Abstract
The bioanalysis of biopharmaceuticals is central to the drug development process. The efficacious dose projections of biopharmaceuticals rely on a robust, sensitive, specific, and selective bioanalytical assays that accurately quantitate the analyte(s) of interest. The bioanalysis of large-molecule biotherapeutics is more complex than their lower molecular weight counterparts. The immunogenicity of large-molecule biotherapeutics brings another level of complexity to their bioanalysis. The advent of new biotherapeutic modalities such as bispecifics, multi-specifics, fusion proteins, antibody-drug conjugates, oligonucleotides, gene and cell therapy drugs that span beyond the realms of large-molecule and small-molecule therapeutic modalities has made the bioanalytical landscape more complex. Traditionally, ligand binding assays (LBA) and liquid chromatography coupled with mass spectrometry (LC-MS) have been the work horse for large-molecule and small-molecule therapeutics, respectively. However, the expansion of therapeutic modalities beyond the conventional realms of large-molecule and small-molecule therapeutics has led to the increased utility of combination of LBA and LC-MS approaches for the bioanalysis of these complex therapeutics. The challenges of gene therapy and cell therapy bioanalysis are attributed to their unique delivery systems, technologies, and the complex nature of immune responses against these multi-component therapeutics.
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Any opinions or forward-looking statements expressed are those of the authors and may not reflect views held by their employers (Janssen Therapeutics for Sanjeev Bhardwaj, Spark Therapeutics for Inderpal Singh, and Virginia Commonwealth University for Matt Halquist).
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Bhardwaj, S., Singh, I., Halquist, M. (2022). Introduction. In: Kumar, S. (eds) An Introduction to Bioanalysis of Biopharmaceuticals. AAPS Advances in the Pharmaceutical Sciences Series, vol 57. Springer, Cham. https://doi.org/10.1007/978-3-030-97193-9_1
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