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Bioanalytical method validation considerations for LC-MS/MS assays of therapeutic proteins
- Source :
- Bioanalysis. 7(11)
- Publication Year :
- 2015
-
Abstract
- This paper highlights the recommendations of a group of industry scientists in validating regulated bioanalytical LC–MS/MS methods for protein therapeutics in a 2015 AAPSJ White Paper. This group recommends that most of the same precision and accuracy validation criteria used for ligand-binding assays (LBAs) be applied to LC–MS/MS-based assays where proteins are quantified using the LC–MS/MS signal from a surrogate peptide after proteolytic digestion (PrD-LCMS methods). PrD-LCMS methods are generally more complex than small molecule LC–MS/MS assays and may often include LBA procedures, leading to the recommendation for a combination of chromatographic and LBA validation strategies and appropriate acceptance criteria. Several key aspects of this bioanalytical approach that are discussed in the White Paper are treated here in additional detail. These topics include selectivity/specificity, matrix effect, digestion efficiency, stability and critical reagent considerations.
- Subjects :
- Bioanalysis
Protein therapeutics
Chemistry
Protein Stability
Clinical Biochemistry
Proteolytic enzymes
Chromatography liquid
Proteins
General Medicine
Validation Studies as Topic
Computational biology
Tandem mass spectrometry
Bioinformatics
Analytical Chemistry
Medical Laboratory Technology
Protein stability
Tandem Mass Spectrometry
Lc ms ms
Humans
Indicators and Reagents
General Pharmacology, Toxicology and Pharmaceutics
Chromatography, Liquid
Subjects
Details
- ISSN :
- 17576199
- Volume :
- 7
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Bioanalysis
- Accession number :
- edsair.doi.dedup.....33a89303c5e34a2a1ef773c2943f3444