Enzymatic removal of sialic acid enables iCIEF stability monitoring of charge variants of a highly sialylated bispecific antibody
Sign Up to like & getrecommendations! Published in 2022 at "ELECTROPHORESIS"
DOI: 10.1002/elps.202100259
Abstract: Antibody‐based therapeutic proteins have highly complex molecular structures. The final therapeutic protein product may contain a wide range of charge variants. Accurate analysis of this charge variant composition is critical to determine manufacturing process consistency… read more here.
Keywords: highly sialylated; charge variants; sialylated bispecific; stability ... See more keywords
Rapid multi‐attribute characterization of intact bispecific antibodies by a microfluidic chip‐based integrated icIEF‐MS technology
Sign Up to like & getrecommendations! Published in 2022 at "Electrophoresis"
DOI: 10.1002/elps.202200165
Abstract: Rapid, direct identification and quantitation of protein charge variants, and assessment of critical quality attributes with high sensitivity are important drivers required to accelerate the development of biotherapeutics. We describe the use of an enhanced… read more here.
Keywords: chip based; microfluidic chip; charge variants; charge ... See more keywords
Identification of multiple sources of the acidic charge variants in an IgG1 monoclonal antibody
Sign Up to like & getrecommendations! Published in 2017 at "Applied Microbiology and Biotechnology"
DOI: 10.1007/s00253-017-8301-x
Abstract: Charge variants, especially acidic charge variants, of recombinant monoclonal antibodies are the major critical quality attributes in the biotechnology industry due to their potential influence on stability and biological activity. The chemical properties of the… read more here.
Keywords: multiple sources; acidic charge; charge variants; charge ... See more keywords
Human Fc receptor‐like 5 distinguishes IgG2 disulfide isoforms and deamidated charge variants
Sign Up to like & getrecommendations! Published in 2017 at "Molecular Immunology"
DOI: 10.1016/j.molimm.2017.10.020
Abstract: HighlightsFCRL5, unlike Fc‐receptors, discriminate IgG2 disulfide isoforms.FCRL5, unlike Fc‐receptors, discriminate IgG2 charge variants.IgG2 disulfide isoforms and charge variants could represent biological FCRL5 ligands.FCRL5 may belong to a new class of receptors which senses protein age.A… read more here.
Keywords: disulfide isoforms; charge variants; igg2 disulfide; fcrl5 ... See more keywords
Inter-laboratory study to evaluate the performance of automated online characterization of antibody charge variants by multi-dimensional LC-MS/MS.
Sign Up to like & getrecommendations! Published in 2021 at "Talanta"
DOI: 10.1016/j.talanta.2021.122628
Abstract: An international study was conducted to evaluate the performance and reliability of an online multi-dimensional (mD)-LC-MS/MS approach for the characterization of antibody charge variants. The characterization of antibody charge variants is traditionally performed by time-consuming,… read more here.
Keywords: charge variants; charge; study; antibody charge ... See more keywords
Assessing the Impact of Charge Variants on Stability and Viscosity of a High Concentration Antibody Formulation.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2017.08.016
Abstract: Characterizing molecular charge variants or isoforms is essential for understanding safety, potency, and bioavailability of antibody therapeutics. However, there is little information on how they influence stability and viscosity-properties governing immunogenicity and delivery. To bridge… read more here.
Keywords: charge variants; antibody; charge; stability viscosity ... See more keywords
Comprehensive Multidimensional Liquid Chromatography–Mass Spectrometry for the Characterization of Charge Variants of a Bispecific Antibody
Sign Up to like & getrecommendations! Published in 2022 at "Journal of the American Society for Mass Spectrometry"
DOI: 10.1021/jasms.2c00296
Abstract: Identification and further characterization of antibody charge variants is a crucial step during biopharmaceutical drug development, particularly with regard to the increasing complexity of novel antibody formats. As a standard analytical approach, manual offline fractionation… read more here.
Keywords: mass spectrometry; characterization; antibody; charge variants ... See more keywords
Challenges and Strategies for a Thorough Characterization of Antibody Acidic Charge Variants
Sign Up to like & getrecommendations! Published in 2022 at "Bioengineering"
DOI: 10.3390/bioengineering9110641
Abstract: Heterogeneity of therapeutic Monoclonal antibody (mAb) drugs are due to protein variants generated during the manufacturing process. These protein variants can be critical quality attributes (CQAs) depending on their potential impact on drug safety and/or… read more here.
Keywords: charge variants; characterization; thorough characterization; acidic variants ... See more keywords
Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties.
Sign Up to like & getrecommendations! Published in 2023 at "Iranian biomedical journal"
DOI: 10.52547/ibj.3837
Abstract: Background Post-translational modifications in bioprocessing and storage of recombinant mAbs are the main sources of charge variants. While the profile of these kinds of variants is considered an important quality attribute of therapeutic mAbs, there… read more here.
Keywords: study physicochemical; charge variants; physicochemical pharmacokinetic; variants study ... See more keywords