All immunogenicity assessments present specific challenges. As a contract research organization (CRO), a major challenge we face is related to the lack of harmonization and standardization. Find out more in this editorial from a team at LGC (Cambridgeshire, UK).
“There are, in essence, two schools of thought that I can perceive when discussions occur on the topic of appropriate purity of the laboratory water and various solvents, additives and reagents for any given stage of a quantitative bioanalytical procedure.” Find out more from Robert MacNeill (Envigo) in this editorial column.
In this editorial, Timothy Sikorski (GSK; PA, USA), discusses particular considerations for developing and validating LC–MS biomarker assays using the surrogate peptide approach.
In this editorial, Robert MacNeill (Envigo) dicusses the case for the surrogate analyte approach for biomarker validation.
Find out more about ensuring the validity of biomarker measurements in this Editorial from Liam Heaney (University of Loughborough, UK).
Read time: 3:45 mins
Find out more about the immunogenicity of antibody–drug conjugates (ADCs) in this column from Corinna Fiorotti, Business Development Director at BioAgilytix (NC, USA).
Read time: 4:30 mins
In this column, Afshin Safavi differentiates between ‘assay qualification’ and ‘assay validation’ explaining current industry guidance, the translation of this guidance into the exploratory biomarker world, and how BioAgilytix (NC, USA) approaches these challenges.
In this installment of Robert MacNeill’s (Envigo) column, Robert discusses how to increase column plate count – the most obvious way!