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mAB aggregates

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https://www.readbyqxmd.com/read/28089934/evaluation-of-aggregate-and-silicone-oil-counts-in-pre-filled-siliconized-syringes-an-orthogonal-study-characterising-the-entire-subvisible-size-range
#1
Maryam Shah, Zahra Rattray, Katie Day, Shahid Uddin, Robin Curtis, Christopher F van der Walle, Alain Pluen
Characterisation of particulates in therapeutic monoclonal antibody (mAb) formulations is routinely extended to the sub-visible size-range (0.1-10μm). Additionally, with the increased use of pre-filled syringes (PFS), particle differentiation is required between proteinaceous and non-proteinaceous particles such as silicone-oil droplets. Here, three orthogonal techniques: Raster Image Correlation Spectroscopy (RICS), Resonance Mass Measurements (RMM) and Micro-Flow Imaging (MFI), were evaluated with respect to their sub-visible particle measurement and characterisation capabilities...
January 9, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28054640/honokiol-as-a-specific-collagen-receptor-glycoprotein-vi-antagonist-on-human-platelets-functional-ex-vivo-and-in-vivo-studies
#2
Tzu-Yin Lee, Chao-Chien Chang, Wan-Jung Lu, Ting-Lin Yen, Kuan-Hung Lin, Pitchairaj Geraldine, Jiun-Yi Li, Joen-Rong Sheu
Honokiol, derived from Magnolia officinalis, has various pharmacological properties. Platelet activation plays a critical role in cardiovascular diseases. Honokiol has been reported to inhibit collagen-stimulated rabbit platelet aggregation. However, detailed further studies on the characteristics and functional activity of honokiol in platelet activation are relatively lacking. In the present study, honokiol specifically inhibited platelet aggregation and Ca(+2) ion mobilization stimulated with collagen or convulxin, an agonist of glycoprotein (GP) VI, but not with aggretin, an agonist of integrin α2β1...
January 5, 2017: Scientific Reports
https://www.readbyqxmd.com/read/27982442/assessment-of-disulfide-and-hinge-modifications-of-monoclonal-antibodies
#3
REVIEW
Bernd Moritz, Jan Olaf Stracke
During the last years there was a substantial increase in the use of antibodies and related proteins as therapeutics. The emphasis of the pharmaceutical industry is on IgG1, IgG2 and IgG4 antibodies which are therefore in the focus of this article. In order to ensure appropriate quality control of such biopharmaceuticals, deep understanding of their chemical degradation pathways and the resulting impact on potency, pharmacokinetics and safety is required. Criticality of modifications may be specific for individual antibodies and has to be assessed for each molecule...
December 16, 2016: Electrophoresis
https://www.readbyqxmd.com/read/27964939/shipping-induced-aggregation-in-therapeutic-antibodies-utilization-of-a-scale-down-model-to-assess-degradation-in-mabs
#4
Marianna L Fleischman, Jonathan Chung, Eden P Paul, Rachael A Lewus
It is vital to understand the impact of transportation on monoclonal antibody (mAb) product quality during drug product development. Fully representative real-time shipment studies are resource intensive, so in this work we studied laboratory agitation methods to mimic the effect of real-time shipment on aggregation, specifically sub-visible particle formation. The agitation methods studied include a rotator, orbital shaker, vortexer, and shipping simulator vibration table. The simulator is able to predict the particle formation behavior during real-time shipment for a number of mAbs in vial and pre-filled syringe (PFS) configurations, with a correlation of about 90%, while the other methods of agitation were inconsistent...
December 10, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27943050/in-vitro-evaluation-of-beneficial-properties-of-bacteriocinogenic-lactobacillus-plantarum-st8sh
#5
Svetoslav Dimitrov Todorov, Wilhelm Holzapfel, Luis Augusto Nero
Lactobacillus plantarum ST8Sh, isolated from Bulgarian salami "shpek" and previously characterized as bacteriocin producer, was evaluated for its beneficial properties. Based on the PCR analysis, Lb. plantarum ST8Sh was shown to host a gene related to the production of adhesion proteins such as Mab, Mub, EF, and PrgB. Genetic and physiological tests suggest Lb. plantarum ST8Sh to represent a potential probiotic candidate, including survival in the presence of low levels of pH and high levels of ox bile, production of β-galactosidase, bile salt deconjugation, high level of hydrophobicity, functional auto- and co-aggregation properties, and adhesion to cell lines...
