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Peptides and Oligonucleotide-Based Therapy: Bioanalytical Challenges and Practical Solutions

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An Introduction to Bioanalysis of Biopharmaceuticals

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 57))

Abstract

Peptide and Oligonucleotide (ON) are gaining popularity with multiple regulatory approvals in recent years. Most of the approvals are in genetic disorders for various disease areas. Peptides and ON molecules are considered as small-molecule drugs that are synthesized with various chemical and structural modifications to improve their physicochemical and biological properties, such as efficacy, stability, bioavailability, safety, etc. These modifications require thorough understanding of these molecules and exclusive strategies to quantify these molecules in various biological matrices. This chapter provides an overview of currently available methodologies and strategies employed for bioanalytical and immunogenicity assessment of  peptides and ON therapeutic modalities.

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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 (Thermo Fisher Scientific for Morse Faria, Spark therapeutics for Inderpal Singh, and Wave Life Sciences for Ramakrishna Boyanapalli).

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Authors and Affiliations

  1. Bioanalytical and biomarker Development, Wave Life Sciences, Cambridge, MA, USA

    Ramakrishna Boyanapalli

  2. Spark Therapeutics, Philadelphia, PA, USA

    Inderpal Singh

  3. Clinical Research Group, Thermo Fisher Scientific, Richmond, VA, USA

    Morse Faria

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  1. Ramakrishna Boyanapalli
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  2. Inderpal Singh
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  3. Morse Faria
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  1. Drug Disposition and Design/DDT, Biopharma R&D, EMD Sereno Research and Development Institute, Billerica, MA, USA

    Seema Kumar

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Boyanapalli, R., Singh, I., Faria, M. (2022). Peptides and Oligonucleotide-Based Therapy: Bioanalytical Challenges and Practical Solutions. 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_6

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