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Monoclonal peak

N Cilla, M Vercruyssen, L Ameye, M Paesmans, A de Wind, P Heimann, N Meuleman, D Bron
INTRODUCTION: An IgM monoclonal gammopathy points to a diagnosis of Waldenstrom's Macroglobulinemia. Other B lymphoproliferatives disorders should be ruled out but the limits are sometimes difficult to define. The discovery of the L265P mutation of the MYD88 gene simplified potentially the situation. POPULATION AND METHODS: 383 patients of the Jules Bordet Institute with an IgM level above 2 g/L were reviewed. For the 49 who had a monoclonal peak, we analysed the underlying pathology in termes of general, clinical and biological characteristics...
May 30, 2018: Revue Médicale de Bruxelles
Pratima Chowdary
Replacement therapy with missing factor (F) VIII or IX in haemophilia patients for bleed management and preventative treatment or prophylaxis is standard of care. Restoration of thrombin generation through novel mechanisms has become the focus of innovation to overcome limitations imposed by protein replacement therapy. Tissue factor pathway inhibitor (TFPI) is a multivalent Kunitz-type serine protease inhibitor that regulates tissue factor (TF)-induced coagulation through a FXa-dependent feedback inhibition of the TF...
May 29, 2018: Drugs
Rüdiger Nave, Stefan Jodl, Anja Hoffmann, Isabella Gashaw, Frank Zollmann, Matthias Berse, Joachim Höchel, Jörn Krätzschmar, Beate Rohde
BAY 1158061 is a potent monoclonal prolactin (PRL) receptor antibody, blocking PRL receptor (PRLR)-mediated signaling in a noncompetitive manner, which was tested in a randomized, placebo-controlled multiple dose study in postmenopausal women. The objective was to investigate safety, tolerability, pharmacokinetic characteristics, and effects of BAY 1158061 on serum PRL level. The study consisted of 4 parallel groups receiving up to 3 subcutaneous (sc) administrations of BAY 1158061 or placebo in 2 different dosing regimens...
January 1, 2018: Reproductive Sciences
Antonio Martínez-Ortega, Agustín Herrera, Antonio Salmerón-García, José Cabeza, Luis Cuadros-Rodríguez, Natalia Navas
The aim of the present study was to develop suitable and reliable method for quantification three of the most worldwide used therapeutic monoclonal antibodies (mAbs) -bevazizumab (BVZ), infliximab (INF) and trastuzumab (TTZ)- to be used in long-term stability studies. Reverse phase (RP) was selected by its greater sensibility and reproducibility comparing with other chromatographic modes. Then a high performance liquid chromatography with diode array detection (RP)HPLC/DAD method was checked. Since the three mAbs represent the active ingredient in the medicines in which they are formulated, the selected method was validated for each one in accordance with the International Conference on Harmonization (ICH) guidelines for pharmaceuticals for human use...
May 21, 2018: International Journal of Biological Macromolecules
Suekyeung Kim, Hyung-Seok Yang, Anbok Lee, Sun Young Cho
BACKGROUND: Serum and urinary protein electrophoresis play an important role in the identification of monoclonal gammopathy. Recently, capillary electrophoresis (CE) has been adapted in many clinical laboratories because of several advantages such as short turnaround time, automation, and high reproducibility. However, there have been unsolved concerns for the concordance between conventional gel and automated capillary electrophoresis methods for protein separation in clinical specimens...
March 1, 2018: Clinical Laboratory
Catalin Doneanu, Jing Fang, Yun Alelyunas, Ying Qing Yu, Mark Wrona, Weibin Chen
The analysis of low-level (1-100 ppm) protein impurities (e.g., host-cell proteins (HCPs)) in protein biotherapeutics is a challenging assay requiring high sensitivity and a wide dynamic range. Mass spectrometry-based quantification assays for proteins typically involve protein digestion followed by the selective reaction monitoring/multiple reaction monitoring (SRM/MRM) quantification of peptides using a low-resolution (Rs ~1,000) tandem quadrupole mass spectrometer. One of the limitations of this approach is the interference phenomenon observed when the peptide of interest has the "same" precursor and fragment mass (in terms of m/z values) as other co-eluting peptides present in the sample (within a 1-Da window)...
April 17, 2018: Journal of Visualized Experiments: JoVE
Samar M Said, Fernando G Cosio, Anthony M Valeri, Nelson Leung, Sanjeev Sethi, Hassan Salameh, Lynn D Cornell, Mary E Fidler, Mariam P Alexander, Fernando C Fervenza, Maria Eleni Drosou, Da Zhang, Vivette D D'Agati, Samih H Nasr
The characteristics of allograft proliferative glomerulonephritis with monoclonal immunoglobulin G deposits (PGNMID) are not well defined. To better characterize this disease we retrospectively identified 26 patients with allograft PGNMID, including 16 followed with early protocol biopsies. PGNMID was found to be a recurrent disease in most (89%) patients. A diagnostic biopsy was done for proteinuria and/or increased creatinine in most patients. Median time from transplant to diagnostic biopsy was 5.5 months, with detection within three to four months post-transplant in 86% of patients...
