A Promenade into monoclonal antibody production processes. In advanced bioprocess industry

      Аннотация: This book delves into the evolving landscape of monoclonal antibody (mAb) bioprocessing, highlighting advancements crucial for therapeutic applications. It covers the latest technologies in upstream and downstream processing, emphasizing bioreactor systems, cell culture techniques, and purification strategies. Process intensification for increased productivity and cost reduction is a focal point. The study thoroughly addresses critical quality attributes (CQAs) of mAbs, emphasizing the role of process control in maintaining consistent product quality. Safety and efficacy are discussed through analytical methods and quality control procedures. The impact of automation, digitalization, and single-use technologies on scalability and adaptability is analyzed, offering a modern perspective on manufacturing systems. Navigating regulatory considerations and compliance requirements, the book is a comprehensive resource for biopharmaceutical professionals in mAb development. Synthesizing research and industry practices, it highlights the transformative potential of advanced bioprocessing technologies to meet the global demand for high-quality mAb therapeutics.

Ключевые слова: monoclonal antibodies, Bioproduction, Upstream processing, downstream processing, Bioreactor systems, PROCESS INTENSIFICATION, Critical quality attributes (CQAs), Automation, Regulatory considerations, High-quality mAb therapeutics