Biodefense and pandemic response
Mechanisms for establishing a rapid response to biological threats either through nefarious activities or pandemics have been of personal interest for many years due to the technical challenges involved in mounting an effective response
The use of readily available single use systems for biomass generation (microbial fermentation or cell culture), process stream (buffers, feeds, fraction collection) and membrane technologies coupled with modular GMP ready facilities offer a new approach to process portability.
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Improvements in recombinant protein expression (mode, titer, productivity) can greatly reduce the volumetric requirements/limitations for vaccine manufacturing processes.
Back in 2006 I was concerned about portability and the reliance on stainless steel STR (stirred tank reactors) for microbial based vaccine manufacture and available GMP capacity within the US. The concept of portability with respect to process design, physical assets and the ability to rapidly establish regional overflow manufacturing (reduce supply chain risk) are still valid in the 2020s.
Single use bioreactors (SUBs) are well established for mammalian cell culture however microbial fermentation presented greater engineering challenges with respect to mixing (drive coupling, bulk mixing, mass transfer, power input), cooling efficiency, exhaust configuration and sensor technology. Fortunately the latest generation of single use fermenters (SUFs) have made major strides in solving these issues. High cell density fed-fermentation necessary for process portability (5-10 fold volume reduction) is essential. A direct comparison of a traditional stainless steel STR with a single use fermentation system using Escherichia coli as the test organism is presented by Sartorius (https://www.sartorius.com/en) - see resource listing below. Other vendors such as Thermofisher, GE Lifesciences offer single use fermentation systems (see resource listing below) GE lifesciences has produced a white paper comparing the merits of single use systems compared to traditional assets.