cex-fractions-from-a-stressed-monoclonal-antibody-by-mass-spectrometry
#7
François Griaud, Blandine Denefeld, Manuel Lang, Héloïse Hensinger, Peter Haberl, Matthias Berg
Characterization of charge-based variants by mass spectrometry (MS) is required for the analytical development of a new biological entity and its marketing approval by health authorities. However, standard peak-based data analysis approaches are time-consuming and biased towards the detection, identification, and quantification of main variants only. The aim of this study was to characterize in-depth acidic and basic species of a stressed IgG1 monoclonal antibody using comprehensive and unbiased MS data evaluation tools...
April 5, 2017: MAbs
https://www.readbyqxmd.com/read/28368743/population-pharmacokinetics-analysis-of-vrc01-an-hiv-1-broadly-neutralizing-monoclonal-antibody-in-healthy-adults
#8
Yunda Huang, Lily Zhang, Julie Ledgerwood, Nicole Grunenberg, Robert Bailer, Abby Isaacs, Kelly Seaton, Kenneth H Mayer, Edmund Capparelli, Larry Corey, Peter B Gilbert
The monoclonal antibody VRC01 targets the CD4 binding site of the human immunodeficiency virus (HIV)-1 envelope. In the clinical study HVTN 104 (NCT02165267), 84 HIV-uninfected adults received multiple-dose intravenous (IV) VRC01 (10, 20, 30 or 40 mg/kg) every 4 or 8 weeks or subcutaneous (SC) VRC01 (5 mg/kg) every 2 weeks, and were followed for 32 weeks. We conducted a population pharmacokinetics (popPK) analysis based on 1117 VRC01 serum concentrations using a 2-compartment PK model with first-order elimination; for SC VRC01 a depot compartment with a first-order absorption rate constant was also included...
April 3, 2017: MAbs
https://www.readbyqxmd.com/read/28346883/identification-and-characterization-of-a-thermally-cleaved-fragment-of-monoclonal-antibody-a-detected-by-sodium-dodecyl-sulfate-capillary-gel-electrophoresis
#9
Kei Kubota, Naoki Kobayashi, Masayuki Yabuta, Motomu Ohara, Toyohiro Naito, Takuya Kubo, Koji Otsuka
This report describes a novel, comprehensive approach to identifying a fragment peak of monoclonal antibody-A (mAb-A), detected by sodium dodecyl sulfate-capillary gel electrophoresis (SDS-cGE). The fragment migrated close to the internal standard (10kDa marker) of SDS-cGE and increased about 0.5% under a 25°C condition for 6 months. Generally, identification of fragments observed in SDS-cGE is challenging to carry out due to the difficulty of collecting analytical amounts of fractionations from the capillary...
June 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28341808/protein-coalation-a-redox-regulated-protein-modification-by-coenzyme-ain-mammalian-cells
#10
Yugo Tsuchiya, Sew Peak-Chew, Clare Newell, Sheritta Miller-Aidoo, Sriyash Mangal, Alexander Zhyvoloup, Jovana Baković, Oksana Malanchuk, Gonçalo Pereira, Vassilios Kotiadis, Gyorgy Szabadkai, Michael Duchen, Mark Campbell, Sergio Rodriguez Cuenca, Antonio Vidal-Puig, Andrew James, Michael P Murphy, Valeriy Filonenko, Mark Skehel, Ivan Gout
Coenzyme A (CoA) is an obligatory cofactor in all branches of life. CoA and its derivatives are involved in major metabolic pathways, allosteric interactions and the regulation of gene expression. Abnormal biosynthesis and homeostasis of CoA and its derivatives have been associated with various human pathologies, including cancer, diabetes and neurodegeneration. Using an anti-CoA monoclonal antibody and mass spectrometry we identified a wide range of cellular proteins which are modified by covalent attachment of CoA to cysteine thiols (CoAlation)...
