This chapter, titled Process Development for Biologics Therapeutics, provides a comprehensive overview of the advancements and critical elements in the development of biologics production processes. It explores the evolution of process development, highlighting key innovations in cell line development, upstream and downstream processing, and drug product formulation. The chapter delves into the importance of a comprehensive set of analytical methods and process characterization studies to ensure the quality, safety, and efficacy of biologics. It also examines the regulatory framework outlined in ICH guidelines and the Quality by Design (QbD) approach, which guides the systematic design and development of robust and reliable processes. The discussion includes considerations for technology transfer, scale-up challenges, and the role of data science in optimizing process parameters and improving yields. Furthermore, the chapter addresses process intensification strategies, which aim to enhance production efficiency and sustainability. By bridging scientific principles with industrial practices, this comprehensive overview aims to provide a thorough understanding of the various facets of biologics process development, from early-stage research to large-scale manufacturing.

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Process Development for Biologics Therapeutics

  • Ankur Bhatnagar,
  • Partha Hazra,
  • Harish V. Pai,
  • Navratna Vajpai,
  • Karthik Ramani,
  • Nagaraj Govindappa

摘要

This chapter, titled Process Development for Biologics Therapeutics, provides a comprehensive overview of the advancements and critical elements in the development of biologics production processes. It explores the evolution of process development, highlighting key innovations in cell line development, upstream and downstream processing, and drug product formulation. The chapter delves into the importance of a comprehensive set of analytical methods and process characterization studies to ensure the quality, safety, and efficacy of biologics. It also examines the regulatory framework outlined in ICH guidelines and the Quality by Design (QbD) approach, which guides the systematic design and development of robust and reliable processes. The discussion includes considerations for technology transfer, scale-up challenges, and the role of data science in optimizing process parameters and improving yields. Furthermore, the chapter addresses process intensification strategies, which aim to enhance production efficiency and sustainability. By bridging scientific principles with industrial practices, this comprehensive overview aims to provide a thorough understanding of the various facets of biologics process development, from early-stage research to large-scale manufacturing.