Specific and high-resolution identification of monoclonal antibody fragments detected by capillary electrophoresis-sodium dodecyl sulfate using reversed-phase HPLC with top-down mass spectrometry analysis.

abstract：:Bispecific antibody therapeutics can expand the functionality of a conventional monoclonal antibody drug because they can bind multiple antigens. However, their great potential is counterbalanced by the challenges faced in their production. The classic asymmetric bispecific containing an Fc requires the expression of ...

journal_title：mAbs

authors： Cooke HA,Arndt J,Quan C,Shapiro RI,Wen D,Foley S,Vecchi MM,Preyer M

更新日期：2018-11-01 00:00:00

abstract：:Efficient production of large quantities of therapeutic antibodies is becoming a major goal of the pharmaceutical industry. We developed a proprietary expression system using a polyprotein precursor-based approach to antibody expression in mammalian cells. In this approach, the coding regions for heavy and light chain...

journal_title：mAbs

authors： Gion WR,Davis-Taber RA,Regier DA,Fung E,Medina L,Santora LC,Bose S,Ivanov AV,Perilli-Palmer BA,Chumsae CM,Matuck JG,Kunes YZ,Carson GR

更新日期：2013-07-01 00:00:00

abstract：:The importance of antibodies in activating immune responses against tumors is now better appreciated with the emergence of checkpoint blockade antibodies and with engineered antibody Fc domains featuring enhanced capacity to focus potent effector cells against cancer cells. Antibodies designed with Fc regions of the I...

journal_title：mAbs

authors： Josephs DH,Spicer JF,Karagiannis P,Gould HJ,Karagiannis SN

更新日期：2014-01-01 00:00:00

abstract：:Fusion to an IgG Fc region is an established strategy to extend the half-life of therapeutic proteins. Most Fc fusion proteins, however, do not achieve the long half-life of IgGs. Based on findings that scFv-Fc fusion proteins exhibit a shorter half-life than the corresponding IgG molecules, we performed a comparative...

journal_title：mAbs

authors： Unverdorben F,Richter F,Hutt M,Seifert O,Malinge P,Fischer N,Kontermann RE

更新日期：2016-01-01 00:00:00

abstract：:Much data support a role for central nervous system antigen-specific antibodies in the pathogenesis of multiple sclerosis (MS). The effects of inducing a decrease in (auto)antibody levels on MS or experimental autoimmune encephalomyelitis (EAE) through specific blockade of FcRn, however, remain unexplored. We recently...

journal_title：mAbs

authors： Challa DK,Bussmeyer U,Khan T,Montoyo HP,Bansal P,Ober RJ,Ward ES

更新日期：2013-09-01 00:00:00

abstract：:The American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference Short Course "Translational Challenges in Developing Antibody-Drug Conjugates (ADCs)," held May 24, 2012 in San Diego, CA, was organized by members of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism section of AAP...

journal_title：mAbs

authors： Thudium K,Bilic S,Leipold D,Mallet W,Kaur S,Meibohm B,Erickson H,Tibbitts J,Zhao H,Gupta M

更新日期：2013-01-01 00:00:00

abstract：:The development of antibody therapeutics relies on animal models that accurately recapitulate disease biology. Syngeneic mouse models are increasingly used with new molecules to capture the biology of complex cancers and disease states, and to provide insight into the role of the immune system. The establishment of sy...

journal_title：mAbs

authors： Wang F,Tsai JC,Davis JH,Chau B,Dong J,West SM,Hogan JM,Wheeler ML,Bee C,Morishige W,Cayton T,David-Brown D,Zhang C,Kozhich A,Sproul T,Dollinger G,Rajpal A,Strop P

更新日期：2020-01-01 00:00:00

abstract：:The development of alternative therapeutic strategies to tumor necrosis factor (TNF)-blocking antibodies for the treatment of inflammatory diseases has generated increasing interest. In particular, selective inhibition of TNF receptor 1 (TNFR1) promises a more precise intervention, tackling only the pro-inflammatory r...

journal_title：mAbs

authors： Richter F,Seifert O,Herrmann A,Pfizenmaier K,Kontermann RE

更新日期：2019-05-01 00:00:00

abstract：:The neonatal Fc receptor (FcRn) plays an important and well-known role in antibody recycling in endothelial and hematopoietic cells and thus it influences the systemic pharmacokinetics (PK) of immunoglobulin G (IgG). However, considerably less is known about FcRn's role in the metabolism of IgG within individual tissu...

journal_title：mAbs

authors： Yip V,Palma E,Tesar DB,Mundo EE,Bumbaca D,Torres EK,Reyes NA,Shen BQ,Fielder PJ,Prabhu S,Khawli LA,Boswell CA

