In this Bioanalysis Zone interview, Pegah Jalili (MilliporeSigma) discusses her current work in analytical R&D of biotherapeutic characterization and quantification, and what she thinks the future looks like for this field of bioanalysis.
In this Editorial from Bioanalysis, the authors consider the future for hybrid assays following the US FDA recently issued guidance for hybrid assays. Find out more and access the full article, exclusively for Bioanalysis Zone members.
Find out more about the evolution of fit-for-purpose biomarker validations from an LBA perspective in this free article from Bioanalysis.
3-(4-Hydroxyphenyl)propionic acid: the forgotten detection substrate for ligand-binding assay-based bioanalysis
In this review article the authors outline the increase in sensitivity and dynamic range when using fluorogenic 3-(4-hydroxyphenyl)propionic acid in preference of other conventional colorimetric ELISA, LBA technologies and LC-MS assays.
Validation of a ligand-binding assay for active protein drug quantification following the ‘free analyte QC concept’
In this research article the authors describe the validation of a ligand-binding assay for active protein drug quantification and address practical challenges as well as regulatory implications.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)
This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during this years 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) which took place in Orlando, Florida earlier this year. The report is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LC–MS
In this commentary, the author aims to provide some clarity on accuracy-related expectations for the regulated bioanalysis of ‘endogenous’ analytes.
Considerations for Ligand Binding Assay Platforms: how to choose the right platform to meet your drug development needs
Bioanalytical assays are essential in drug development. In recent years, many new technologies have emerged which offer scientists throughput, sensitivity, multiplexing, and the ability to better understand the data.
In this publication Imperacer® case studies demonstrate the advantage of broad assay range combined with excellent sensitivity for several Biologics on their way from R&D to clinics.
Imperacer (Immuno-PCR) method for ultra sensitive quantification of Interleukin-6 to support clinical Phase III trial (Chimera Biotec)
Exponential signal amplification on the Imperacer platform allows reduction of sample volume to a few microliter, still maintaining single digit pg/ml sensitivity for study support wherever sample volume is critical.