Biomanufacturing evolution from conventional to intensified processes for productivity improvement: a case study.

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：: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：:Several angiogenesis inhibitors targeting the vascular endothelial growth factor (VEGF) signaling pathway have been approved for cancer treatment. However, VEGF inhibitors alone were shown to promote tumor invasion and metastasis by increasing intratumoral hypoxia in some preclinical and clinical studies. Emerging rep...

journal_title：mAbs

authors： Lee D,Kim D,Choi YB,Kang K,Sung ES,Ahn JH,Goo J,Yeom DH,Jang HS,Moon KD,Lee SH,You WK

更新日期：2016-07-01 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：:The aim of this study was to investigate neonatal Fc receptor (FcRn) concentration developmental pharmacology in adult and pediatric subjects using minimal physiologically-based pharmacokinetic (mPBPK) modelling. Three types of pharmacokinetic (PK) data for three agents (endogenous/exogenous native IgG, bevacizumab an...

journal_title：mAbs

authors： Hardiansyah D,Ng CM

更新日期：2018-10-01 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：:Recombinant antibody single-chain variable fragments (scFv) are difficult to purify homogeneously from a protein complex mixture. The most effective, specific and fastest method of purification is an affinity chromatography on Protein L (PpL) matrix. This protein is a multi-domain bacterial surface protein that is abl...

journal_title：mAbs

authors： Lakhrif Z,Pugnière M,Henriquet C,di Tommaso A,Dimier-Poisson I,Billiald P,Juste MO,Aubrey N

更新日期：2016-01-01 00:00:00

abstract：:Site-specific antibody-drug conjugates (ADCs) are designed to overcome the heterogeneity observed with first-generation ADCs that use random conjugation to surface-exposed lysine residues or conjugation to interchain disulfide bonds. Despite significantly enhanced homogeneity, however, the production of site-specific ...

journal_title：mAbs

authors： Cao M,De Mel N,Jiao Y,Howard J,Parthemore C,Korman S,Thompson C,Wendeler M,Liu D

更新日期：2019-08-01 00:00:00

abstract：:Although extensively studied, protein-protein interactions remain highly elusive and are of increasing interest in drug development. We show the assembly of a monoclonal antibody, using multivalent carboxylate ions, into highly-ordered structures. While the presence and function of similar structures in vivo are not k...

journal_title：mAbs

authors： Esue O,Xie AX,Kamerzell TJ,Patapoff TW

更新日期：2013-03-01 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：: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 B cell antigen receptor repertoire is highly diverse and constantly modified by clonal selection. High-throughput DNA sequencing (HTS) of the lymphocyte repertoire (Rep-Seq) represents a promising technology to explore such diversity ex-vivo and assist in the identification of antigen-specific antibodies based on ...

journal_title：mAbs

authors： Cortina-Ceballos B,Godoy-Lozano EE,Sámano-Sánchez H,Aguilar-Salgado A,Velasco-Herrera Mdel C,Vargas-Chávez C,Velázquez-Ramírez D,Romero G,Moreno J,Téllez-Sosa J,Martínez-Barnetche J

更新日期：2015-01-01 00:00:00

abstract：:The advantages of site-specific over stochastic bioconjugation technologies include homogeneity of product, minimal perturbation of protein structure/function, and - increasingly - the ability to perform structure activity relationship studies at the conjugate level. When selecting the optimal location for site-specif...

journal_title：mAbs

authors： Huang BCB,Kim YC,Bañas S,Barfield RM,Drake PM,Rupniewski I,Haskins WE,Rabuka D

更新日期：2018-11-01 00:00:00

abstract：:Therapeutic antibodies continue to develop as an emerging drug class, with a need for preclinical tools to better predict in vivo characteristics. Transgenic mice expressing human neonatal Fc receptor (hFcRn) have potential as a preclinical pharmacokinetic (PK) model to project human PK of monoclonal antibodies (mAbs)...

