Assessment of Structural and Functional Comparability of Biosimilar Products: Trastuzumab as a Case Study

Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab

(2019) Katariina M. Hutterer et al.   BIODRUGS

Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses

(2018) Jihun Lee et al.   mAbs

BeStSel: a web server for accurate protein secondary structure prediction and fold recognition from the circular dichroism spectra

(2018) András Micsonai et al.   NUCLEIC ACIDS RESEARCH

Charge variant native mass spectrometry benefits mass precision and dynamic range of monoclonal antibody intact mass analysis

(2018) Aaron O. Bailey et al.   mAbs

Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study

(2017) Neh Nupur et al.   mAbs

Modulating IgG effector function by Fc glycan engineering

(2017) Tiezheng Li et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Orthogonal Assessment of Biotherapeutic Glycosylation: A Case Study Correlating N-Glycan Core Afucosylation of Herceptin with Mechanism of Action

(2016) Rosie Upton et al.   ANALYTICAL CHEMISTRY

Glycosylation of monoclonal antibody products: Current status and future prospects

(2016) Jyoti Batra et al.   BIOTECHNOLOGY PROGRESS

Should charge variants of monoclonal antibody therapeutics be considered critical quality attributes?

(2016) Sumit Kumar Singh et al.   ELECTROPHORESIS

N-glycosylation heterogeneity and the influence on structure, function and pharmacokinetics of monoclonal antibodies and Fc fusion proteins

(2016) Fabian Higel et al.   EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS

A novel method for evaluating antibody-dependent cell-mediated cytotoxicity by flowcytometry using cryopreserved human peripheral blood mononuclear cells

(2016) Makiko Yamashita et al.   Scientific Reports

Batch-to-batch N-glycosylation study of infliximab, trastuzumab and bevacizumab, and stability study of bevacizumab

(2016) Ana Planinc et al.   European Journal of Hospital Pharmacy-Science and Practice

Sialylation of IgG Fc domain impairs complement-dependent cytotoxicity

(2015) Isaak Quast et al.   JOURNAL OF CLINICAL INVESTIGATION

Improving Trastuzumab’s Stability Profile by Removing the Two Degradation Hotspots

(2015) Yuemei Yang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

N-glycosylation profile analysis of Trastuzumab biosimilar candidates by Normal Phase Liquid Chromatography and MALDI-TOF MS approaches

(2015) Ivan Sanchez-De Melo et al.   Journal of Proteomics

Obtaining information about protein secondary structures in aqueous solution using Fourier transform IR spectroscopy

(2015) Huayan Yang et al.   Nature Protocols

Physicochemical and Biological Characterization of a Biosimilar Trastuzumab

(2015) Carlos A. López-Morales et al.   Biomed Research International

Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization

(2015) Mariana P. Miranda-Hernández et al.   Biomed Research International

Characterization and screening of IgG binding to the neonatal Fc receptor

(2014) Tobias Neuber et al.   mAbs

Regulation of complement and modulation of its activity in monoclonal antibody therapy of cancer

(2014) Saskia Meyer et al.   mAbs

Therapeutic protein aggregation: mechanisms, design, and control

(2014) Christopher J. Roberts   TRENDS IN BIOTECHNOLOGY

Rapid and multi-level characterization of trastuzumab using sheathless capillary electrophoresis-tandem mass spectrometry

(2013) Rabah Gahoual et al.   mAbs

Trastuzumab: Updated Mechanisms of Action and Resistance in Breast Cancer

(2012) Thuy Vu et al.   Frontiers in Oncology

High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

N-terminal Glutamate to Pyroglutamate Conversionin Vivofor Human IgG2 Antibodies

(2011) Y. Diana Liu et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

6thAnnual European Antibody Congress 2010

(2011) Alain Beck et al.   mAbs

Conformational stability and aggregation of therapeutic monoclonal antibodies studied with ANS and Thioflavin T binding

(2011) Veysel Kayser et al.   mAbs

Charge variants in IgG1

(2010) Leslie A. Khawli et al.   mAbs

Clinical comparability and European biosimilar regulations

(2010) Huub Schellekens et al.   NATURE BIOTECHNOLOGY

C-terminal lysine variants in fully human monoclonal antibodies: Investigation of test methods and possible causes

(2008) Lawrence W. Dick et al.   BIOTECHNOLOGY AND BIOENGINEERING

Effects of glycosylation on the stability of protein pharmaceuticals

(2008) Ricardo J. Solá et al.   JOURNAL OF PHARMACEUTICAL SCIENCES