The November issue manufacturing theme features articles on biopharmaceutical manufacturing data analysis and visualization, ADC development, antibody higher order structure stability, microchip chromatography, and using minibioreactors for microbial cultivation scale-down.
FEATURED REPORT: Bioprocess Monitoring and Control
The need for advanced control strategies for bioprocessing and biomanufacturing is growing, and several manufacturers already have leveraged new automation and software solutions for bioprocess monitoring and control. In this Featured Report, authors discuss new approaches for process control that make use of increased computational power; advanced sensors, probes, and sampling technologies; and new software systems that can be applied to a wide range of operational modes (e.g., perfusion, continuous, and multicolumn platforms). Such technologies can be applied with single-use systems and within PAT and “machine learning” applications.
The Chinese hamster ovary (CHO) cell line is the most prevalent biopharmaceutical expression system and has been proven safe for commercial production of protein therapeutics (1). However, even after multiple purification steps, biopharmaceuticals contain residual host-cell protein (HCP) impurities that pose a potential safety risk to patients (2). Health authorities demand close monitoring of HCP impurities and require sensitive analytical methods with high coverage: the ability to detect a broad range of HCP impurities (3, 4). Polyclonal sandwich immunoassays are…