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In silico optimization of a challenging bispecific antibody chromatography step.
Biotechnol Prog
January 2025
Automation, Digital and Learning Solutions, Cytiva, Karlsruhe, Germany.
Mechanistic modeling of chromatographic steps is an effective tool in biopharma process development that enhances process understanding and accelerates optimization efforts and subsequent risk assessment. A relatively new model for ion exchange chromatography is the colloidal particle adsorption (CPA) formalism, which promises improved separation of material and molecule-specific parameters. This case study demonstrates a straightforward CPA modeling workflow to describe an ion exchange chromatography polishing step of a knobs-into-holes construct bispecific antibody molecule.
View Article and Find Full Text PDFDynamic Light Scattering Analysis of Lipid Nanoparticles: Effect of Salts on the Diffusion Interaction Parameter and Hydrodynamic Radius at Infinite Dilution.
Anal Chem
January 2025
School of Chemical Engineering, The University of Adelaide, North Terrace, Adelaide 5005, Australia.
The rise in the popularity of lipid nanoparticle (LNP)-based formulations necessitates the need for screening tools to quickly predict their colloidal stability in the presence of common excipients. Protein chemists have employed the diffusion interaction parameter () determined using dynamic light scattering as an indicator of formulation stability, yet this approach has not been applied to particulate systems. Herein, measurements of LNPs revealed behavior dissimilar to that of proteins.
View Article and Find Full Text PDFClinical value of saliva therapeutic drug monitoring of newer antiseizure medications.
Seizure
January 2025
Service and Laboratory of Clinical Pharmacology, University Hospital (CHUV) and Faculty of Biology and Medicine, Lausanne, Switzerland.
Introduction: Saliva is a promising option for therapeutic drug monitoring, with studies since the 1970s indicating a good correlation between plasma and saliva levels for early anti-seizure medications, although limited data exist for newer generation drugs.
Objectives: To evaluate the reliability and predictive power of saliva as a minimally invasive surrogate marker of plasma concentration for the routine therapeutic drug monitoring (TDM) of newer anti-seizure medications (ASM).
Methods: We collected blood samples at steady state in patients at least 6 h post-dose, paired with unstimulated saliva samples.
Validity of the Diabetic Wound Assessment Learning Tool.
Clin Teach
February 2025
Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Purpose: The development of the Diabetic Wound Assessment Learning Tool (DiWALT) has previously been described. However, an examination of its application to a larger, more heterogeneous group of participants is lacking. In order to allow for a more robust assessment of the psychometric properties of the DiWALT, we applied it to a broader group of participants.
View Article and Find Full Text PDFImplementation of Brief Submaximal Cardiopulmonary Testing in a High-Volume Pre-surgical Evaluation Clinic: A feasibility study.
JMIR Perioper Med
January 2025
Yale University, School of Medicine, Department of Anesthesiology, 333 Cedar StreetTMP-3, New Haven, US.
Background: Precise functional capacity assessment is a critical component for preoperative risk stratification. Brief submaximal cardiopulmonary exercise testing (smCPET) has shown diagnostic utility in various cardiopulmonary conditions. Objective: The objective of this study was to determine if smCPET could be implemented in a high-volume pre-surgical evaluation clinic, and, when compared to structured functional capacity surveys, if smCPET could better discriminate low functional capacity (<4.
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