Lea Bonnington

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To monitor the Fc glycosylation of therapeutic immunoglobulin G in bioprocess development, product characterization and release analytics, reliable techniques for glycosylation analysis are needed. Several analytical methods are suitable for this application. We recently presented results comparing detection methods for glycan analysis that are(More)
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 the constant IgG1 domains affects in vitro interaction with human neonatal Fc (huFcRn) receptor, which is important for antibody half-life. Here, a completely new(More)
Ten patients were treated for skin erosion and exposure of chronically implanted pacemakers. The pulse generators had been implanted either subcutaneously or in the subpectoral, submammary location. All patients were treated either by primary or secondary relocation of the pulse generator to deeper subfascial planes. Pacemakers relocated primarily to(More)
High-molecular weight aggregates such as antibody dimers and other side products derived from incorrect light or heavy chain association typically represent critical product-related impurities for bispecific antibody formats. In this study, an approach employing ultra-pressure liquid chromatography size-exclusion separation combined with native electrospray(More)
Protein-based pharmaceuticals represent the fastest growing group of drugs in development in the pharmaceutical industry. One of the major challenges in the discovery, development, and distribution of biopharmaceuticals is the assessment of changes in their higher-order structure due to chemical modification. Here, we investigated the interactions of three(More)
Valve replacement in patients with a small aortic anulus can cause difficult technical problems or leave the patient with a significant residual transvalvular gradient. Between August, 1977, and June, 1983, 35 patients with a small aortic root (21 mm or less) underwent aortic valve replacement with Ionescu-Shiley pericardial xenograft valves. They ranged in(More)
The usefulness of the higher-order structure information provided by hydrogen/deuterium exchange mass spectrometry (HDX-MS) in the protein therapeutic field is undisputed; however, its applicability as a method for critical quality and comparability assessment has until now not been demonstrated. Here we present results demonstrating for the first time the(More)
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