Key factors influencing ADME properties of therapeutic proteins: A need for ADME characterization in drug discovery and development
abstract Protein therapeutics represent a diverse array of biologics including antibodies,
fusion proteins, and therapeutic replacement enzymes. Since their inception, they have …
fusion proteins, and therapeutic replacement enzymes. Since their inception, they have …
In vitro and in vivo modifications of recombinant and human IgG antibodies
H Liu, G Ponniah, HM Zhang, C Nowak, A Neill… - MAbs, 2014 - Taylor & Francis
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 …
IgG antibodies, driven mainly by the fact that antibodies are one of the most important …
Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI …
D Ayoub, W Jabs, A Resemann, W Evers, C Evans… - MAbs, 2013 - Taylor & Francis
The European Medicines Agency received recently the first marketing authorization
application for a biosimilar monoclonal antibody (mAb) and adopted the final guidelines on …
application for a biosimilar monoclonal antibody (mAb) and adopted the final guidelines on …
A novel approach to investigate the effect of methionine oxidation on pharmacokinetic properties of therapeutic antibodies
J Stracke, T Emrich, P Rueger, T Schlothauer, L Kling… - MAbs, 2014 - Taylor & Francis
Preserving the chemical and structural integrity of therapeutic antibodies during
manufacturing and storage is a major challenge during pharmaceutical development …
manufacturing and storage is a major challenge during pharmaceutical development …
The interplay of non-specific binding, target-mediated clearance and FcRn interactions on the pharmacokinetics of humanized antibodies
A Datta-Mannan, J Lu, DR Witcher, D Leung, Y Tang… - MAbs, 2015 - Taylor & Francis
The application of protein engineering technologies toward successfully improving antibody
pharmacokinetics has been challenging due to the multiplicity of biochemical factors that …
pharmacokinetics has been challenging due to the multiplicity of biochemical factors that …
Correlations between changes in conformational dynamics and physical stability in a mutant IgG1 mAb engineered for extended serum half-life
R Majumdar, R Esfandiary, SM Bishop, HS Samra… - MAbs, 2015 - Taylor & Francis
This study compares the local conformational dynamics and physical stability of an IgG1
mAb (mAb-A) with its corresponding YTE (M255Y/S257T/T259E) mutant (mAb-E), which was …
mAb (mAb-A) with its corresponding YTE (M255Y/S257T/T259E) mutant (mAb-E), which was …
Consistency of quality attributes for the glycosylated monoclonal antibody Humira®(adalimumab)
PW Tebbey, A Varga, M Naill, J Clewell, J Venema - MAbs, 2015 - Taylor & Francis
Humira®(adalimumab) is a recombinant human IgG1 monoclonal antibody (mAb)
glycoprotein consisting of 1330 amino acids that is specific for human tumor necrosis factor …
glycoprotein consisting of 1330 amino acids that is specific for human tumor necrosis factor …
Aberrant bispecific antibody pharmacokinetics linked to liver sinusoidal endothelium clearance mechanism in cynomolgus monkeys
A Datta-Mannan, JE Croy, L Schirtzinger, S Torgerson… - MAbs, 2016 - Taylor & Francis
Bispecific antibodies (BsAbs) can affect multiple disease pathways, thus these types of
constructs potentially provide promising approaches to improve efficacy in complex disease …
constructs potentially provide promising approaches to improve efficacy in complex disease …
Conformational characterization of the charge variants of a human IgG1 monoclonal antibody using H/D exchange mass spectrometry
L Tang, S Sundaram, J Zhang, P Carlson, A Matathia… - MAbs, 2013 - Taylor & Francis
MAb1, a human IgG1 monoclonal antibody produced in a NS0 cell line, exhibits charge
heterogeneity because of the presence of variants formed by processes such as N-terminal …
heterogeneity because of the presence of variants formed by processes such as N-terminal …
A novel in vitro assay to predict neonatal Fc receptor-mediated human IgG half-life
CA Souders, SC Nelson, Y Wang, AR Crowley… - MAbs, 2015 - Taylor & Francis
Immunoglobulin G (IgG) has an unusually long serum half-life in comparison to proteins of a
similar size. It is well-known that this phenomenon is due to IgG's ability to bind the neonatal …
similar size. It is well-known that this phenomenon is due to IgG's ability to bind the neonatal …