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Protein concentration and analyzing charge variants in a co-formulation comprising three monoclonal antibodies: A cation-exchange chromatography approach.
Int J Pharm
January 2025
BioDev Drug Product Development Department, WuXi Biologics, 190 Hedan Road, Shanghai 200131, China. Electronic address:
In the realm of therapeutic antibodies, co-formulations comprising two or more monoclonal antibodies (mAbs) have emerged as a promising strategy, offering enhanced treatment efficacy, improved efficiency, and prolonged intellectual property protection. These advantages have sparked significant interest among both patients and pharmaceutical companies. However, the quantification and analysis of individual mAbs within such co-formulations pose a substantial challenge due to their similar physicochemical properties.
View Article and Find Full Text PDFDevelopment of an Optimized LC-MS Workflow for Host Cell Protein Characterization to Support Upstream Process Development.
J Proteome Res
January 2025
Clinical and Health Sciences, University of South Australia, 5000 Adelaide, Australia.
Host cell proteins (HCPs) coexpressed during the production of biotherapeutics can affect the safety, efficacy, and stability of the final product. As such, monitoring HCP populations and amounts throughout the production and purification process is an essential part of the overall quality control framework. Mass spectrometry (MS) is used as an orthogonal method to enzyme-linked immunosorbent assays (ELISA) for the simultaneous identification and quantification of HCPs, particularly for the analysis of downstream processes.
View Article and Find Full Text PDFSimultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.
Bioanalysis
December 2024
ICON Bioanalytical Laboratories, Assen, The Netherlands.
Background: Commonly, ligand-binding platforms are being used for immunogenicity assessment, but with the recent advent of liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for protein quantification, this technology has become an alternative for the measurement of anti-drug antibodies (ADAs), when combined with an immunocapture step to extract them out of the biological sample.
Method: The monoclonal antibody adalimumab was immobilized on magnetic beads to isolate ADAs against this drug from serum samples. Multiple repetitions of immunopurification were used to minimize nonspecific binding and improve drug tolerance while maintaining sufficient recovery.
Retinal fluid quantification using a novel deep learning algorithm in patients treated with faricimab in the TRUCKEE study.
Eye (Lond)
December 2024
Notal Vision, Manassas, VA, USA.
Background: Investigate retinal fluid changes via a novel deep-learning algorithm in real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD).
Methods: Multicenter, retrospective chart review and optical coherence tomography (OCT) image upload from participating sites was conducted on patients treated with faricimab for nAMD from February 2022 to January 2024. The Notal OCT Analyzer (NOA) algorithm provided intraretinal, subretinal and total retinal fluid for each scan.
Frontline treatment of adults with newly diagnosed B-cell acute lymphoblastic leukaemia.
Lancet Haematol
December 2024
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Article Synopsis
- - In the last decade, significant advancements have been made in treating adults with newly diagnosed B-cell acute lymphoblastic leukaemia, driven by better understanding of the disease and innovative treatment strategies like incorporating immunotherapy and tyrosine kinase inhibitors.
- - Despite these advancements, adults still have worse outcomes compared to children, facing higher rates of treatment failure and complications, leading to ongoing use of transplant consolidation for high-risk cases.
- - The article emphasizes the need for new trial designs to further improve treatment strategies and personalize care for adults with acute lymphoblastic leukaemia, sharing insights from practices across Europe and other continents.
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