March 24, 2017: Biochemical Journal
https://www.readbyqxmd.com/read/28327200/a-first-in-human-phase-1-study-of-a-hepcidin-monoclonal-antibody-ly2787106-in-cancer-associated-anemia
#11
Saroj Vadhan-Raj, Rafat Abonour, Jonathan W Goldman, David A Smith, Christopher A Slapak, Robert L Ilaria, Ramon V Tiu, Xuejing Wang, Sophie Callies, Joanne Cox, Jay L Tuttle, Yiu-Keung Lau, Eric J Roeland
BACKGROUND: Hepcidin plays a central role in iron homeostasis and erythropoiesis. Neutralizing hepcidin with a monoclonal antibody (mAb) may prevent ferroportin internalization, restore iron efflux from cells, and allow transferrin-mediated iron transport to the bone marrow. This multicenter, phase 1 study evaluated the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of a fully humanized mAb (LY2787106) with high affinity for hepcidin in cancer patients with anemia...
March 21, 2017: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/28274724/characterization-of-succinimide-stability-during-trypsin-digestion-for-lc-ms-analysis
#12
Christine Nowak, Gomathinayagam Ponniah, Alyssa Neill, Hongcheng Liu
LC-MS peptide mapping is the most commonly used method to analyze protein modifications. The proteins are generally digested using trypsin at a slightly basic pH at 37 °C from several hours to overnight. Assay-induced artifacts can be generated during this procedure, potentially causing false-positive or false-negative results for a given modification. Unfortunately, for the analysis of succinimide, both false-negative and false-positive results can be generated within the same procedure. This study evaluates the stability of succinimide during the peptide mapping procedure and has demonstrated that up to 13% of pre-existing succinimide was lost during a 4 h trypsin digestion at pH 5...
March 6, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/28259457/optimization-of-ion-exchange-sigmoidal-gradients-using-hybrid-models-implementation-of-quality-by-design-in-analytical-method-development
#13
Varsha S Joshi, Vijesh Kumar, Anurag S Rathore
Thorough product understanding is one of the basic tenets for successful implementation of Quality by Design (QbD). Complexity encountered in analytical characterization of biotech therapeutics such as monoclonal antibodies (mAbs) requires novel, simpler, and generic approaches towards product characterization. This paper presents a methodology for implementation of QbD for analytical method development. Optimization of an analytical cation exchange high performance liquid chromatography (CEX-HPLC) method utilizing a sigmoidal gradient has been performed using a hybrid mechanistic model that is based on Design of experiment (DOE) based studies...
March 31, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28242439/kv3-1-kv3-2-channel-positive-modulators-enable-faster-activating-kinetics-and-increase-firing-frequency-in-fast-spiking-gabaergic-interneurons
#14
Kim Boddum, Charlotte Hougaard, Julie Xiao-Ying Lin, Nadia Lybøl von Schoubye, Henrik Sindal Jensen, Morten Grunnet, Thomas Jespersen
Due to their fast kinetic properties, Kv3.1 voltage gated potassium channels are important in setting and controlling firing frequency in neurons and pivotal in generating high frequency firing of interneurons. Pharmacological activation of Kv3.1 channels may possess therapeutic potential for treatment of epilepsy, hearing disorders, schizophrenia and cognitive impairments. Here we thoroughly investigate the selectivity and positive modulation of the two small molecules, EX15 and RE01, on Kv3 channels. Selectivity studies, conducted in Xenopus laevis oocytes confirmed a positive modulatory effect of the two compounds on Kv3...
February 24, 2017: Neuropharmacology
https://www.readbyqxmd.com/read/28224631/development-and-application-of-monoclonal-antibodies-against-igm-of-black-rockfish-sebastes-schlegeli
#15
W Zhang, X Q Tang, X Z Sheng, J Xing, W B Zhan
Monoclonal antibodies (mAbs) against black rockfish Sebastes schlegeli serum immunoglobulin M (IgM) were developed, which showed a specific reaction with the heavy chain of S. schlegeli IgM in Western blotting and with surface IgM positive (sIgM(+) ) lymphocytes in indirect immunofluorescence. mAb 2A6 was employed to investigate the antibody and sIgM(+) lymphocyte responses of S. schlegeli injected with inactivated Edwardsiella tarda, by ELISA and flow cytometry. Compared with controls, the level of specific antibodies and the percentage of sIgM(+) lymphocytes both increased in the immunized fish and simultaneously reached their peaks at day 35 after immunization...
