1 We comply the rules of pharmaceutical process development
Small-scale process studyPilot-scale process developmentGMP process validation
Small-scale process study:To research and determine the key process steps and factors which critically effect on product quality through small scale experiment, and to screen or optimize the process parameter.
Cell culture experiment Viral amplification experimentPurification experimentProduct detection method studySmall-scale process assessment Evaluation for industrialization
Pilot-scale process development： According to the experimental results and the experience of amplification, simulation the production in the pilot scale, and to determine the key process steps and scope of operating parameters, the main equipment,
and the quality control of raw materials and intermediates that planning to be used in the large scale production, etc.
Pilot scale selectionPilot process optimizationPilot process experiment Pilot process assessment
GMP process validation：Accordance with the pilot scale production, to validate the feasibility and reproducibility of the process under the condition of GMP production.
GMP auditThree batches production validationProcess stability assessment