The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened […]
Aim: Methylmalonic acid (MMA) analysis in urine represents a noninvasive approach to screening for vitamin B12 deficiency in older adults. A method allowing the analysis of MMA/creatinine in fasting urine collected on filter paper was developed/validated. Method: Dry urine specimens were eluted using a solution containing internal standards, filtrated and analyzed by ultra-performance LC-MS/MS. Results:
Aim: Antisense oligonucleotides (ASOs) are a fast-growing drug modality. Pharmacokinetic characterization and accurate quantification of ASOs is critical for drug development. LC–MS and hybridization immunoassays are common methods to quantify ASOs but may lack sensitivity. In this study we aimed to develop an ASO quantification method with improved sensitivity. Methods: We developed a branched DNA
Background: Antisense oligonucleotide (ASO), an emerging modality in drug research and development, demands accurate and sensitive bioanalysis to understand its pharmacokinetic and pharmacodynamic properties. Results: By combining the advantages of both ligand binding and liquid chromatography-mass spectrometry/tandem mass (LC-MS/MS), hybridization LC-MS/MS methods were successfully developed and validated/qualified in a good lab practice (GLP) environment for
Aim: To develop a method for the quantitation of effector functionless mouse surrogate IgG1 drug molecules in mouse matrices. Materials & methods: A panel of antibodies that bound specifically to N297G mutation-containing mouse IgG molecules was generated in rats. The panel was screened to identify an antibody that could be used as both the capture
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened
In the Bioanalytical Challenge by Caroline Kittinger, Jared Delmar, Lisa Hewitt, Rebecca Holcomb, Christopher Jones, Hayden Jones, Robert Kubiak, Nancy Lee, L Claire McClenny, Neil Mody & Ellen O’Connor, titled ‘Critical reagents for ligand-binding assays: process development methodologies to enable high-quality reagents’ and published in the February 2022 issue of Bioanalysis (14[3], 117–135; DOI:10.4155/bio-2021-0217), the
Aim: To mitigate assay interference in the drug and target assays to support the development of monoclonal antibody REGN-Z. Results: Mild acidic assay conditions and capture and detection antibodies with different affinities and t1/2 under different assay pHs were used to mitigate interference in the total drug and total target assays. A free target assay
Background: Nonesterified, total docosahexaenoic acid (DHA) and eicosapenaenoic acid (EPA) plasma levels were evaluated in patients with schizophrenia on different medications compared with healthy individuals using validated LC-MS/MS methods. Methods: Samples for nonesterified DHA and EPA assay were extracted in n-hexane-dichloromethane-isopropyl alcohol (2:1:0.1, V/V/V) and hydrolyzed at 90°C for 2 h before total DHA and
Aim: IQZ23, a novel β-indoloquinazoline derivative, is a potential therapeutic agent for obesity and related metabolic disorders. To assist pharmacokinetics evaluation, a quantitative method for IQZ23 in rat plasma is required. Methods & Results: An LC-MS/MS assay for the determination of IQZ23 in rat plasma was developed and validated for the first time. Chromatographic conditions