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

100% 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

Impacts

Waste of product and downtime due to contamination is reduced.

Additional Project Information (Members Only)

Updates
Value Proposition
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Project Lead

NIIMBL

Participating Organizations

AstraZeneca

Bristol-Myers Squibb

CSL Behring, LLC

Catalent Pharma Solutions, LLC

Cytiva

Eli Lilly and Company

Genentech, Inc.

GlaxoSmithKline, LLC

Janssen Research & Development, LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

Pfizer, Inc.

Resilience US

Sanofi

Sartorius Stedim

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