Bioburden Control Strategies for Continuous Downstream Processing
Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process.
While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing.
To provide clarification on strategies for bioburden control in continuous downstream processing, Pall’s Britta Manser, Manager, Continuous Bioprocess, Scientific and Laboratory Services Europe, presented a video where she provides specific strategies that can be implemented to minimize bioburden in continuous downstream operations.
Minimizing Bioburden in Continuous Downstream Processing
She begins the presentation by discussing the importance of implementing bioburden control strategies for operation consistency and that since downstream unit operations are typically in process for a longer period of time, they can face a greater risk of biological contamination between unit operations. However, because continuous downstream bioprocessing shortens the residence time of fluid in the unit operations, and also the entire time that the material is held in tanks, the opportunity for bioburden contamination is significantly reduced.
She then discusses that the best way to mitigate risk in continuous downstream bioprocessing is to prevent introduction. She explains the importance of using gamma irradiated single-use assemblies to ensure zero initial bioburden at the start of a campaign. She goes on to describe that continuous bioprocessing is typically more efficient with resources because of the higher specific productivity. This allows a viable single-use format for most downstream process unit operations. Then, these units can be connected aseptically or welded to create a functionally closed system, thereby reducing the risk of bioburden even further.
She states that bioburden control filters can also be used at strategic points in the downstream process to segregate certain parts of the process and avoid potential propagation of contaminants.
Lastly, rapid microbial testing can be considered to test for bioburden at certain points in the process. These testing methods will in the future enable to detect bioburden levels early on in the process thanks to their fast response time.
To see the complete video:
In addition, Pall is hosting a webinar, “The Challenges of Automating a Continuous Downstream Biotechnology Process,” which will examine the steps required to implement a continuous downstream platform and also the main challenges. This webinar will present a case study example highlighting a collaboration between Pall and CPI. Both parties will present, giving both supplier and end user perspectives on the implementation process.