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Research Article

Quantitative analysis of factor P (Properdin) in monkey serum using immunoaffinity capturing in combination with LC–MS/MS

    Xinliu Gao

    *Author for correspondence:

    E-mail Address: xinliu.gao@novartis.com

    ;

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA

    ,
    Hui Lin

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA

    ,
    Carsten Krantz

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, Basel, Switzerland

    ,
    Arlette Garnier

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, Basel, Switzerland

    ,
    Jimmy Flarakos

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA

    ,
    Francis LS Tse

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA

    &
    Wenkui Li

    **Author for correspondence:

    E-mail Address: wenkui.li@novartis.com

    Department of Drug Metabolism & Pharmacokinetics, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA

    Published Online:https://doi.org/10.4155/bio.15.258

    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.

    Papers of special note have been highlighted as: • of interest; •• of considerable interest

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