April 28, 2018: Kidney International
Diogo M Magnani, Thomas F Rogers, Nicholas J Maness, Nathan D Grubaugh, Nathan Beutler, Varian K Bailey, Lucas Gonzalez-Nieto, Martin J Gutman, Núria Pedreño-Lopez, Jaclyn M Kwal, Michael J Ricciardi, Tereance A Myers, Justin G Julander, Rudolf P Bohm, Margaret H Gilbert, Faith Schiro, Pyone P Aye, Robert V Blair, Mauricio A Martins, Kathrine P Falkenstein, Amitinder Kaur, Christine L Curry, Esper G Kallas, Ronald C Desrosiers, Pascal J Goldschmidt-Clermont, Stephen S Whitehead, Kristian G Andersen, Myrna C Bonaldo, Andrew A Lackner, Antonito T Panganiban, Dennis R Burton, David I Watkins
Zika virus (ZIKV) infection of pregnant women is associated with pathologic complications of fetal development. Here, we infect pregnant rhesus macaques (Macaca mulatta) with a minimally passaged ZIKV isolate from Rio de Janeiro, where a high rate of fetal development complications was observed. The infection of pregnant macaques with this virus results in maternal viremia, virus crossing into the amniotic fluid (AF), and in utero fetal deaths. We also treated three additional ZIKV-infected pregnant macaques with a cocktail of ZIKV-neutralizing human monoclonal antibodies (nmAbs) at peak viremia...
April 24, 2018: Nature Communications
Anthony Ehkirch, Oscar Hernandez-Alba, Olivier Colas, Alain Beck, Davy Guillarme, Sarah Cianférani
Mass spectrometry performed in non-denaturing conditions (native MS), and its hyphenation to ion mobility spectrometry (IM-MS), have gained interest for the qualitative and quantitative characterization of intact monoclonal antibody-related (mAb) products. However, one main drawback is the manual sample preparation, which hampers its routine use in high throughput automated environments. Size exclusion chromatography (SEC) appears as an interesting technique to perform online buffer exchange in an automated way...
June 1, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Camila Peña, María José Marti, Pablo Villegas, María Soledad Undurraga
No abstract text is available yet for this article.
November 2017: Revista Médica de Chile
Qing Li, Jason B White, Norman C Peterson, Keith W Rickert, Christopher O Lloyd, Kevin L Allen, Kim Rosenthal, Xizhe Gao, Herren Wu, William F Dall'Acqua, M Jack Borrok, Ping Tsui
The accumulation, dissemination and clearance of monoclonal antibody-based therapeutics or imaging reagents targeting tumor associated antigens is governed by several factors including affinity, size, charge, and valency. Tumor targeting antibody fragments have distinct advantages over intact monoclonal antibodies such as enhanced penetration within the tumor and rapid accumulation but are subject to rapid clearance. Polyethylene glycol (PEG)-modified antibody fragments can provide a way to balance tumor penetration and accumulation with improved serum persistence...
June 10, 2018: Journal of Controlled Release: Official Journal of the Controlled Release Society
Cory King, Rekha Patel, Gomathinayagam Ponniah, Christine Nowak, Alyssa Neill, Zhenyu Gu, Hongcheng Liu
In-depth characterization of the commonly observed variants is critical to the successful development of recombinant monoclonal antibody therapeutics. Multiple peaks of a recombinant monoclonal antibody were observed when analyzed by hydrophobic interaction chromatography and imaged capillary isoelectric focusing. The potential modification causing the heterogeneity was localized to F(ab')2 region by analyzing the antibody after IdeS digestion using hydrophobic interaction chromatography. LC-MS analysis identified asparagine deamidation as the root cause of the observed multiple variants...
May 15, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Balázs Bobály, Matthew Lauber, Alain Beck, Davy Guillarme, Szabolcs Fekete
A wide-pore silica-based superficially porous material with a high coverage phenyl bonding was evaluated for the analysis of monoclonal antibodies and antibody-drug conjugates. This new material is based on 2.7 μm particles having a shell thickness of 0.40 μm and average pore size of approximately 450 Å. Various important features of this reversed phase column technology were explored, including kinetic performance for large biomolecules (i.e. speed of analysis, efficiency and peak capacity), recovery of proteins, selectivity for resolving modifications, and the possibility to reduce the amount of trifluoroacetic acid in the mobile phase...