更新日期：2014-05-01 00:00:00

abstract：:Antibodies that target a clinically relevant group of receptors within the tumor necrosis factor receptor superfamily (TNFRSF), including CD40 and CD95 (Fas/Apo-1), also require binding to Fc gamma receptors (FcγRs) to elicit a strong agonistic activity. This FcγR dependency largely relies on the mere cellular anchori...

journal_title：mAbs

authors： Nelke J,Medler J,Weisenberger D,Beilhack A,Wajant H

更新日期：2020-01-01 00:00:00

abstract：:Post-translational modifications can have a signification effect on antibody stability. A comprehensive approach is often required to best understand the underlying reasons the modification affects the antibody's potency or aggregation state. Monoclonal antibody 001 displayed significant variation in terms of potency,...

journal_title：mAbs

authors： McSherry T,McSherry J,Ozaeta P,Longenecker K,Ramsay C,Fishpaugh J,Allen S

更新日期：2016-05-01 00:00:00

abstract：:Monoclonal antibodies play an increasingly important role for the development of new drugs across multiple therapy areas. The term 'developability' encompasses the feasibility of molecules to successfully progress from discovery to development via evaluation of their physicochemical properties. These properties includ...

journal_title：mAbs

authors： Bailly M,Mieczkowski C,Juan V,Metwally E,Tomazela D,Baker J,Uchida M,Kofman E,Raoufi F,Motlagh S,Yu Y,Park J,Raghava S,Welsh J,Rauscher M,Raghunathan G,Hsieh M,Chen YL,Nguyen HT,Nguyen N,Cipriano D,Fayadat-Dilma

更新日期：2020-01-01 00:00:00

abstract：:Plasmacytoid dendritic cells (pDCs) play a central role for both innate and adaptive antiviral responses, as they direct immune responses through their unique ability to produce substantial concentrations of type I interferon (IFNs) upon viral encounter while also activating multiple immune cells, including macrophage...

journal_title：mAbs

authors： Fournier N,Jacque E,Fontayne A,Derache D,Dupont G,Verhaeghe L,Baptista L,Dehenne A,Dezetter AS,Terrier A,Longue A,Pochet-Beghin V,Beghin C,Chtourou S,de Romeuf C

更新日期：2018-05-01 00:00:00

abstract：:Non-enzymatic glycation is a challenging post-translational modification to characterize due to the structural heterogeneity it generates in proteins. Glycation has become increasingly recognized as an important product quality attribute to monitor, particularly for the biotechnology sector, which produces recombinant...

journal_title：mAbs

authors： Saleem RA,Affholter BR,Deng S,Campbell PC,Matthies K,Eakin CM,Wallace A

更新日期：2015-01-01 00:00:00

abstract：:Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to b...

journal_title：mAbs

authors： Socinski MA,Curigliano G,Jacobs I,Gumbiner B,MacDonald J,Thomas D

更新日期：2015-01-01 00:00:00

abstract：:Antibody-drug conjugates (ADCs) that exploit the active metabolite SN-38, which is derived from the popular anticancer drug, irinotecan (a camptothecin that inhibits the nuclear topoisomerase I enzyme, inducing double-stranded DNA breaks during the mitotic S-phase of affected cells), represent a substantial advance in...

journal_title：mAbs

authors： Goldenberg DM,Sharkey RM

更新日期：2019-08-01 00:00:00

abstract：:The neonatal Fc receptor (FcRn) promotes antibody recycling through rescue from normal lysosomal degradation. The binding interaction is pH-dependent with high affinity at low pH, but not under physiological pH conditions. Here, we combined rational design and saturation mutagenesis to generate novel antibody variants...

journal_title：mAbs

authors： Mackness BC,Jaworski JA,Boudanova E,Park A,Valente D,Mauriac C,Pasquier O,Schmidt T,Kabiri M,Kandira A,Radošević K,Qiu H

更新日期：2019-10-01 00:00:00

abstract：:In the present study, we conducted a Phase 1 study of a recombinant anti-EGFR monoclonal antibody (CMAB009) that has the same amino acid sequence as cetuximab. The purpose of this study was to evaluate the safety, pharmacokinetics, and potential benefit of CMAB009 in Chinese patients with advanced chemotherapy-resista...

journal_title：mAbs

authors： Wang C,He X,Zhou B,Li J,Li B,Qian W,Hou S,Wang H,Shi Y,Guo Y

更新日期：2011-01-01 00:00:00

abstract：:The Fc glycosylation of therapeutic antibodies is crucial for their effector functions and their behavior in pharmacokinetics and pharmacodynamics. To monitor the Fc glycosylation in bioprocess development and characterization,high-throughput techniques for glycosylation analysis are needed. Here, we describe the deve...

journal_title：mAbs

authors： Reusch D,Haberger M,Kailich T,Heidenreich AK,Kampe M,Bulau P,Wuhrer M

更新日期：2014-01-01 00:00:00

abstract：:The cervical mucosa of women who are highly exposed to HIV-1, yet remain persistently seronegative (HEPS), presents a unique opportunity to study the dynamics of an immune compartment potentially capable of preventing HIV-1 infection. Herein, we provide a detailed characterization of the immunoglobulin repertoire of c...

