PM, Flaskworks is what most industries would call a turnkey system, meaning it is used as made. However since it has not been used by other companies to mfg other drugs all Flaskworks system development has to be qualified first. When equipment is used by multiple mfgrs in pharma the equipment performs most basic qualification work and it becomes a given by RA's. That must be done for Flaskworks no matter how simple of a device it is and the key is in the software qualification. After that it is all about the parameters, which will be different for each product processed by it. The base equipment will perform standard functions in a standard way but which functions and to what degree has to be demonstrated thoroughly on multiple levels.
To keep this commentary short, simplicity is genius and Flaskworks is genius to DCVax-L processing. The complexity is not in the base equipment but in the step by step development work needed to demonstrate its appropriateness for the function and its performance to mfg quality defined product.
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