PI – Rapid Micro: novel methods and control strategy

Integrated continuous bioprocessing (ICB) can strain conventional process analytics. A two-tiered approach of rapid microbial technology and the corresponding control strategy is imperative to mitigate the risk of bioburden as the industry shifts to ICB.

Industry Need

Delayed contamination detection wastes material and capacity. This is made worse in integrated/continuous processing.

Approach

Identification of rapid methods (results in 8 hours or less) and integration of those methods into quality systems.

Impacts

Waste of product and downtime due to contamination is reduced.

Reduction of time to results from 5 days to 8 hours or less

Saves 4 days plant capacity after each contamination

Value Statement/Outcomes

By implementing the rapid microbial testing with a two-tiered control strategy identified in this project, an organization could reduce the risk of wasted raw materials and plant time due to undetected contamination by up to 80%, enabling real-time process monitoring and faster decision-making for continuous bioprocessing.

Outputs/Deliverables

The primary deliverable of this project will be a peer-reviewed publication that explores rapid micro technologies and their potential to enhance efficiency, scalability, and innovation within the biopharmaceutical industry.

Grampp, G., Bosley, A., Qadan, M., Schiel, J., Spasoff, A., Valax, P., Schaefer, G. Managing integrated continuous bioprocesses in real time: Deviations in product quality. Biotechnology Progress, published November 28, 2023. https://doi.org/10.1002/btpr.3414

Publications

Ramos, I., Najera, M., Schaefer, G. Integration of Rapid Bioburden Testing into Production Quality Management Systems and Process Control. Biotechnology Progress, published March 7, 2024. https://doi.org/10.1002/btpr.3431