Large Molecule Quantification by Hybrid LBA/LCMS in a Regulated environment: Our Validation SOP

 
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eBulletin   |   December 2014  
REDEFINING QUALITY - Full Service Provider Focused on Early Stage Clinical Research
 
Large Molecule Quantification by Hybrid LBA/LCMS in a Regulated environment: Our Validation SOP
 

The use of LCMS detection for the bioanalysis of Large Molecules (LM) offers many advantages, including high specificity, wide linear dynamic range, fast method development, and the ability to quantify multiple proteins simultaneously. To fully support the bioanalysis of LM involving hybrid LBA/LCMS, Algorithme Pharma has developed an SOP in line with current industry standards.

REDEFINING QUALITY - Full Service Provider Focused on Early Stage Clinical ResearchGiven the potential increase in variability associated with the complexity of LM bioanalytical assays involving highly selective affinity capture enrichment, either prior to, and/or after enzymatic digestion (i.e. hybrid LBA/LCMS approaches), such LM assays require unique validation and sample analysis considerations. Noticeably, they involve the application of acceptance criteria wider than that of small molecules. Algorithme Pharma's SOP outlines the specifics of the validation process of such LM bioanalytical assays in a regulated environment. The main difference between the bioanalysis of small molecules by LCMS and large molecules by hybrid LBA/LCMS is the general acceptance criteria being applied:

 
 

% deviation from nominal concentration widened to ±20.0% (±25.0% for the LOQ) instead of ±15.0% (±20.0% for the LOQ);

 

precision (%C.V.) and accuracy (%Nominal) for all matrix-based evaluations extended respectively to ≤ 20.0% (≤ 25.0% at the LOQ) and 80.0%-120.0% (75.0%-125.0% at the LOQ);

 

% difference for samples re-assayed as ISR widened to ≤ 30.0% instead
of ≤ 20.0%.

 

The team at Algorithme Pharma provides full bioanalytical support for LM through all phases of clinical development, including as part of regulated studies. The most recent work on the bioanalysis of large molecules by LCMS will be presented at the following events, in 2015:

 
 

Nordics Peptide Bioanalysis Symposium — Copenhagen, February

 

6th Japan Bioanalysis Forum (JBF)Tokyo, February

 

9th Workshop on Recent Issues in Bioanalysis (WRIB)Miami, April

 

AAPS NBCSan Francisco, June

 
To learn more about these or past presentations >>
 
 
 
 
For more information, please contact us:
 
450 973-6077 | 888 267-7449 | contact@algopharm.com
 
 
 
 
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