April 2017: Journal of Fish Biology
https://www.readbyqxmd.com/read/28223726/dendritic-cells-engineered-to-secrete-anti-dcr3-antibody-augment-cytotoxic-t-lymphocyte-response-against-pancreatic-cancer-in-vitro
#16
Jiang Chen, Xiao-Zhong Guo, Hong-Yu Li, Jia-Jun Zhao, Wen-Da Xu
AIM: To investigate the enhanced cytotoxic T lymphocyte responses against pancreatic cancer (PC) in vitro induced by dendritic cells (DCs) engineered to secrete anti-DcR3 monoclonal antibody (mAb). METHODS: DCs, T lymphocytes and primary PC cells were obtained from PC patients. DCs were transfected with a designed humanized anti-DcR3 monoclonal antibody heavy and light chain mRNA and/or total tumor RNA (DC-tumor-anti-DcR3 RNA or DC-total tumor RNA) by using electroporation technology...
February 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28209962/characterization-of-celiac-disease-related-oat-proteins-bases-for-the-development-of-high-quality-oat-varieties-suitable-for-celiac-patients
#17
María J Giménez, Ana Real, M Dolores García-Molina, Carolina Sousa, Francisco Barro
Some studies have suggested that the immunogenicity of oats depends on the cultivar. RP-HPLC has been proposed as a useful technique to select varieties of oats with reduced immunogenicity. The aim of this study was to identify both the avenin protein patterns associated with low gluten content and the available variability for the development of new non-toxic oat cultivars. The peaks of alcohol-soluble avenins of a collection of landraces and cultivars of oats have been characterized based on the RP-HPLC elution times...
February 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28178596/automated-2d-hplc-method-for-characterization-of-protein-aggregation-with-in-line-fraction-collection-device
#18
Abasha Williams, Erik K Read, Cyrus D Agarabi, Scott Lute, Kurt A Brorson
Monoclonal antibodies are mainly produced by mammalian cell culture, which due to its complexity, results in a wide range of product variants/isoforms. With the growing implementation of Quality by Design (QbD) and Process Analytical Technology (PAT) in drug manufacturing, monitoring and controlling quality attributes within a predefined range during manufacturing may provide added consistency to product quality. To implement these concepts, more robust analytical tools could reduce the time needed for monitoring quality attributes during upstream processing...
January 25, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28153228/a-novel-microchip-electrophoresis-based-chemiluminescence-immunoassay-for-the-detection-of-alpha-fetoprotein-in-human-serum
#19
Jingwen Liu, Jingjin Zhao, Shuting Li, Liangliang Zhang, Yong Huang, Shulin Zhao
A sensitive immunoassay method based on microchip electrophoresis chemiluminescence (MCE-CL) detection technology was developed for the detection of tumor marker alpha-fetoprotein (AFP). This method adopts the non-competitive immunoassay mode, and was conducted after AFP reacted with excessive horseradish peroxidase (HRP) labeled monoclonal antibody. The extreme pH value was adopted in the electrophoresis buffer solution. The use of brij 35 as an additive of electrophoresis buffer increased dramatically the resolution (Rs) and the reproducibility of the analysis...
April 1, 2017: Talanta
https://www.readbyqxmd.com/read/28112125/systemic-administration-of-an-anti-tumor-necrosis-factor-alpha-monoclonal-antibody-protects-against-endotoxin-induced-uveitis-in-rats
#20
Qingman Ge, Shaocheng Wang, Yuezhong Zheng
OBJECTIVE: This study was to evaluate the effect of systemic injection of an anti-tumor necrosis factor alpha (TNF-α) monoclonal antibody (mAb) on endotoxin-induced uveitis (EIU). MATERIALS AND METHODS: Fifty-six male Wistar rats (6-8 weeks old) were randomly divided into three groups: EIU, anti-TNF-α mAb + EIU, and control. EIU was induced by injecting Escherichia coli O55:B5 lipopolysaccharide (LPS) into the hind footpad of the rats (150 μg/rat). The anti-TNF-α mAb (1 μg/kg) was administrated 30 min before LPS injection through one-time intravenous injection...
December 2016: Indian Journal of Ophthalmology
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