December 10, 2016: Probiotics and Antimicrobial Proteins
https://www.readbyqxmd.com/read/27939321/transfer-of-a-three-step-mab-chromatography-process-from-batch-to-continuous-optimizing-productivity-to-minimize-consumable-requirements
#6
Xhorxhi Gjoka, Rene Gantier, Mark Schofield
The goal of this study was to adapt a batch mAb purification chromatography platform for continuous operation. The experiments and rationale used to convert from batch to continuous operation are described. Experimental data was used to design chromatography methods for continuous operation that would exceed the threshold for critical quality attributes and minimize the consumables required as compared to batch mode of operation. Four unit operations comprising of Protein A capture, viral inactivation, flow-through anion exchange (AEX), and mixed-mode cation exchange chromatography (MMCEX) were integrated across two Cadence BioSMB PD multi-column chromatography systems in order to process a 25L volume of harvested cell culture fluid (HCCF) in less than 12h...
January 20, 2017: Journal of Biotechnology
https://www.readbyqxmd.com/read/27914608/evaluation-of-size-exclusion-chromatography-columns-packed-with-sub-3%C3%AE-m-particles-for-the-analysis-of-biopharmaceutical-proteins
#7
Alexandre Goyon, Alain Beck, Olivier Colas, Koen Sandra, Davy Guillarme, Szabolcs Fekete
The aim of this study was to evaluate the practical possibilities and limitations of several recently introduced size exclusion chromatographic (SEC) columns of 150×4.6mm, sub-3μm (Agilent AdvanceBioSEC 2.7μm, Tosoh TSKgel UP-SW3000 2.0μm, Phenomenex Yarra SEC X-150 1.8μm and Waters Acquity BEH200 1.7μm) for the separation of biopharmaceutical proteins. For this purpose, some model proteins were tested, as well as several commercial therapeutic monoclonal antibodies (mAbs) and antibody-drug-conjugates (ADCs)...
November 27, 2016: Journal of Chromatography. A
https://www.readbyqxmd.com/read/27855600/optimization-on-fc-for-improvement-of-stability-and-aggregation-resistance
#8
Xiaobo Chen, Fang Zeng, Tao Huang, Liang Cheng, Huan Liu, Rui Gong
Fc-based therapeutics including therapeutic full-size monoclonal antibodies (mAbs) and Fc-fusion proteins represent fastest-growing market in biopharmaceutical industrial. However, one major challenge during development of Fc-based therapeutics is how to maintain their efficacy in clinic use. Many factors may lead to failure in final marketing. For example, the stability and aggregation resistance might not be high enough for bearing the disadvantages during fermentation, purification, formulation, storage, shipment and other steps in manufacture and sale...
November 17, 2016: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/27789805/processing-impact-on-monoclonal-antibody-drug-products-protein-subvisible-particulate-formation-induced-by-grinding-stress
#9
Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S Day, Oliver Boris Stauch, Yuh-Fun Maa
Subvisible particle formation in monoclonal antibody (mAb) drug product resulting from mixing and filling operations represents a significant processing risk that can lead to filter fouling and thereby lead to process delays or failures. Several previous studies from our lab and others demonstrated the formation of subvisible particulates in mAb formulations resulting from mixing operations using some bottom-mounted mixers or stirrer bars. It was hypothesized that the stress (e.g. shear/cavitation) derived from tight clearance and/or close contact between the impeller and shaft was responsible for SvP generation...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27788030/pmab-38-recognizes-canine-podoplanin-of-squamous-cell-carcinomas
#10
Mika K Kaneko, Ryusuke Honma, Satoshi Ogasawara, Yuki Fujii, Takuro Nakamura, Noriko Saidoh, Michiaki Takagi, Yumiko Kagawa, Satoru Konnai, Yukinari Kato
Podoplanin, a type I transmembrane protein, is expressed in lymphatic endothelial cells. Although we previously developed an anticanine podoplanin monoclonal antibody (mAb), PMab-38, immunohistochemistry (IHC) showed that it did not react with canine lymphatic endothelial cells. Here, we determined whether PMab-38 recognizes canine podoplanin of squamous cell carcinomas (SCCs) and clarified its epitope. In IHC, PMab-38 reacted with 83% of SCCs (15/18 cases). Flow cytometry showed that the epitope of PMab-38 was different from that of the platelet aggregation-stimulating domain of the N-terminus, which was detected by almost all antipodoplanin mAbs such as D2-40 or NZ-1...
