🧪 This model operates without a surge vessel. It demonstrated complete removal of porcine parvovirus in a 72-hour test.
✨ It promises to improve operational efficiency and reduce processing times in biomanufacturing. Future optimization is needed for widespread implementation.
Introduction:
This article discusses advancements in validating viral clearance in continuous bioprocessing through a novel small-scale virus filtration model developed by researchers at Asahi Kasei Bioprocess America. This innovation aims to enhance efficiency and operational flexibility while ensuring effective viral clearance in bioprocess systems.
- The model allows for validation of connected continuous chromatography and virus filtration systems without the need for a surge vessel.
- It achieved complete removal of a porcine parvovirus (PPV) with a logarithmic reduction value (LRV) exceeding 5.5, demonstrating its effectiveness in continuous viral clearance.
- The continuous process operates in a constant flow environment, successfully processing both bovine serum albumin (BSA) and monoclonal antibody (mAb) solutions over 72 hours without disruption.
- Engineers typically face challenges in adapting traditional virus filtration validation methods, which are primarily designed for batch processes, to meet the demands of continuous processing.
- Future developments will require optimization of connected virus filtration systems and the design of new skid configurations to accommodate uninterrupted continuous feed.
Conclusion:
The development of this virus filtration validation model represents a significant step toward fully continuous bioprocessing, with promising implications for operational efficiency and cost savings. The ability to replicate this model in other R&D facilities may lead to enhanced methodologies in viral clearance, although further optimization and system design will be necessary to address existing limitations.
