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http://dx.doi.org/10.1128/jcm.01509-24 | DOI Listing |
Electrophoresis
September 2025
Therapeutics Development and Supply-Analytical Development, Janssen Research & Development, LLC, Malvern, Pennsylvania, USA.
Monoclonal antibodies (mAbs) present analytical challenges due to their inherent heterogeneity and susceptibility to post-translational modifications (PTMs) during production and storage. Monitoring of charge heterogeneity profiles by imaged capillary isoelectric focusing (icIEF) has been aided by the use of non-detergent sulfobetaines (NDSBs), particularly NDSB-211, to enhance protein solubility and stability. When used in a quality control laboratory setting, NDSB-211 has shown performance variability over time due to residual manufacturing impurities that impact the capillary isoelectric focusing separation.
View Article and Find Full Text PDFAAPS J
September 2025
Precision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.
CAR-T-cells can drive MHC class-I-mediated CD8 + cytotoxic T-cell response towards CAR constructs in addition to an antibody response. Immune response may also develop towards residuals present in the CAR-T cell product such as AAV, CRISPR/CAS9, and expamers. Health authorities recommend developing assays to assess both humoral and cellular immunogenicity towards the CAR-T protein.
View Article and Find Full Text PDFDrug Alcohol Rev
September 2025
Centre for Health Services Research, The University of Queensland, Brisbane, Australia.
Introduction: Unregulated anabolic-androgenic steroid (AAS) markets are a global phenomenon with significant variability in product composition and purity. This study aimed to determine the chemical composition of AAS sold in Australia.
Methods: This study analysed anonymously donated AAS samples.
Haemophilia
September 2025
Service d'Hématologie Biologique et d'Hémostase clinique, Hospices Civils De Lyon, UR4609 Université Claude Bernard Lyon 1, Lyon, France.
Introduction: Discrepancies in factor IX activity (FIX:C) measurements between one-stage clotting assays (OSAs) have been observed following infusion with recombinant factor IX extended half-life concentrates (EHL-rFIX) in the treatment of haemophilia B. These variations, primarily due to differences in activated partial thromboplastin time (APTT) reagents, complicate clinical decision-making.
Objectives: The aim of this study was to evaluate whether drug-specific calibrations for albumin-fused recombinant FIX (rFIX-FP) and Fc-fused recombinant FIX (rFIX-Fc) could reduce inter-reagent discrepancies.
PLoS One
September 2025
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University School of Medicine, Richmond, Virginia, United States of America.
Objective: Secondhand smoke (SHS) exposure has been implicated as a risk factor for hearing loss. However, there is a relative paucity of inconsistent findings with limited frequency-specific details. The goal of this study is to better characterize the relationship between SHS exposure and hearing loss among adult nonsmokers in the U.
View Article and Find Full Text PDF