From Design of Experiments to Design Space in MODDE® 12

From Design of Experiments to Design Space in MODDE^® 12

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The process window in production is a volume defined by several critical process parameters and/or material attributes. It is challenging and expensive to find the process window in full scale. Hence, for decades, Design of Experiments (DOE) has been used on a smaller scale in order to get a first estimate the process window.

For pharmaceutical companies guidelines Q8-Q12 were released by ICH in 2004. In 2009 ICH Q8 R2 was released followed in 2013 by FDA to state that it expects generic drug manufacturers to implement Quality by Design (QbD) into their Abbreviated New Drug Applications (ANDA).

Many of the guidelines from ICH and FDA are general and the graphs in ICH Q8 R2 can be interpreted in several ways. Sartorius Stedim Data Analytics (SSDA) have discussed with many customers knowledgeable about statistics and regulatory procedures and have implemented the Design Space functionality in MODDE^® 12.

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