Search
Close this search box.

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
96% 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.

Additional Project Information (Members Only)

Login to the NIIMBL member portal to access more, including: 

  • Updates
  • Value Proposition
  • Related Publications
  • Deliverables

Not yet a member? Learn more about which level of NIIMBL membership is right for you and your organization.

Project Lead

NIIMBL

NIIMBL

Participating Organizations

AstraZeneca

AstraZeneca

Bristol-Myers Squibb

Bristol-Myers Squibb

CSL Behring, LLC

CSL Behring, LLC

Catalent Pharma Solutions, LLC

Catalent Pharma Solutions, LLC

Cytiva

Cytiva

Eli Lilly and Company

Eli Lilly and Company

Genentech

Genentech

GlaxoSmithKline, LLC

GlaxoSmithKline, LLC

Janssen Research & Development, LLC

Janssen Research & Development, LLC

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

MilliporeSigma/EMD Serono

MilliporeSigma/EMD Serono

Pfizer, Inc.

Pfizer, Inc.

Resilience US

Resilience US

Sanofi

Sanofi

Sartorius Stedim

Sartorius Stedim