Microbial Cell Banks as Active Assets: A Risk-Based Functional Qualification скачать в хорошем качестве

Microbial Cell Banks as Active Assets: A Risk-Based Functional Qualification

This Episode outlines a Quality by Design framework for managing microbial cell banks as active, biological assets rather than static storage items. It emphasizes using a risk-based approach to monitor how factors like cell age, freezing methods, and storage stability impact long-term manufacturing performance. By applying statistical process control and evaluating post-thaw recovery kinetics, organizations can identify performance drifts before they compromise production yields. The strategy integrates functional release criteria and rigorous trending to ensure that starting materials remain consistent throughout their entire lifecycle. Ultimately, these protocols allow for defensible decision-making regarding bank replacement and proactive mitigation of potential failures. This systematic oversight transforms cell banking into a foundational element of process capability and regulatory compliance. #Bioprocess #ScaleUp and #TechTransfer, #Industrial #Microbiology, #MetabolicEngineering and #SystemsBiology, #Bioprocessing, #MicrobialFermentation, #Bio-manufacturing, #Industrial #Biotechnology, #Fermentation Engineering, #ProcessDevelopment, #Microbiology, #Biochemistry #Biochemical Engineering, #Applied #MicrobialPhysiology, #Microbial #ProcessEngineering, #Upstream #BioprocessDevelopment, #Downstream Processing and #Purification, #CellCulture and #MicrobialSystems Engineering, #Bioreaction #Enzymes #Biocatalyst _________________________________________________________ Timestamp Timestamp Problem Addressed 03:01 – 04:03 Unquantified Genetic & Phenotypic Drift 04:10 – 05:02 Break in Traceability & Genetic Integrity 05:07 – 05:59 Inconsistent Inoculation & Fermentation Timing 07:45 – 08:32 Predicting Large-Scale Performance at Release 08:38 – 10:02 Subjective Decision Making in Quality Release 10:35 – 11:58 Undetected Chronic Bank Degradation