October 2016: Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
https://www.readbyqxmd.com/read/27699633/antibody-based-drugs-and-approaches-against-amyloid-%C3%AE-species-for-alzheimer-s-disease-immunotherapy
#11
REVIEW
Jing Liu, Bin Yang, Jun Ke, Wenjia Li, Wen-Chen Suen
Alzheimer's disease (AD), one of the most devastating diseases for the older population, has become a major healthcare burden in the increasingly aging society worldwide. Currently, there are still only symptomatic treatments available on the market, just to slow down disease progression. In the past decades, extensive research focusing on the development of immunotherapy using monoclonal antibodies (mAbs) as potential "disease-modifying drugs" has shown promise in inhibiting or clearing the formation of toxic amyloid-β (Aβ) species, the suspected causative agents of AD...
October 2016: Drugs & Aging
https://www.readbyqxmd.com/read/27697310/comprehensive-study-on-the-effects-of-sodium-and-potassium-additives-in-size-exclusion-chromatographic-separations-of-protein-biopharmaceuticals
#12
Alexandre Goyon, Alain Beck, Jean-Luc Veuthey, Davy Guillarme, Szabolcs Fekete
To separate proteins solely based on their difference in hydrodynamic volume in size exclusion chromatography (SEC), the ionic strength of the mobile phase has to be increased in order to avoid secondary ionic interactions between proteins and the stationary phase. However, adding salts to the mobile phase can have a serious effect on protein aggregation and can lead to artifacts. In the present study, several monoclonal antibodies (mAbs) and the antibody-drug conjugate (ADC), trastuzumab emtansine were selected to study the effect of mobile phase salt additive on aggregation measurements...
September 26, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/27660109/choosing-the-right-protein-a-affinity-chromatography-media-can-remove-aggregates-efficiently
#13
Tomokazu Yada, Koichi Nonaka, Masayuki Yabuta, Noriko Yoshimoto, Shuichi Yamamoto
Protein A chromatography (PAC) is commonly used as an efficient capture step in monoclonal antibody (mAb) separation processes. Usually dynamic binding capacity is used for choosing the right PAC. However, if aggregates can be efficiently removed during elution, it can make the following polishing steps easier. In this study a method for choosing the right PAC media in terms of mAb aggregate removal is proposed. Linear pH gradient elution experiments of two different mAbs on various PAC columns are carried out, where the elution behavior of aggregates as well as the monomer is measured...
September 23, 2016: Biotechnology Journal
https://www.readbyqxmd.com/read/27643824/a-method-to-measure-protein-unfolding-at-an-air-liquid-interface
#14
Danielle L Leiske, Ian C Shieh, Martha Lovato Tse
Proteins are surface-active molecules that have a propensity to adsorb to hydrophobic interfaces, such as the air-liquid interface. Surface flow can increase aggregation of adsorbed proteins, which may be an undesirable consequence depending on the application. As changes in protein conformation upon adsorption are thought to induce aggregation, the ability to measure the folded state of proteins at interfaces is of particular interest. However, few techniques currently exist to measure protein conformation at interfaces...
October 4, 2016: Langmuir: the ACS Journal of Surfaces and Colloids
https://www.readbyqxmd.com/read/27589351/characterizing-monoclonal-antibody-formulations-in-arginine-glutamate-solutions-using-1-h-nmr-spectroscopy
#15
Priscilla Kheddo, Matthew J Cliff, Shahid Uddin, Christopher F van der Walle, Alexander P Golovanov
Assessing how excipients affect the self-association of monoclonal antibodies (mAbs) requires informative and direct in situ measurements for highly concentrated solutions, without sample dilution or perturbation. This study explores the application of solution nuclear magnetic resonance (NMR) spectroscopy for characterization of typical mAb behavior in formulations containing arginine glutamate. The data show that the analysis of signal intensities in 1D (1)H NMR spectra, when compensated for changes in buffer viscosity, is invaluable for identifying conditions where protein-protein interactions are minimized...
August 11, 2016: MAbs
https://www.readbyqxmd.com/read/27568167/a-simple-and-efficient-purification-platform-for-monoclonal-antibody-production-based-on-chromatin-directed-cell-culture-clarification-integrated-with-precipitation-and-void-exclusion-anion-exchange-chromatography
#16
Quan Chen, Sarah Maria Abdul Latiff, Phyllicia Toh, Xinying Peng, Aina Hoi, Mo Xian, Haibo Zhang, Rui Nian, Wei Zhang, Pete Gagnon
Protein A affinity chromatography, featured by its robustness and high-specificity, is still dominant as a first capture step for the purification of immunoglobulin G monoclonal antibodies (IgG mAbs). However, the material and operational costs of protein A are universally recognized as high, and its productivity is also limited as column mode. In order to overcome these limitations, industry is increasingly considering the use of non-protein A-based processes for IgG purification. In this study, sodium citrate precipitation (SCP) was developed as the primary purification step, and chromatin-directed cell culture clarification was demonstrated to significantly elevate the purification capability...