journal_title：mAbs

authors： Avery LB,Wang M,Kavosi MS,Joyce A,Kurz JC,Fan YY,Dowty ME,Zhang M,Zhang Y,Cheng A,Hua F,Jones HM,Neubert H,Polzer RJ,O'Hara DM

更新日期：2016-08-01 00:00:00

abstract：:Although there are currently more than 30 antibody-drug conjugates (ADC) in clinical development for the treatment of blood cancers and solid tumors, comparison of their clinical pharmacokinetics (PK) is challenging because of the large number of, and differences between, the targets, ADC constructs, dosing regimens, ...

journal_title：mAbs

authors： Deslandes A

更新日期：2014-07-01 00:00:00

abstract：:Monoclonal antibodies are widely used for the treatment of cancer, inflammatory and infectious diseases and other disorders. Most of the marketed antibodies are monospecific and therefore capable of interacting and interfering with a single target. However, complex diseases are often multifactorial in nature, and invo...

journal_title：mAbs

authors： Kontermann RE

更新日期：2012-03-01 00:00:00

abstract：:Genetically encoded fluorescent antibodies are desirable for many applications in biotechnology, proteomics, microscopy, cell biology and molecular diagnostics, although efficient production of fluorescent IgGs in mammalian cells has been hampered by different and mutually incompatible secretion- and folding-requireme...

journal_title：mAbs

authors： Haas AK,von Schwerin C,Matscheko D,Brinkmann U

更新日期：2010-11-01 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：: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：:Due to their excellent specificity for a single epitope, monoclonal antibodies (mAbs) present a means of influencing the function of cells at the molecular level. In particular they show great promise in the treatment of cancer because they can inhibit cancer cell proliferation, tumor angiogenesis, invasiveness and ma...

journal_title：mAbs

authors： Julien DC,Behnke S,Wang G,Murdoch GK,Hill RA

更新日期：2011-09-01 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：:Fusion proteins combining oligomeric assemblies of a genetically obtained single-chain (sc) variant of tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) with antibodies directed against tumor-associated antigens represent a promising strategy to overcome the limited therapeutic activity of conventional s...

journal_title：mAbs

authors： Siegemund M,Seifert O,Zarani M,Džinić T,De Leo V,Göttsch D,Münkel S,Hutt M,Pfizenmaier K,Kontermann RE

更新日期：2016-07-01 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：: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：: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：: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：:Certolizumab pegol (Cimzia(®)) is currently the only PEGylated anti-TNFα biologic approved for the treatment of rheumatoid arthritis and Crohn disease. The product, developed by UCB, is a humanized antigen-binding fragment (Fab') of a monoclonal antibody that has been conjugated to polyethylene glycol. Certolizumab pe...

journal_title：mAbs

authors： Goel N,Stephens S

更新日期：2010-03-01 00:00:00

abstract：:Therapeutic monoclonal antibodies (mAbs) are highly complex proteins that must be exhaustively characterized according to the regulatory authorities' recommendations. MAbs display micro-heterogeneity mainly due to their post-translational modifications, but also to their susceptibility to chemical and physical degrada...

journal_title：mAbs

authors： Rouby G,Tran NT,Leblanc Y,Taverna M,Bihoreau N

更新日期：2020-01-01 00:00:00

abstract：:Fragmentation in the hinge region of an IgG1 monoclonal antibody (mAb) can affect product stability, potentially causing changes in potency and efficacy. Metals ions, such as Cu(2+), can bind to the mAb and undergo hydrolysis or oxidation, which can lead to cleavage of the molecule. To better understand the mechanism ...

journal_title：mAbs

authors： Glover ZK,Basa L,Moore B,Laurence JS,Sreedhara A

更新日期：2015-01-01 00:00:00

abstract：:Immunotherapy approaches for Alzheimer disease currently are among the leading therapeutic directions for the disease. Active and passive immunotherapy against the beta-amyloid peptides that aggregate and accumulate in the brain of those afflicted by the disease have been shown by numerous groups to reduce plaque path...

journal_title：mAbs

authors： Gouras GK

更新日期：2009-03-01 00:00:00