Process Validation
Process Validation
Rich Experience in Process Characterization and Validation
The development, manufacturing and quality teams of Aton have participated in 5 NDA/BLA projects of Henlius. We have rich practical experience in process characterization and process verification and can help customers with multiple services before NDA in many ways.
Process Validation Platform
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Stage 1——Process design:Based on the quality target product profile (QTPP) and potential critical quality attribute(pCQA) evaluation system as the main body, adopt international advanced FMEA tool to establish reasonable risk assessment methods, through the scientific design of experiment (DOE), and statistical analysis method to establish scaled down model (SDM), and further through process characterization experiment to obtain the critical process parameters and process control strategy（PCS）.
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Stage 2——Process performance qualification:Process performance qualification with high quality level relying on professional team and mature technology transfer platform.
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Stage 3——Continues process verification:Establish scientific and reasonable scale-up plan, effectively carry out relevant process study, reasonable alert line setting by continuously monitor commercial batch production data