Monitor and Control Upstream Bioprocessing using a Point-of-Need Mass Spectrometer

Abstract

The applications of mass spectrometry in the pharmaceutical industry have long been established. Mass spectrometers are highly versatile and commonly used to identify reagents, products, contaminants, and impurities from samples in drug research and development, scale-up, and high volume manufacturing lines. However, the instruments are normally large, power demanding, and expensive pieces of equipment operated in centralized laboratories by MS specialists. The new demands of bioprocessing, used to make biologics, means that there is a need for analytical instruments, such as mass spectrometers, to provide real-time information (on-line and at-line) at the point-of-need. The information-rich data provided by MS also helps to address the increased complexities of bioprocessing. We show how our deployable, and compact mass spectrometer sampling the media from a bioreactor environment in real-time could provide important process monitoring, and critical quality attributes of the product. This information can then be used to maximize yields of biologics by optimising the cell media, feeding, and harvesting strategies of the target biologic being produced. In addition, MS point-of-need analysis provides timely safety assurance as any harmful PTMs of the product, and other dangerous host cell proteins can be controlled and minimized upstream.