Can you validate my cGMP process and get my product to market faster at a lower cost?
How we said yes:
Albemarle has extensive expertise in the Design of Experiments (DoE) approach - the modern alternative to single-variable experimentation. In our research facilities, DoE is used to conduct process optimization in a rapid, responsive fashion, while supporting efforts for cGMP process validation. (The DoE approach can also be applied to non-GMP process development.) In our experience, DoE is an excellent course for facilitating reduced costs and time to market.
Current Trends in ICH Guidelines
Albemarle's DoE methods fully support the FDA ICH Quality by Design (QbD) initiative. FDA publications that have had an impact on our work:
Our approach for this particular client included:
Conducting a thorough quality risk review of the process as per the FDA's Q9 approach to risk analysis:
Three factors were tested in the context of the DoE. The process was a bimolecular reaction (A + B > C):
Three responses were tested in each of the 21 parallel experiments:
The DoE results were verified on 2-L equipment, then the information was explicitly applied to validations at 1,000- and 4,000-gallon scale.
The yes formula direct customer benefits:
Last Updated: 12/17/2013 5:35:00 PM
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