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In Vitro Glycoengineering of IgG1 and Its Effect on Fc Receptor Binding and ADCC Activity
The importance and effect of Fc glycosylation of monoclonal antibodies with regard to biological activity is widely discussed and has been investigated in numerous studies. Fc glycosylation ofExpand
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Novel human IgG1 and IgG4 Fc-engineered antibodies with completely abolished immune effector functions.
Recombinant human IgG antibodies (hIgGs) completely devoid of binding to Fcγ receptors (FcγRs) and complement protein C1q, and thus with abolished immune effector functions, are of use for variousExpand
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Cell type-specific and site directed N-glycosylation pattern of FcγRIIIa.
Human leukocyte receptor IIIa (hFcγRIIIa) plays a prominent role in the elimination of tumor cells by antibody-based cancer therapies. In previous studies, a major impact of the presence ofExpand
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Multi-Angle Effector Function Analysis of Human Monoclonal IgG Glycovariants
Therapeutic performance of recombinant antibodies relies on two independent mechanisms: antigen recognition and Fc-mediated antibody effector functions. Interaction of Fc-fragment with different FcRExpand
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Analytical FcRn affinity chromatography for functional characterization of monoclonal antibodies
The neonatal Fc receptor (FcRn) is important for the metabolic fate of IgG antibodies in vivo. Analysis of the interaction between FcRn and IgG in vitro might provide insight into the structural andExpand
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Functional assessment of antibody oxidation by native mass spectrometry
Oxidation of methionine (Met) residues is one of several chemical degradation pathways for recombinant IgG1 antibodies. Studies using several methodologies have indicated that Met oxidation in theExpand
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A Two-pronged Binding Mechanism of IgG to the Neonatal Fc Receptor Controls Complex Stability and IgG Serum Half-life*
The success of recombinant monoclonal immunoglobulins (IgG) is rooted in their ability to target distinct antigens with high affinity combined with an extraordinarily long serum half-life, typicallyExpand
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Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions
The quality control testing of chemical degradations in the bio-pharmaceutical industry is currently under controversial debate. Here we have systematically applied in vitro and in vivo stressExpand
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Determination of critical quality attributes for monoclonal antibodies using quality by design principles.
TLDR
Quality by design is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. Expand
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Assessment of chemical modifications of sites in the CDRs of recombinant antibodies
Modifications like asparagine deamidation, aspartate isomerization, methionine oxidation, and lysine glycation are typical degradations for recombinant antibodies. For the identification andExpand
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