Process Scale-Up And Scale-Out, Closure And Automation
Source: OmniaBio
CCRM has extensive experience in closing and automating various cell therapy processes.
- Ability to automate process unit operations and demonstrate comparability to manual processing.
- Automation permits for improved process control and reproducibility required for meeting GMP manufacturing standards.
- Optimization and translation of small scale cultures to closed, larger scale systems while improving viability, cell count, phenotype and intensifying the process. improving yield and reducing process time.
- Process closure enhances product safety by reducing contamination risk.
- Scale-up results in increased batch size reducing or eliminating the need for process scale-out reducing process foot print, time, and variability.
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