How does Cell Culture Solutions design experiments?
A. Experimental design and data analysis are performed using “Design-Expert” statistical software from Stat-Ease, Inc. By combining our expertise in cell culture with DOE techniques, we are able to design experiments that provide valid and objective conclusions. Q. Is the statistical software properly validated? A. Stat-Ease, Inc. uses several validation procedures to test its software. Because the FDA’s 21 CFR Part 11 ruling does not apply to the software, it can be used for developmental and validation studies in the biopharmaceutical industry. In fact, the DOE approach is part of a set of tools recommended by the CBER/FDA for the Process Analytical Technology (PAT) Initiative. The goal of PAT is “to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process”. When designing experiments using statistical tools, Cell Culture Solutions will ensure that compliance issues are thoroughly reviewed with customers before issuing a D
