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Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs

    ,
    Kathryn Rogers

    Worldwide Clinical Trials, Drug Development Solutions, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Edward Wells

    Worldwide Clinical Trials, Drug Development Solutions, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Ronald R Bowsher

    EMD Millipore Corporation, BioPharma Services, St Charles, MO 63304, USA, and B2S Consulting, Indianapolis, IN 46237, USA

    ,
    Chad Ray

    Pfizer Global Research & Development, Department of Pharmacokinetics, Dynamics, & Metabolism, San Diego, CA 92121, USA

    &
    Steve Unger

    Worldwide Clinical Trials, Drug Development Solutions, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    Published Online:https://doi.org/10.4155/bio.11.2

    Regulatory recommendations for providing bioanalytical support for biological therapeutics have co-evolved with the increasing success of these unique pharmaceuticals. Immunoassays have been used to quantify biological macromolecules for more than 50 years. These assays rely on the use of antigen-specific antibodies. More recently, LC–MS methods have being adapted to quantitate biologics. LC–MS has attributes that complement the limitations encountered by immunoassays. Whether employing immunoassay or LC–MS methods, compared with traditional chemical-based therapeutics, biological therapeutics present unique analytical challenges to analysts. In this article, we review bioanalytical strategies for supporting biologics and discuss the regulatory and analytical challenges that must be met.

    Papers of special note have been highlighted as: ▪ of interest

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