Journal
BIOANALYSIS
Volume 8, Issue 5, Pages 425-438Publisher
FUTURE SCI LTD
DOI: 10.4155/bio.15.258
Keywords
biomarker; factor P (Properdin); immunoaffinity capturing; LC-MS/MS; serum depletion; stable-isotope-labeled peptide internal standard; surrogate peptide
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Aim: Factor P (Properdin), an endogenous glycoprotein, plays a key role in innate immune defense. Its quantification is important for understanding the pharmacodynamics (PD) of drug candidate(s). Results: In the present work, an immunoaffinity capturing LC-MS/MS method has been developed and validated for the first time for the quantification of factor P in monkey serum with a dynamic range of 125 to 25,000 ng/ml using the calibration standards and QCs prepared in factor P depleted monkey serum. The intra-and inter-run precision was <= 7.2% (CV) and accuracy within +/- 16.8% (% Bias) across all QC levels evaluated. Results of other evaluations (e.g., stability) all met the acceptance criteria. Conclusion: The validated method was robust and implemented in support of a preclinical PK/PD study.
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