Effects of the FcRn developmental pharmacology on the pharmacokinetics of therapeutic monoclonal IgG antibody in pediatric subjects using minimal physiologically-based pharmacokinetic modelling.

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 neonatal Fc receptor (FcRn) is important for the metabolic fate of IgG antibodies in vivo. Analysis of the interaction between FcRn and IgG in vitro might provide insight into the structural and functional integrity of therapeutic IgG that may affect pharmacokinetics (PK) in vivo. We developed a standardized pH gr...

journal_title：mAbs

authors： Schlothauer T,Rueger P,Stracke JO,Hertenberger H,Fingas F,Kling L,Emrich T,Drabner G,Seeber S,Auer J,Koch S,Papadimitriou A

更新日期：2013-07-01 00:00:00

abstract：:Genomic studies have been revolutionized by the use of next generation sequencing (NGS) that delivers huge amounts of sequence information in a short span of time. The number of applications for NGS is rapidly expanding and significantly transforming many areas of life sciences. The field of antibody research and disc...

journal_title：mAbs

authors： Fischer N

更新日期：2011-01-01 00:00:00

abstract：:Patents provide one of the few protections companies can avail themselves of to help protect their therapeutic monoclonal antibody products. Just as the therapeutic monoclonal antibody field is constantly evolving, so too is the legal environment surrounding these inventions. In a series of articles, the general state...

journal_title：mAbs

authors： McCabe KW

更新日期：2009-07-01 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：: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：:Surface and interfacial adsorption of antibody molecules could cause structural unfolding and desorbed molecules could trigger solution aggregation, resulting in the compromise of physical stability. Although antibody adsorption is important and its relevance to many mechanistic processes has been proposed, few techni...

journal_title：mAbs

authors： Smith C,Li Z,Holman R,Pan F,Campbell RA,Campana M,Li P,Webster JR,Bishop S,Narwal R,Uddin S,van der Walle CF,Lu JR

更新日期：2017-04-01 00:00:00

abstract：:During the past two decades we have seen a phenomenal evolution of bispecific antibodies for therapeutic applications. The 'zoo' of bispecific antibodies is populated by many different species, comprising around 100 different formats, including small molecules composed solely of the antigen-binding sites of two antibo...

journal_title：mAbs

authors： Brinkmann U,Kontermann RE

更新日期：2017-02-01 00:00:00

abstract：:Monoclonal antibody (mAb) therapeutics have tremendous potential to benefit patients with lung diseases, for which there remains substantial unmet medical need. To capture the current state of mAb research and development in the area of respiratory diseases, the Research Center of Respiratory Diseases (CEPR-INSERM U11...

journal_title：mAbs

authors： Desoubeaux G,Reichert JM,Sleeman M,Reckamp KL,Ryffel B,Adamczewski JP,Sweeney TD,Vanbever R,Diot P,Owen CA,Page C,Lerondel S,Le Pape A,Heuze-Vourc'h N

更新日期：2016-08-01 00:00:00

abstract：:Monoclonal antibodies are used with great success in many different therapeutic domains. In order to satisfy the growing demand and to lower the production cost of these molecules, many alternative systems have been explored. Among them, the baculovirus/insect cells system is a good candidate. This system is very safe...

journal_title：mAbs

authors： Cérutti M,Golay J

更新日期：2012-05-01 00:00:00

abstract：:Multivalent mono- or bispecific antibodies are of increasing interest for therapeutic applications, such as efficient receptor clustering and activation, or dual targeting approaches. Here, we present a novel platform for the generation of Ig-like molecules, designated diabody-Ig (Db-Ig). The antigen-binding site of D...

journal_title：mAbs

authors： Seifert O,Rau A,Beha N,Richter F,Kontermann RE

更新日期：2019-07-01 00:00:00

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：:Ch-mAb7F9, a human-mouse chimeric monoclonal antibody (mAb) designed to bind (+)-methamphetamine (METH) with high affinity and specificity, was produced as a treatment medication for METH abuse. In these studies, we present the preclinical characterization that provided predictive evidence that ch-mAb7F9 may be safe a...

journal_title：mAbs

authors： Stevens MW,Tawney RL,West CM,Kight AD,Henry RL,Owens SM,Gentry WB

更新日期：2014-03-01 00:00:00

abstract：:Multispecific antibody formats provide a promising platform for the development of novel therapeutic concepts that could facilitate the generation of safer, more effective pharmaceuticals. However, the production and use of such antibody-based multispecifics is often made complicated by: 1) the instability of the anti...

journal_title：mAbs

authors： Egan TJ,Diem D,Weldon R,Neumann T,Meyer S,Urech DM

更新日期：2017-01-01 00:00:00

abstract：:Blockade of immune checkpoint pathways by programmed cell death protein 1 (PD-1) antibodies has demonstrated broad clinical efficacy against a variety of malignancies. Sintilimab, a highly selective, fully human monoclonal antibody (mAb), blocks the interaction of PD-1 and its ligands and has demonstrated clinical ben...

journal_title：mAbs

authors： Wang J,Fei K,Jing H,Wu Z,Wu W,Zhou S,Ni H,Chen B,Xiong Y,Liu Y,Peng B,Yu D,Jiang H,Liu J