journal_title：mAbs

authors： Gaudet RG,Breden F,Plummer F,Berry JD

更新日期：2011-03-01 00:00:00

abstract：:Ang1 is a soluble ligand to receptor Tie2, and increasing the circulating Ang1 level may improve vascular stabilization under certain disease conditions. Here, we found that the circulating Ang1 level was significantly increased in cynomolgus monkeys treated with non-neutralizing anti-Ang1 antibodies. Improving the an...

journal_title：mAbs

authors： Zheng C,Toth J,Bigwarfe T,MacDougall M,Jerath K,Bovat K,Smith J,Sun P,Hayes D,Fryer R,Singh S,Kroe-Barrett R

更新日期：2018-11-01 00:00:00

abstract：:Therapeutic monoclonal antibodies (mAbs) currently dominate the biologics marketplace. Development of a new therapeutic mAb candidate is a complex, multistep process and early stages of development typically begin in an academic research environment. Recently, a number of facilities and initiatives have been launched ...

journal_title：mAbs

authors： Munro TP,Mahler SM,Huang EP,Chin DY,Gray PP

更新日期：2011-09-01 00:00:00

abstract：:The plasticity of natural immunoglobulin repertoires can be exploited for the generation of phage display libraries. Secondary lymphoid organs, such as the spleen and the lymph nodes, constitute interesting sources of diversity because they are rich in B cells, part of which can be affinity matured. These organs, howe...

journal_title：mAbs

authors： Venet S,Kosco-Vilbois M,Fischer N

更新日期：2013-09-01 00:00:00

abstract：:Accurate measurement and functional characterization of antibody Fc domain N-linked glycans is critical to successful biosimilar development. Here, we describe the application of methods to accurately quantify and characterize the N-linked glycans of 2 IgG1 biosimilars with effector function activity, and show the pot...

journal_title：mAbs

authors： Brady LJ,Velayudhan J,Visone DB,Daugherty KC,Bartron JL,Coon M,Cornwall C,Hinckley PJ,Connell-Crowley L

更新日期：2015-01-01 00:00:00

abstract：:The critical role played by IgE in allergic asthma is well-documented and clinically precedented, but some patients in whom IgE neutralization may still offer clinical benefit are excluded from treatment with the existing anti-IgE therapy, omalizumab, due to high total IgE levels or body mass. In this study, we sought...

journal_title：mAbs

authors： Cohen ES,Dobson CL,Käck H,Wang B,Sims DA,Lloyd CO,England E,Rees DG,Guo H,Karagiannis SN,O'Brien S,Persdotter S,Ekdahl H,Butler R,Keyes F,Oakley S,Carlsson M,Briend E,Wilkinson T,Anderson IK,Monk PD,von Wachenfe

更新日期：2014-05-01 00:00:00

abstract：:Glycosylation is an important post-translational modification during protein production in eukaryotic cells, and it is essential for protein structure, stability, half-life, and biological functions. In this study, we produced various monoclonal antibody (mAb) glycoforms from Chinese hamster ovary (CHO) cells, includi...

journal_title：mAbs

authors： Zheng K,Yarmarkovich M,Bantog C,Bayer R,Patapoff TW

更新日期：2014-05-01 00:00:00

abstract：:The neonatal Fc receptor (FcRn) is a key membrane protein that plays an integral role in serum immunoglobulin (IgG) recycling, which extends the half-life of antibody. In addition, FcRn is known to traffic antigen-bound immunoglobulins (Ag-IgGs), and to interact with immune complexes to facilitate the antigen cross-pr...

journal_title：mAbs

authors： Sun Y,Estevez A,Schlothauer T,Wecksler AT

更新日期：2020-01-01 00:00:00

abstract：:Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of ...

journal_title：mAbs

authors： Vana AM,Freyman AW,Reich SD,Yin D,Li R,Anderson S,Jacobs IA,Zacharchuk CM,Ewesuedo R

更新日期：2016-07-01 00:00:00

abstract：:During cell line development for an IgG1 antibody candidate (mAb1), a C-terminal extension was identified in 2 product candidate clones expressed in CHO-K1 cell line. The extension was initially observed as the presence of anomalous new peaks in these clones after analysis by cation exchange chromatography (CEX-HPLC) ...

journal_title：mAbs

authors： Scott RA,Rogers R,Balland A,Brady LJ

更新日期：2014-01-01 00:00:00

abstract：:Antibody engineering must be accompanied by mapping strategies focused on identifying the epitope recognized by each antibody to define its unique functional identity. High throughput fine specificity determination remains technically challenging. We review recent experiences aimed at revisiting the oldest and most ex...

journal_title：mAbs

authors： Rojas G,Tundidor Y,Infante YC

更新日期：2014-01-01 00:00:00