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.
Browsing: Journal Articles
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.
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.
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.
Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis
In this research article, the authors investigate the differences between two methods for matrix-based stability testing. This article is from the special focus issue published by Bioanalysis on Stability Issues in Bioanalysis.
White Paper – EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays
In this White Paper from Bioanalysis, the authors discuss the European Bioanalysis Forum’s recommendations for critical reagents (CR) for immunogenicity assays. They present the requirements for CR and describe the consequences of introducing new lots of CR to immunogenicity assays.
Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS
In this perspective article from Bioanalysis, the authors discuss the similarities and differences of critical reagents in LBAs and hybrid LC–MS assays. The authors propose that the benefits of well-characterized hybrid LC–MS assay reagents are frequently underestimated.
Validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling
In this methodology article from Bioanalysis, authors outline the validation of methods for determining pediatric midazolam using wet whole blood and volumetric absorptive microsampling.
White Paper – incurred sample reproducibility: 10 years of experience and recommendations from the EBF
In this white paper from Bioanalysis the European Bioanalysis Forum reflect on the implementation and use of incurred sample reanalysis as an integrated part of regulated bioanalysis over the last 10 years.