Irina Ramos (AstraZeneca), Michelle Najera (Evotec), Gene Schaefer (NIIMBL) (2024)
Biotechnology Progress
The move to integrated continuous bioprocessing (ICB), while providing a means for
process intensification, can put added strain on process analytics when conventional
methods are used. For instance, traditional microbial methods provide minimal value
to ICB processes given that the time required for data to become available is much
longer than a typical full cycle of the manufacturing process. Although rapid microbial
detection has been in discussion for over 30 years, it is still not routinely deployed in
commercial biopharmaceutical manufacturing. One contributing factor is the ability
to integrate this technology into a process control strategy and existing quality sys-
tems. An understanding of the capability of microbial detection technology available
today can be leveraged to implement a control strategy for bioburden monitoring in
real time for process intermediates.
