Seed lot system

Production is based on a validated seed-lot system using a host-vector combination that has been shown to be suitable to the satisfaction of the competent authority. The seed-lot system uses a master cell bank and a working cell bank derived from the master seed lot of the host-vector combination. A detailed description of cultivation, extraction and purification steps and a definition of the production batch shall be established. 

The determination of the suitability of the host-vector combination and the validation of the seed-lot system include the following elements. 

The method of manufacture section should also include a subsection on the cell seed lot system, which should address three items ... 

Seed lot system for cells and microorganisms with complete history, genotypic and phenotypic characterization stability of seed lot beyond passage level used for production. Freedom from potentially pathogenic adventitious agents or validated inactivation or elimination procedures with sufficient safety margin. 

Seed lot system for cells and microorganisms with complete history, passage limitations. 

The production of a rDNA product should be based on a seed lot system involving a manufacturer s working cell bank derived from the master seed lot A host cell containing the expression vector should be cloned and used to establish a master seed lot During the establishment of the seed, no other cell lines should be handled... 

Additionally, special consideration should be given to starting materials, media and the use of a seed lot system. 

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