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Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review

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Abstract

Abstract. The development of monoclonal antibody (mAb) biosimilars is a complex process. The key to their successful development and commercialization is an in-depth understanding of the key product attributes that impact safety and efficacy and the strategies to control them. Functional assessment of mAb is a crucial part of the comparability of biopharmaceutical drugs. The development of a relevant and robust functional assay requires an interdisciplinary approach and sufficient flexibility to balance regulatory concerns as well as dynamics and variability during the manufacturing process. Although many advanced tools are available to study and compare the potency and bioactivity of the protein, most of these techniques suffer from major shortcomings that limit their routine use. These include the complexity of the task, establishment of the relevance of the chosen method with the mechanism of action (MOA) of the biosimilar, cost and extended time of analysis, and often the ambiguity in interpretation of the resulting data. To overcome or to address these challenges, the use of multiple orthogonal state-of-the-art techniques is a necessary prerequisite.

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Acknowledgements

This work was funded by the Centre of Excellence for Biopharmaceutical Technology grant from the Department of Biotechnology, Ministry of Science and Technology (BT/COE/34/SP15097/2015). RD acknowledges the Indian Council of Medical Research (5/3/8/56/ITR-F/2018-ITR), New Delhi, India, for her fellowship.

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Authors and Affiliations

  1. Department of Chemical Engineering, DBT Center of Excellence for Biopharmaceutical Technology, Indian Institute of Technology Delhi, Hauz Khas, New Delhi, 110016, India

    Rozaleen Dash, Sumit Kumar Singh & Anurag S. Rathore

  2. School of Biochemical Engineering, IIT-BHU, Varanasi, India

    Sumit Kumar Singh

  3. SymphonyTech Biologics, Pune, India

    Narendra Chirmule

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  1. Rozaleen Dash
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  2. Sumit Kumar Singh
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  3. Narendra Chirmule
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  4. Anurag S. Rathore
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All authors planned the review. RD and SKS wrote the first draft of the paper. NC and ASR supervised the project. ASR was responsible for the funding and reviewed and edited the final paper.

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Correspondence to Anurag S. Rathore.

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Dash, R., Singh, S.K., Chirmule, N. et al. Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review. AAPS J 24, 15 (2022). https://doi.org/10.1208/s12248-021-00671-0

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