May 11, 2018: Journal of Chromatography. A
Chen Zheng, Chao Zhuang, Jinyan Qin, Yantian Chen, Qiang Fu, Hui Qian, Tong Wu, Yanchao Wang, Xiang Wu, Nianmin Qi
Charge heterogeneity has been broadly studied as a critical quality attribute during monoclonal antibody (mAb) production that may subsequently affect product stability and biopotency. However, the charge variation distribution is poorly controlled, so methods of more effective control need to be explored. In this study, the combined effects of temperature shift (37-34, 37-32, or 37-30 °C) and hydrolysate addition (0.100 g/L) to culture feed on the charge heterogeneity of anti-IgE mAb were investigated. The results showed that the distribution of charge variation was significantly regulated by the combination of hydrolysate addition with a highly sub-physiological temperature (34 °C)...
March 27, 2018: Cytotechnology
Kevin Hollevoet, Elien De Smidt, Nick Geukens, Paul Declerck
Antibody gene transfer presents an appealing alternative to conventional antibody protein therapy. This pre-clinical study evaluates the impact of various parameters on the pharmacokinetics and efficacy of in vivo expressed DNA-based anti-HER2 monoclonal antibodies (mAbs), newly engineered and delivered via intramuscular electrotransfer in mice. Plasma concentrations of trastuzumab and 4D5, its murine IgG1 equivalent, peaked on average between 1-15 µg/ml, depending on the administration and configuration of the encoding plasmid DNA (pDNA)...
March 2, 2018: Oncotarget
Deepti Ahluwalia, Madesh Belakavadi, Tapan K Das, Amit Katiyar
Product identity is one of the release testing requirements that needs to be established to ensure that there is no misidentification of drugs. Here, we demonstrated the challenges that can come across while establishing a product identity method for monoclonal antibody (mAb) and mAb-related products using icIEF method. A unique three-point identity criteria tool (visual comparison, pI of individual peaks and ΔpIs) was applied to distinguish mAb1 from the other in-house mAbs. A reduction approach followed by icIEF showed higher potential for establishing identity for mAb1 product as compared to native and enzymatic digestion approach...
April 15, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Thomas Theis, Anmol Singh Johal, Maciej Kabat, Sayantani Basak, Melitta Schachner
Glycosylation fine-tunes signal transduction of adhesion molecules during neural development and supports synaptic plasticity and repair after injury in the adult nervous system. One abundantly expressed neural glycan is LewisX (LeX). Although it is known that its expression starts at the formation of the neural tube during the second embryonic week in the mouse and peaks during the first postnatal week, its functional relevance is only rudimentarily understood. To gain better insights into the functions of this glycan, we identified small organic compounds that mimic structurally and functionally this glycan glycosidically linked to several neural adhesion molecules...
March 8, 2018: Molecular Neurobiology
Latifa Mohammadi, Noria Harir, Mohamed Brahimi, Soraya Moulessehoul, Mohamed Amine Bekadja
BACKGROUND: Multiple Myeloma (MM) represent about 1 to 2% of cancers and 15% of all hematological malignancies. It is characterized by malignant proliferation of plasmocytes in bone marrow and an excess of secreted monoclonal immunoglobulins (Ig) Objective: Describe the epidemiological, clinical, biological and prognosis of patients with MM treated with autologous peripheral hematopoietic stem cell transplantation (APHSCT) in the Algerian West. METHODS: It is a retrospective descriptive study covering all MM patients treated with APHSCT over a period of 7 years (2008-2015) at service of Haematology and Cell Therapy of the EHU "1er November 1954 of Oran, Algeria...
June 2017: La Tunisie Médicale
Nissreen Mohammad, Vishal Avinashi, Edmond Chan, Bruce A Vallance, Elodie Portales-Casamar, Jonathan W Bush
OBJECTIVE: Eosinophilic esophagitis (EoE) is considered a TH2-mediated food allergy disease that leads to submucosal esophageal fibrosis and strictures. Recent studies focused on adults with EoE identified a strong association with elevated esophageal IgG4 immunostaining. Our study aimed to determine the association of IgG4 with EoE in pediatric patients. METHODS: Using our local EoE research registry, we identified 41 adequate biopsies from EoE patients. We used 10 age- and sex-matched patients with no diagnostic abnormalities at endoscopy or on biopsy...
March 5, 2018: Journal of Pediatric Gastroenterology and Nutrition
Staci L Haney, Yashpal S Chhonker, Michelle L Varney, Geoffrey Talmon, Daryl J Murry, Sarah A Holstein
Geranylgeranyl diphosphate synthase (GGDPS) is the enzyme in the isoprenoid biosynthesis pathway that catalyzes the synthesis of the 20-carbon isoprenoid GGPP, which serves as the isoprenoid donor for protein geranylgeranylation reactions. Rab proteins mediate vesicle trafficking within the cell and their activity is dependent on geranylgeranylation. Our prior work has demonstrated that agents that disrupt Rab geranylgeranylation disrupt monoclonal protein trafficking in myeloma cells, resulting in induction of the unfolded protein response pathway and apoptosis...
March 2, 2018: Investigational New Drugs
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