- Experimental designs for process development and characterization studies
- Integrated process modeling
- Customized statistical methods for process development and characterization studies
- Scale-down model evaluation
- Accelerated and unbiased risk analysis
- Data-driven risk rankings to enable linkage with development and product data
Would you like to know how to successfully validate your processes, achieve regulatory filing and further improve the quality of your products? Use our process knowledge and statistical toolbox to gain deeper insights into your processes.
To do this, we combine biotechnological process knowledge with state-of-the-art data analysis methods. Benefit from our experience in the entire process lifecycle: process characterization, process performance qualification and continued process verification. By applying statistical best practices and our expert knowledge, you efficiently validate your processes and optimize individual process steps in a targeted manner. In this way, you improve the quality of your products, increase productivity and have clear lines of argumentation in interactions with the regulatory authorities (FDA, EMA, etc.).
Ensure reliable process characterizations, rapid technology transfers, robust quality controls, and compliant process validation campaigns.