Inline Spiking Method for Validation of Virus Clearance in Continuous Bioprocessing

Performance Period: 8/15/2020 to 12/31/2021

The overall objective of this project is to develop an inline spiking protocol suitable for use in the evaluation and validation of virus clearance in connected / continuous bioprocessing. This will involve the use of a small injection / sampling pump that can directly inject a virus spike and a non-interacting tracer into the process stream at specific locations within the purification process, with samples collected at appropriate locations downstream of the injection. The tracer data will allow the user to quantitatively map the residence time distribution across individual or linked unit operations using computational tools developed as part of this project. These data will be combined with virus concentration measurements to evaluate the viral clearance for continuous / connected unit operations without disruption of the overall downstream process. The development of an effective strategy for evaluation and validation of the virus clearance capabilities for continuous / connected processes is essential for the successful implementation of these processes in commercial biomanufacturing.