In this Research Article, published by Bioanalysis, investigators from Case Western Reserve University (OH, USA) investigate whether different preanalytical blood processing techniques influence results of digital enzyme-linked immunosorbent assay (ELISA)-based assays for blood biomarkers.
In this feature, we peek behind the paper with Jing Yu and Amanda Hays (PRA Health Sciences, KS, USA) to gain insights into the key challenges of post sample collection whole blood stability. They explain the advantages of the lyse freeze method and how their approach, which has been demonstrated on Tregs, could be implemented in clinical trials that monitor other cellular markers.
In this research article, published by Bioanalysis, investigators from Biogen (MA, USA) and Stat4ward LLC (PA, USA) describe their re-evaluation, in singlet, of data from five pharmacokinetic assay validations and five clinical and preclinical studies, originally run in duplicate. The results of the study confirm that well-developed ligand-binding assays (LBAs) produce comparable data whether evaluated in singlet or duplicate.
Approaches to improve drug tolerance and target tolerance in the assessment of neutralizing anti-drug antibodies
In this research article, published by Bioanalysis, investigators from Janssen Research & Development LLC and Thomas Jefferson University (both PA, USA) describe potential approaches for enabling the development of reliable neutralizing anti-drug antibody (NAb) assays that overcome drug and drug target interference for more precise and sensitive NAb assessment.
At a time where the world is looking to repurposed drugs to give the quickest treatment option to the COVID-19 pandemic, we interview David Fajgenbaum (University of Pennsylvania (PA, USA) and bestselling author of ‘Chasing My Cure’) on what type of treatment he considers to hold the most promise.
In this perspective article, published by Bioanalysis, the authors present the current regulatory recommendations for bioanalytical support of adeno-associated virus-based gene therapy development.
Gene therapy is an experimental technique that involves the delivery of therapeutic nucleic acid polymers into a patient’s cells to treat or prevent a disease.
Jisun HJ Lee and Jiangjiang Zhu discuss volatile organic compounds produced by the gut microbiome and their relationship with human health. They also examine volatilomics, a field of metabolomics dedicated to the detection and quantification of gut microbial volatile compounds to reveal their function in human health and metabolism.
In this feature, we interview key figures about their experiences on the impact of COVID-19 on their businesses and key lessons learnt during the pandemic.
Ensuring biological sample integrity from collection to analysis for LC–MS workflows: case studies illustrating challenges in clinical trials
In this special report, Melanie Anderson (Merck and Co., Inc.; PA, USA) presents several case studies to demonstrate the logistical challenges associated with unstable compounds and unique matrices for LC–MS/MS workflows.