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Morphine (MO) as an opioid analgesic is used for the treatment of moderate-to-severe pains, particularly cancer-related pains. Pharmacologic studies on MO are complicated due to drugs binding to the protein or metabolization to active metabolites, and even inter-individual variability. This necessitates the selection of a reliable analytical method for monitoring MO and the concentrations of […]

Aim: 2-Hydroxyglutarate (2-HG) is a target engagement biomarker in patients after treatment with inhibitors of mutated isocitrate dehydrogenase (mIDH). Accurate measurement of 2-HG is critical for monitoring the inhibition effectiveness of the inhibitors. Materials & methods: Human plasma samples were spiked with stable isotope labelled internal standard, processed by protein precipitation, and analyzed using LC–MS/MS.

Aim: Volumetric absorptive microsampling offers a hematocrit insensitive way for microsampling. The aim of this study was to develop a method for routine healthcare for 14 antidepressants, antipsychotics and their active metabolites on a single-quadrupole HPLC–MS. A clinical validation study to determine conversion factors from capillary blood to plasma concentration was conducted afterward. Results: The

Outsourcing is a common strategy across the pharmaceutical industry and clinical research. CROs offer many choices for selecting outsourcing partners for bioanalytical and biomarker support. We aimed this paper to provide critical insights into CRO benchmarking and selection using a bioanalytical challenge approach performing fit-for-purpose ligand-binding assay. Bioanalytical challenge (method validation and sample analysis) offer

In this paper, the European Bioanalysis Forum reports back from the discussions with software developers, involved in regulated bioanalysis software solutions, on agreeing to data transfer specification in the bioanalytical labs’ LC–MS workflows as part of today’s Data Integrity (DI) challenges. The proposed specifications aim at identifying what consists of a minimum dataset, that is,

Immunogenicity testing is a mandatory and critical activity during the development of therapeutic proteins. Multiple regulatory guidelines provide clear recommendations on appropriate immunogenicity testing strategies and required bioanalytical assay performances. Unfortunately, it is still generally accepted that a comparison of the immunogenicity of different compounds is not possible due to apparent performance differences of the

Background: To streamline and improve throughput, the agar-based multiplexed opsonophagocytic killing assay (MOPA) was optimized and validated on a microcolony platform for use in the Phase III clinical trial program for V114, an MSD 15-valent pneumococcal conjugate vaccine candidate. Results & methodology: The precision, dilutional linearity and specificity of the microcolony MOPA (mMOPA) were assessed

Aim: To optimize clinical efficacy and reduce the drug-exposure-related toxicity of linezolid, whose concentrations show wide inter-variabilities, a simple and reliable quantitative assay for therapeutic drug monitoring is necessary. Results: A UHPLC–MS/MS assay has been established for determination of linezolid in human plasma and fully validated according to the US FDA guidelines. After a simple,

Aim: Iohexol plasma clearance is used as an indicator of kidney function in clinical and preclinical settings. To investigate the pharmacokinetic profile of iohexol, a rapid, simple method for measurement of iohexol in different matrices and species was needed. Materials & methods: Iohexol was separated on an Accucore C18 column (Thermo Fisher Scientific, CA, USA).

Aim: Antidrug antibody (ADA) assessment may be challenged in studies that involve the administration of high doses of biotherapeutics and/or with long half-lives. In such cases, ADA assays with optimized drug tolerance are desired. Material & Methods: We evaluated the use of MgCl2 to develop high ionic strength dissociation assays in two investigational examples (bridging