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.
Categories
Proteins/ Antibodies
Project status
98% 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, published March 7, 2024. 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
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