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Microbial Cell Bank Lifecycle and Quality Control Architecture

This episode details a Quality by Design (QbD) framework for managing microbial cell banks throughout their entire manufacturing lifecycle. It emphasizes that cell banking should be treated as a controlled unit operation rather than simple freezer storage, utilizing specific quantitative metrics like cumulative population doublings to define cell age. The sources outline a hierarchical architecture consisting of Master Cell Banks, Working Cell Banks, and End-of-Production banks to ensure genetic stability and operational consistency. Furthermore, the material explores how organism-specific cryopreservation and rigorous stability trending protect the critical quality attributes of various microbial strains. By integrating regulatory expectations with functional risk assessments, the text establishes a comprehensive blueprint for maintaining phenotypic integrity and production reliability. Overall, the documentation serves as a strategic guide for transforming cell banking into a sophisticated platform discipline for industrial biotechnology. __________________________________________________ Timestamp Timestamp Problem Addressed 03:22 – 04:08 Determining the "End of Life" for a Production Strain 04:16 – 04:52 Genetic Drift and Loss of Baseline Integrity 05:24 – 06:59 Predicting Batch Performance via Cellular History 07:05 – 08:01 Preserving Product Quality in Inducible Systems 08:08 – 09:16 Membrane Rupture and Periplasmic Leakage 09:56 – 10:28 False Positives in Cell Bank Release Testing 11:26 – 12:25 Defining Tolerance for Power Failures 13:02 – 13:53 Unpredicted Product Degradation