更新日期：2019-11-01 00:00:00

abstract：:Tremendous knowledge has been gained in the understanding of various modifications of IgG antibodies, driven mainly by the fact that antibodies are one of the most important groups of therapeutic molecules and because of the development of advanced analytical techniques. Recombinant monoclonal antibody (mAb) therapeut...

journal_title：mAbs

authors： Liu H,Ponniah G,Zhang HM,Nowak C,Neill A,Gonzalez-Lopez N,Patel R,Cheng G,Kita AZ,Andrien B

更新日期：2014-01-01 00:00:00

abstract：:The Annual bioProcessUK Conference has acted as the key networking event for bioprocess scientists and engineers in the UK for the past 10 years. The following article is a report from the sessions that focused on continuous bioprocessing during the 10(th) Annual bioProcessUK Conference (London, December 2013). These ...

journal_title：mAbs

authors： Farid SS,Thompson B,Davidson A

更新日期：2014-01-01 00:00:00

abstract：:High titer (>10 g/L) monoclonal antibody (mAb) cell culture processes are typically achieved by maintaining high viable cell densities over longer culture durations. A corresponding increase in the solids and sub-micron cellular debris particle levels are also observed. This higher burden of solids (≥15%) and sub-micr...

journal_title：mAbs

authors： McNerney T,Thomas A,Senczuk A,Petty K,Zhao X,Piper R,Carvalho J,Hammond M,Sawant S,Bussiere J

更新日期：2015-01-01 00:00:00

abstract：:Neutralizing antibody responses to the surface glycoproteins of enveloped viruses play an important role in immunity. Many of these glycoproteins, including the severe acute respiratory syndrome-coronavirus (SARS-CoV) spike (S) protein form trimeric units in the membrane of the native virion. There is substantial expe...

journal_title：mAbs

authors： Berry JD,Hay K,Rini JM,Yu M,Wang L,Plummer FA,Corbett CR,Andonov A

更新日期：2010-01-01 00:00:00

abstract：:A mono-specific antibody may recruit a second antigen binding specificity, thus converting to a dual-specific Two-in-One antibody through mutation at the light chain complementarity-determining regions (CDRs). It is, however, unknown whether mutation at the heavy chain CDRs may evolve such dual specificity. Herein, we...

journal_title：mAbs

authors： Lee CV,Koenig P,Fuh G

更新日期：2014-05-01 00:00:00

abstract：:Ricin is a toxin that could potentially be used as a bioweapon. We identified anti-ricin A chain antibodies by sequencing the antibody repertoire from immunized mice and by selecting high affinity antibodies using yeast surface display. These methods led to the isolation of multiple antibodies with high (sub-nanomolar...

journal_title：mAbs

authors： Wang B,Lee CH,Johnson EL,Kluwe CA,Cunningham JC,Tanno H,Crooks RM,Georgiou G,Ellington AD

更新日期：2016-08-01 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：:There are currently ~25 recombinant full-length IgGs (rIgGs) in the market that have been approved by regulatory agencies as biotherapeutics to treat various human diseases. Most of these are based on IgG1k framework and are either chimeric, humanized or human antibodies manufactured using either Chinese hamster ovary...

journal_title：mAbs

authors： Raju TS,Jordan RE

更新日期：2012-05-01 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：: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

abstract：:Tandem single-chain variable fragment (scFv) bispecific antibodies (bsAb) are one of the most promising bsAb formats reported thus far. Yet, because of their increased aggregation propensity, high impurity content due to low expression level, smaller size and lack of the Fc region, it is challenging to isolate these p...

journal_title：mAbs

authors： Chen SW,Tan D,Yang YS,Zhang W

更新日期：2020-01-01 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：:Glycosylation is a critical attribute for development and manufacturing of therapeutic monoclonal antibodies (mAbs) in the pharmaceutical industry. Conventional antibody glycan analysis is usually achieved by the 2-aminobenzamide (2-AB) hydrophilic interaction liquid chromatography (HILIC) method following the release...

journal_title：mAbs

authors： Yang X,Kim SM,Ruzanski R,Chen Y,Moses S,Ling WL,Li X,Wang SC,Li H,Ambrogelly A,Richardson D,Shameem M

更新日期：2016-05-01 00:00:00

abstract：:Highly concentrated antibody solutions often exhibit high viscosities, which present a number of challenges for antibody-drug development, manufacturing and administration. The antibody sequence is a key determinant for high viscosity of highly concentrated solutions; therefore, a sequence- or structure-based tool tha...

journal_title：mAbs

authors： Agrawal NJ,Helk B,Kumar S,Mody N,Sathish HA,Samra HS,Buck PM,Li L,Trout BL

更新日期：2016-01-01 00:00:00

abstract：:Respiratory syncytial virus (RSV) is a common cause of acute lower respiratory disease in infants and young children worldwide. Currently, treatment is supportive and no vaccines are available. The use of newborn lambs to model hRSV infection in human infants may provide a valuable tool to assess safety and efficacy o...

journal_title：mAbs

authors： Larios Mora A,Detalle L,Gallup JM,Van Geelen A,Stohr T,Duprez L,Ackermann MR

更新日期：2018-07-01 00:00:00