Evaluating imbalances of adverse events during biosimilar development.

abstract：:Monomeric IgA has been proposed as an alternative antibody format for cancer therapy. Here, we present our studies on the production, purification and functional evaluation of anti-HER2 IgA antibodies as anti-cancer agents in comparison to the anti-HER2 IgG1 trastuzumab. MALDI-TOF MS analysis showed profound differenc...

journal_title：mAbs

authors： Rouwendal GJ,van der Lee MM,Meyer S,Reiding KR,Schouten J,de Roo G,Egging DF,Leusen JH,Boross P,Wuhrer M,Verheijden GF,Dokter WH,Timmers M,Ubink R

更新日期：2016-01-01 00:00:00

abstract：:The current standard treatment for acute myeloid leukemia (AML) is chemotherapy based on cytarabine and daunorubicine (7 + 3), but it discriminates poorly between malignant and benign cells. Dose-limiting off‑target effects and intrinsic drug resistance result in the inefficient eradication of leukemic blast cells and...

journal_title：mAbs

authors： Fitting J,Blume T,Ten Haaf A,Blau W,Gattenlöhner S,Tur MK,Barth S

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：: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：:Antibody-drug conjugates (ADCs) represent a new class of cancer therapeutics. Their design involves a tumor-specific antibody, a linker and a cytotoxic payload. They were designed to allow specific targeting of highly potent cytotoxic agents to tumor cells whilst sparing normal cells. Frequent toxicities that may be d...

journal_title：mAbs

authors： Donaghy H

更新日期：2016-05-01 00:00:00

abstract：:Bispecific antibodies can uniquely influence cellular responses, but selecting target combinations for optimal functional activity remains challenging. Here we describe a high-throughput, combinatorial, phenotypic screening approach using a new bispecific antibody target discovery format, allowing screening of hundred...

journal_title：mAbs

authors： Bhatta P,Whale KD,Sawtell AK,Thompson CL,Rapecki SE,Cook DA,Twomey BM,Mennecozzi M,Starkie LE,Barry EMC,Peters SJ,Kamal AM,Finney HM

更新日期：2021-01-01 00:00:00

abstract：:MPDL3280A is a human monoclonal antibody that targets programmed cell death-1 ligand 1 (PD-L1), and exerts anti-tumor activity mainly by blocking PD-L1 interaction with programmed cell death-1 (PD-1) and B7.1. It is being investigated as a potential therapy for locally advanced or metastatic malignancies. The purpose ...

journal_title：mAbs

authors： Deng R,Bumbaca D,Pastuskovas CV,Boswell CA,West D,Cowan KJ,Chiu H,McBride J,Johnson C,Xin Y,Koeppen H,Leabman M,Iyer S

更新日期：2016-01-01 00:00:00

abstract：:Ectodomains of target antigens for antibody-based therapies can be shed from the target cell surface and found in sera of patients. Shed ectodomains of therapeutic targets not only pose the risk of sequestering therapeutic antibodies but, in a multimeric form, of triggering T cell activation by bispecific antibodies b...

journal_title：mAbs

authors： Petsch S,Gires O,Rüttinger D,Denzel S,Lippold S,Baeuerle PA,Wolf A

更新日期：2011-01-01 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：:Self-interaction of an antibody may lead to aggregation, low solubility or high viscosity. Rapid identification of highly developable leads remains challenging, even though progress has been made with the introduction of techniques such as self-interaction chromatography (SIC) and cross-interaction chromatography (CIC...

journal_title：mAbs

authors： Sun T,Reid F,Liu Y,Cao Y,Estep P,Nauman C,Xu Y

更新日期：2013-11-01 00:00:00

abstract：:Monoclonal antibody (mAb) candidates from high-throughput screening or binding affinity optimization often contain mutations leading to liabilities for further development of the antibody, such as aggregation-prone regions and lack of solubility. In this work, we optimized a candidate integrin α11-binding mAb for deve...

journal_title：mAbs

authors： Jetha A,Thorsteinson N,Jmeian Y,Jeganathan A,Giblin P,Fransson J

更新日期：2018-08-01 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：: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：: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：:Hepatitis B virus (HBV) produces large (L), middle (M), and small (S) envelope proteins, alternatively referred to as hepatitis B surface antigen (HBsAg). Currently, yeast-derived S protein serves as the preventive vaccine, while hepatitis B immune globulin (HBIG) concentrated from pooled plasma of vaccine recipients ...

journal_title：mAbs

authors： Wang W,Sun L,Li T,Ma Y,Li J,Liu Y,Li M,Wang L,Li C,Xie Y,Wen Y,Liang M,Chen L,Tong S

更新日期：2016-01-01 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：: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：: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：: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：:Severe forms of dengue virus (DENV) infection frequently cause high case fatality rate. Currently, there is no effective vaccine against the infection. Clinical cases are given only palliative treatment as specific anti-DENV immunotherapy is not available and it is urgently required. In this study, human single-chain ...

journal_title：mAbs

authors： Poungpair O,Bangphoomi K,Chaowalit P,Sawasdee N,Saokaew N,Choowongkomon K,Chaicumpa W,Yenchitsomanus PT

更新日期：2014-03-01 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：:While many antibody therapeutics are formulated at low concentration (~10-20 mg/mL) for intravenous administration, high concentration (> 100 mg/mL) formulations may be required for subcutaneous delivery in certain clinical indications. For such high concentration formulations, product color is more apparent due to th...

journal_title：mAbs

authors： Derfus GE,Dizon-Maspat J,Broddrick JT,Velayo AC,Toschi JD,Santuray RT,Hsu SK,Winter CM,Krishnan R,Amanullah A

更新日期：2014-05-01 00:00:00

abstract：:Gel microdroplet - fluorescence activated cell sorting (GMD-FACS) is an innovative high throughput screening platform for recombinant protein libraries, and we show here that GMD-FACS can overcome many of the limitations associated with conventional screening methods for antibody libraries. For example, phage and cell...

journal_title：mAbs

authors： Fang Y,Chu TH,Ackerman ME,Griswold KE

更新日期：2017-11-01 00:00:00

abstract：:The development and production of recombinant monoclonal antibodies is well established. Although most of these are IgGs, there is also great interest in producing recombinant IgAs since this isotype plays a critical role in providing immunologic protection at mucosal surfaces. The choice of expression system for prod...

journal_title：mAbs

authors： Yoo EM,Yu LJ,Wims LA,Goldberg D,Morrison SL

更新日期：2010-05-01 00:00:00

abstract：:High physical stability is required for the development of monoclonal antibodies (mAbs) into successful therapeutic products. Developability assays are used to predict physical stability issues such as high viscosity and poor conformational stability, but protein aggregation remains a challenging property to predict. ...

journal_title：mAbs

authors： Kopp MRG,Wolf Pérez AM,Zucca MV,Capasso Palmiero U,Friedrichsen B,Lorenzen N,Arosio P

更新日期：2020-01-01 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：: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：:The importance of the neonatal Fc receptor (FcRn) in extending the serum half-life of monoclonal antibodies (mAbs) is well demonstrated, and has led to the development of multiple engineering approaches designed to alter Fc interactions with FcRn. Recent reports have additionally highlighted the effect of nonspecific ...

journal_title：mAbs

authors： Kelly RL,Yu Y,Sun T,Caffry I,Lynaugh H,Brown M,Jain T,Xu Y,Wittrup KD

更新日期：2016-10-01 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：: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