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Improving biophysical properties of a bispecific antibody scaffold to aid developability
While the concept of Quality-by-Design is addressed at the upstream and downstream process development stages, we questioned whether there are advantages to addressing the issues of biologics qualityExpand
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Mitochondrial disease genetic diagnostics: optimized whole-exome analysis for all MitoCarta nuclear genes and the mitochondrial genome.
Discovering causative genetic variants in individual cases of suspected mitochondrial disease requires interrogation of both the mitochondrial (mtDNA) and nuclear genomes. Whole-exome sequencing canExpand
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LC-MS characterization and purity assessment of a prototype bispecific antibody
Bispecific IgG asymmetric (heterodimeric) antibodies offer enhanced therapeutic efficacy, but present unique challenges for drug development. These challenges are related to the proper assembly ofExpand
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Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®
ABSTRACT Development of bio-therapeutics has exhibited exponential growth in China over the past decade. However, no biosimilar drug has been approved in China (CN) due to the lack of a nationalExpand
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Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology
A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes. The aim was toExpand
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Disulfide bond characterization of human factor Xa by mass spectrometry through protein‐level partial reduction
HighlightsProtein‐level partial reduction is proposed first time in complex disulfide linkage study.Disulfide bonds in Human Factor Xa are fully characterized first time by MS‐based method.PartialExpand
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Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®
Quality by design (QbD) is an efficient but challenging approach for the development of biosimilar due to the complex relationship among process, quality, and efficacy. Here, the analyticalExpand
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Solid State Lighting
Aleksandra B. Djurišić, Wang Hai, W. K. Chan, M. H. Xie, and S. Y. Tong The Dept. of Electrical&Electronic Engineering,The University of Hong Kong,Pokfulam Road,Hong Kong The Department of Physics,Expand
Characterization and elimination of artificial non-covalent light Chain dimers in reduced CE-SDS analysis of pertuzumab.
Capillary electrophoresis sodium dodecyl sulfate (CE-SDS), either in reduced (rCE-SDS) or non-reduced (nrCE-SDS) form, is widely used for purity evaluation and impurity analysis of monoclonalExpand