In this interview, we talk to Mary Lame (Principal Applications Scientist, Waters Corporation; MA, USA) who discusses the key challenges scientists face when developing robust peptide bioanalytical assays.
Browsing: Expert opinion
In this interview, John Kadavil (US FDA; MA, USA) shares his thoughts on the draft ICH M10 guidance for bioanalytical method validation, indicating how this will change the bioanalytical regulatory landscape.
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).
Find out more about what is important when outsourcing, in this interview with Lee Abberley (GSK).
“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 Yu Shrike Zhang (Harvard Medical School; MA, USA), a previous finalist of the Bioanalysis Rising Star Award, discusses his research and hopes for the future. He details the emergence of organ-on-a-chip systems and how these platforms reproduce tissue functions outside the human body.
Considerations for developing and validating an LC–MS biomarker assay using the surrogate peptide approach
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).
Developing bioanalytical LC–MS/MS methods for biotherapeutics and biomarkers: an interview with William Mylott
In this expert interview, William Mylott discusses developing bioanalytical LC–MS/MS methods for biotherapeutics and biomarkers.