Drifts in N-Linked Glycosylation Result in ADCC Potency Variation of Perjeta® from August 2020 to October 2021 in China

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology

(2020) Liqi Xie et al.   BIODRUGS

Physicochemical and Biological Characterization of RTXM83, a New Rituximab Biosimilar

(2019) María L. Cerutti et al.   BIODRUGS

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

(2019) Katariina M. Hutterer et al.   BIODRUGS

Evaluation of survival by ADCC status: Subgroup analysis of SB3 (Trastuzumab Biosimilar) and reference trastuzumab in patients with HER2-positive early breast cancer at three-year follow-up.

(2019) Xavier Pivot et al.   JOURNAL OF CLINICAL ONCOLOGY

Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment

(2019) Jae Hee Lee et al.   BIODRUGS

Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2–positive breast cancer

(2019) Xavier Pivot et al.   EUROPEAN JOURNAL OF CANCER

Assessing the Heterogeneity of the Fc-Glycan of a Therapeutic Antibody Using an engineered FcγReceptor IIIa-Immobilized Column

(2018) Masato Kiyoshi et al.   Scientific Reports

Structural and functional characterization of MBS301, an afucosylated bispecific anti-HER2 antibody

(2018) Sijia Huang et al.   mAbs

Influence of N-glycosylation on effector functions and thermal stability of glycoengineered IgG1 monoclonal antibody with homogeneous glycoforms

(2018) Ryuta Wada et al.   mAbs

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

(2017) Seokkyun Kim et al.   mAbs

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

Fc-galactosylation modulates antibody-dependent cellular cytotoxicity of therapeutic antibodies

(2016) Marco Thomann et al.   MOLECULAR IMMUNOLOGY

Characterization of in vitro antibody-dependent cell-mediated cytotoxicity activity of therapeutic antibodies — Impact of effector cells

(2014) Shan Chung et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Identification and Characterization of Buried Unpaired Cysteines in a Recombinant Monoclonal IgG1 Antibody

(2012) Taylor Zhang et al.   ANALYTICAL CHEMISTRY

Structural basis for improved efficacy of therapeutic antibodies on defucosylation of their Fc glycans

(2011) Tsunehiro Mizushima et al.   GENES TO CELLS

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY