All about cell therapy process characterization
Abstract: Process characterization is essential for cell therapy programs, ensuring consistent, safe, and effective products that meet regulatory standards. The article describes the three stages of process characterization—design, qualification, and life cycle management—highlighting the importance of robust analytical methods, risk assessment, process control, and data management. It addresses common bottlenecks and emphasizes the role of CDMOs in providing advanced tools, regulatory guidance, and strategic support to help developers achieve validated, scalable processes and accelerate time to market.