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.

Project status

97% Completed

Industry Need

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

Solution

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

Outputs/Deliverables

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

Impacts

Waste of product and downtime due to contamination is reduced.

Publications

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

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