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Model-Based Risk Assessment of mAb Developability

In: Optimization of Pharmaceutical Processes

Author

Listed:
  • M. Karlberg

    (Newcastle University)

  • A. Kizhedath

    (Newcastle University)

  • J. Glassey

    (Newcastle University)

Abstract

Monoclonal antibodies were already one of the fastest growing sectors of biopharmaceutical industry [1]. Recent research on the significant benefits of various antibodies in reducing the risks of fatality or reducing the symptoms of COVID-19, e.g., tocilizumab and sarilumab (Cortegiani et al. 2021), inevitably increases the importance of the rapid discovery of mAbs and the development of efficient manufacturing processes. Research reports frequently concentrated on the rapid discovery of new mAbs, but the developability and the manufacturability of mAbs were less explored until recently [1–4]. This chapter adopts the framework of quality by design (QbD), concentrating particularly on the model-based risk assessment of mAb developability. A case study highlights specific areas where advanced modelling approaches can contribute to speeding up the manufacturability and developability of mAbs and demonstrates the benefits and the challenges of this approach.

Suggested Citation

  • M. Karlberg & A. Kizhedath & J. Glassey, 2022. "Model-Based Risk Assessment of mAb Developability," Springer Optimization and Its Applications, in: Antonios Fytopoulos & Rohit Ramachandran & Panos M. Pardalos (ed.), Optimization of Pharmaceutical Processes, pages 373-391, Springer.
    • Handle: RePEc:spr:spochp:978-3-030-90924-6_14
    DOI: 10.1007/978-3-030-90924-6_14
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