Clinical considerations for the development of biosimilars in oncology.

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 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：: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：: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：: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：:Immunoglobulins and T cell receptors (TCRs) share common sequences and structures. With the goal of creating novel bispecific antibodies (BsAbs), we generated chimeric molecules, denoted IgG_TCRs, where the Fv regions of several antibodies were fused to the constant domains of the α/β TCR. Replacing CH1 with Cα and CL...

journal_title：mAbs

authors： Wu X,Sereno AJ,Huang F,Zhang K,Batt M,Fitchett JR,He D,Rick HL,Conner EM,Demarest SJ

更新日期：2015-01-01 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：: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：: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：:The epidermal growth factor receptor (EGFR) is frequently dysregulated in human malignancies and a validated target for cancer therapy. Two monoclonal anti-EGFR antibodies (cetuximab and panitumumab) are approved for clinical use. However, the percentage of patients responding to treatment is low and many patients exp...

journal_title：mAbs

authors： Koefoed K,Steinaa L,Søderberg JN,Kjær I,Jacobsen HJ,Meijer PJ,Haurum JS,Jensen A,Kragh M,Andersen PS,Pedersen MW

更新日期：2011-11-01 00:00:00

abstract：:Animal cell culture technology has advanced significantly over the last few decades and is now generally considered a reliable, robust and relatively mature technology. A range of biotherapeutics are currently synthesized using cell culture methods in large scale manufacturing facilities that produce products for both...

journal_title：mAbs

authors： Li F,Vijayasankaran N,Shen AY,Kiss R,Amanullah A

更新日期：2010-09-01 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：: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：: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：: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：: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：:Colorectal cancer represents the second most common cause of cancer-related death. The human A33 transmembrane glycoprotein is a validated tumor-associated antigen, expressed in 95% of primary and metastatic colorectal cancers. Using phage display technology, we generated a human monoclonal antibody (termed A2) specif...

journal_title：mAbs

authors： Murer P,Plüss L,Neri D

更新日期：2020-01-01 00:00:00

abstract：:Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies...

journal_title：mAbs

authors： Scheinberg M,Pineda C,Castañeda-Hernández G,Zarbá JJ,Damião A,Arantes LH Jr,Jacobs I

更新日期：2018-08-01 00:00:00

abstract：:Antibodies are routinely used to study the activity of transcription factors, using various in vitro and in vivo approaches such as electrophoretic mobility shift assay, enzyme-linked immunosorbent assay, genome-wide method analysis coupled with next generation sequencing, or mass spectrometry. More recently, a new ap...

journal_title：mAbs

authors： Fontaine FR,Goodall S,Prokop JW,Howard CB,Moustaqil M,Kumble S,Rasicci DT,Osborne GW,Gambin Y,Sierecki E,Jones ML,Zuegg J,Mahler S,Francois M

更新日期：2018-05-01 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：:Monoclonal antibodies (mAbs) against human proteins are the primary protein capture reagents for basic research, diagnosis, and molecular therapeutics. The 2 most important attributes of mAbs used in all of these applications are their specificity and avidity. While specificity of a mAb raised against a human protein ...

journal_title：mAbs

authors： Liu S,Zhang H,Dai J,Hu S,Pino I,Eichinger DJ,Lyu H,Zhu H

更新日期：2015-01-01 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：: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 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：: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：: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：: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：:The linear pharmacokinetics (PK) of therapeutic monoclonal antibodies (mAbs) can be considered a class property with values that are similar to endogenous IgG. Knowledge of these parameters across species could be used to avoid unnecessary in vivo PK studies and to enable early PK predictions and pharmacokinetic/pharm...

journal_title：mAbs

authors： Betts A,Keunecke A,van Steeg TJ,van der Graaf PH,Avery LB,Jones H,Berkhout J

更新日期：2018-07-01 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：: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