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 Training
This featured report continues BPI’s annual focus on biomaufacturing training by introducing some programs through which industry and academia are extending science to the production floor. After an introduction from NC State University’s Biomanufacturing Training and Education Center, articles from the United Kingdom (University College London) and the Netherlands (the Biotech Training Facility) describe two different approaches. The final article describes a collaborative program driven by a US government initiative that brings together many different perspectives from industry, academia, and beyond.
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…