Aim: Novel urinary biomarker evaluation approaches to support inhibition assessment for renal transporters (e.g., OCT2, multidrug and toxin extrusion proteins [MATEs]). Methods: Highly sensitive and robust hydrophilic interaction chromatography–MS/high-resolution MS assays, for urine and plasma, were developed and characterized to evaluate transporter biomarkers including N1-methyladenosine and N1-methylnicotinamide. Results: The assays were simple and reliable with […]
Relative quantification techniques have dominated the field of proteomics. However, biomarker discovery, mathematical model development and studies on transporter-mediated drug disposition still need absolute quantification of proteins. The quality of data of trace-level protein quantification is solely dependent on the specific selection of surrogate peptides. Selection of surrogate peptides has a major impact on the
Background: Crovalimab is a humanized monoclonal antibody targeting human complement C5. Patients switching from eculizumab to crovalimab are expected to form drug-target-drug complexes (DTDCs), since these antibodies each bind to a different epitope on complement C5. An analytical method to evaluate the size distribution of these DTDCs was developed and validated. Methods: Human serum samples
Aim: Assessment of pre-existing anti-drug antibody (preADA) reactivity at early drug development stages can be beneficial for candidate selection. We investigated the applicability of a generic immune-complex anti-drug antibody (ADA) assay for early preADA assessment as an easily available alternative to the commonly used ADA bridging assay. Results: The results confirmed the expected assay difference
Since 2011, the European Bioanalysis Forum has been discussing the topic of context-of-use for biomarker assays, in support of a cross-industry implementation of its principles. The discussions have led to the acknowledgement of the challenges that we face as an industry in implementing these principles. In addition to scientific recommendations, the European Bioanalysis Forum has
Green bioanalytical techniques aim to reduce or eliminate the hazardous waste produced by bioanalytical technologies. A well-organized and practical approach towards bioanalytical method development has an enormous contribution to the green analysis. The selection of the appropriate sample extraction process, organic mobile phase components and separation technique makes the bioanalytical method green. UHPLC-MS is the
High-quality critical reagents are essential for the establishment of robust ligand binding assays to support regulated bioanalysis. To ensure consistency in assay performance over the lifetime of a project, a well-defined set of processes is needed for critical reagent life cycle management. Moreover, contract research organizations must support reagent life cycle management for diverse global
Introduction The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held virtually between 27 September and 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
Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of qPCR and a complete lack of any regulatory guidelines for the use of
Anahita Keyhani speaks to Sankeetha Nadarajah, Commissioning Editor Biography Dr Anahita Keyhani joined Altasciences in May 2015 and has over 20 years of contract research organization (CRO) experience in regulated bioanalysis for preclinical and clinical development. As Senior Director of Scientific Operations, Mass Spectrometry, Dr Keyhani leads a team of over 40 scientists dedicated to