According to section 3.2.S.2.2 in the DMF Technical Document Checklist annexed to the public promulgation no. DOH 1021401257, information such as "microorganism characterization" and "seed-lot system" should be provided if a drug substance is derived from fermentation process. What specific information should be provided for "microorganism characterization" and "seed-lot system"?

刊登日期:2020-07-22  |  點閱次數 : 709 次 

Microorganism characterization should include the determination of the phenotype and genotype of the microorganism. Phenotype information include macroscopic methods, microscopic methods and biochemical tests. Genotype information of the microorganism includes genetic tests. A seed-lot system includes maintenance of the master cell bank and the working cell bank. The viability and productivity of the cells under the selected storage conditions and their suitability for initiating a satisfactory production process after storage must be demonstrated. (Please refer to Ph. Eur., production of fermentation)



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