October 20, 2016: Journal of Biotechnology
https://www.readbyqxmd.com/read/27564251/lpmab-19-recognizes-sialylated-o-glycan-on-thr76-of-human-podoplanin
#17
Satoshi Ogasawara, Mika K Kaneko, Yukinari Kato
Human podoplanin (hPDPN) is expressed in lymphatic vessels, pulmonary type-I alveolar cells, and renal glomerulus. The hPDPN/C-type lectin-like receptor-2 (CLEC-2) interaction is involved in platelet aggregation and cancer metastasis. High expression of hPDPN in cancer cells or cancer-associated fibroblasts (CAFs) leads to a poor prognosis for cancer patients. In our previous research, we reported on several anti-hPDPN monoclonal antibodies (mAbs), including LpMab-2, LpMab-3, LpMab-7, LpMab-9, LpMab-12, LpMab-13, and LpMab-17 of mouse IgG1 subclass, which were produced using CasMab technology...
August 26, 2016: Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
https://www.readbyqxmd.com/read/27494246/use-of-in-vitro-assays-to-assess-immunogenicity-risk-of-antibody-based-biotherapeutics
#18
Marisa K Joubert, Meghana Deshpande, Jane Yang, Helen Reynolds, Christine Bryson, Mark Fogg, Matthew P Baker, Jonathan Herskovitz, Theresa J Goletz, Lei Zhou, Michael Moxness, Gregory C Flynn, Linda O Narhi, Vibha Jawa
An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral blood mononuclear cells from up to 50 healthy naïve human donors were monitored up to 8 days for T-cell proliferation, the number of IL-2 or IFN-γ secreting cells, and the concentration of a panel of secreted cytokines. The response in the assay to 10 monoclonal antibodies was found to be in agreement with the clinical immunogenicity, suggesting that the assay might be applied to immunogenicity risk assessment of antibody biotherapeutic attributes...
2016: PloS One
https://www.readbyqxmd.com/read/27484800/ligand-induced-epitope-masking-dissociation-of-integrin-%C3%AE-5%C3%AE-1-fibronectin-complexes-only-by-monoclonal-antibodies-with-an-allosteric-mode-of-action
#19
A Paul Mould, Janet A Askari, Adam Byron, Yoshikazu Takada, Thomas A Jowitt, Martin J Humphries
We previously demonstrated that Arg-Gly-Asp (RGD)-containing ligand-mimetic inhibitors of integrins are unable to dissociate pre-formed integrin-fibronectin complexes (IFCs). These observations suggested that amino acid residues involved in integrin-fibronectin binding become obscured in the ligand-occupied state. Because the epitopes of some function-blocking anti-integrin monoclonal antibodies (mAbs) lie near the ligand-binding pocket, it follows that the epitopes of these mAbs may become shielded in the ligand-occupied state...
September 30, 2016: Journal of Biological Chemistry
https://www.readbyqxmd.com/read/27452807/effect-of-charge-localization-on-the-in-vivo-optical-imaging-properties-of-near-infrared-cyanine-dye-monoclonal-antibody-conjugates
#20
Kazuhide Sato, Alexander P Gorka, Tadanobu Nagaya, Megan S Michie, Yuko Nakamura, Roger R Nani, Vince L Coble, Olga V Vasalatiy, Rolf E Swenson, Peter L Choyke, Martin J Schnermann, Hisataka Kobayashi
Near-infrared (NIR) fluorophores show superior in vivo imaging properties than visible-light fluorophores because of the increased light penetration in tissue and lower autofluorescence of these wavelengths. We have recently reported that new NIR cyanine dyes containing a novel C4'-O-alkyl linker exhibit greater chemical stability and excellent optical properties relative to existing C4'-O-aryl variants. In this study, we synthesized two NIR cyanine dyes with the same core structure and charge but different indolenine substituents: FNIR-Z-759 bearing a combination of two sulfonates and two quaternary ammonium cations, and FNIR-G-765 bearing a combination of two sulfonates and two guanidines, resulting in zwitterionic charge with distinct cationic moieties...
October 20, 2016: Molecular BioSystems
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