Effective therapies and prophylactic vaccines for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is causing the coronavirus disease 2019 (COVID-19) pandemic are urgently needed. The scientific community is rapidly testing antivirals that target the ability of SARS-CoV-2 to infect and replicate including protease inhibitors, polymerase inhibitors and antimalarials
Coronavirus disease 2019 (COVID-19) is an emerging condition threatening the biosecurity of all nations on the planet. This pandemic of respiratory disease, caused by a novel β-coronavirus (called severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]), has high sequence similarity to SARA-CoV, which was responsible for a major outbreak in 2002–2003
Direct ambient ionization techniques have been developed with the aim to reduce the complexity of mass spectrometry analysis by minimizing sample preparation and chromatographic separation. In this context, paper spray-MS (PS-MS) is an innovative approach that provides faster and cheaper analysis of biofluids by the addition of the sample directly to a paper. In forensic
Background: Polyethylene glycolylation (PEGylation) technology is a long-acting delivery platform used to increase the half-life of protein therapeutics. Quantitation of PEGylated anti-Factor D Fab (PEG-aFD) poses bioanalytical challenges. Results: An ELISA was developed to determine total Fab concentration in cynomolgus monkey serum following intravitreal administration of PEG-aFD. However, assay characterization showed a low recovery of
Aim: Our objective was to develop and qualify a bioanalytical method for the estimation of di-18:1-bis(monoacylglycero)phosphate (di-18:1 BMP) as a urinary biomarker for the assessment of drug-induced phospholipidosis and demonstrate its application in a preclinical study. Methodology/results: di-18:1 BMP was extracted by liquid–liquid extraction using n-butanol and analyzed by LC–MS/MS. The qualified method was selective,
Accessing patient samples using a whenever/wherever paradigm is needed to enable a better understanding of human biology and disease. The technology for convenient self-collection of blood samples by patients at home is quickly becoming available. The potential benefits of patient-centric sampling far outweigh the short-term challenges associated with implementation of this disruptive approach. This is
This paper shares experiences and learning from introducing patient-centric sampling (PCS) into AstraZeneca trials. Through two case studies we show how modeling approaches can assist pharmacokinetic (PK) bridging studies accounting for blood partitioning and hematocrit and how reduced PK sampling schedules, profiles constructed from composite data (plasma & dry blood) and combined assays (PK &
Aim: Evaluation of a novel microsampling device for its use in clinical sample collection and biomarker analysis. Methodology: Matching samples were collected from 16 healthy donors (ten females, six males; age 42 ± 20) via K2EDTA touch activated phlebotomy (TAP) device and phlebotomy. The protein profile differences between sampling groups was evaluated using aptamer-based proteomic
In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC–MS/MS bioanalytical method was developed
Aim: A method has been developed and validated for quantitation of selumetinib in human whole blood collected using a Mitra™ volumetric absorptive microsampling device. This device is patient-friendly, affording less-invasive sampling with broad applicability to clinical and diagnostic applications – specifically in pediatric populations. Materials & methods: In this method, drug is extracted from the