Figure 1 - uploaded by Nadine Ritter
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example flow chart of cell banking process
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Context 1
... assay development is an ongoing process divided into separate stages. This section is not meant to be a guide to bioassay development or validation -other references focus on the subject (1, 3, 4, 11). Instead we highlight the role of cell banks in development of bioassays or production of critical reagents. ...
Context 2
... banking should be initiated once initial characterization and feasibility testing are complete. Figure 1 outlines a recommended flow pattern for preparing most MCBs and WCBs. Additional method development using cells other than those from working cell banks should be approached with caution. ...
Context 3
... dilution (titer) is documented and typically used throughout the lifetime of a particular set of aliquots in a given bank, assuming that the bank is confirmed to be stable in long-term storage. The long-term stability of bacterial cell banks must be evaluated for each strain with the specific cryopreservation medium used (12, 13). At predetermined intervals, remove a vial from the bank, then revive the cells and retest them for viability, percent recovery, purity, and function in your bioassay to confirm that the critical properties of the bank remain constant. ...
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The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples. This comprehensive article first describes evolving technologies and assay formats that encourage scientists to start development with appropriate analytical goals that are specific to their clinical program. The selection of the technology and format is based primarily on the product's structure, treatment indication, intended treatment schedule and pharmacokinetic profile. Feasibility studies are described to satisfy specific criteria before proceeding to optimization. Preparation procedures and storage conditions of critical reagents and controls are provided that will render them suitable throughout the length of the project. A multifactor approach to robustness is recommended that assures consistently sensitive, accurate, precise and specific methods that are verified during prevalidation experiments. Finally, a checklist itemizes all the requirements to develop a compliant validation protocol.
