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14 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Design of Experiments F irst developed in the 1920s, design of experiments (DoE) has become an indispensable tool for drug developers who seek to gain deeper insights into their products and pro- cesses. Instead of taking a univariate approach, changing one factor at a time and studying the impact on results, DoE uses statistical methods to perform multivariate analysis. This approach allows users to assess the impact of various factors on each other and on an outcome or product, allowing them all to be studied all at once (Sidebar). Applied by Toyota engineers to understand the impact of variabil- ity on product quality, the method was first used for chemical devel- opment in the 1950s. Over the past few decades, its use in pharma- ceutical development has grown dramatically, spurred by guidelines such as International Council for Harmonization (ICH) Q8 (R2), and FDA-driven initiatives such as process analytical technology (PAT) and pharmaceutical quality by design (QbD). Although the mathematical underpinnings of DoE have been around for a hundred years, advances in computing and graphics, and software improvements made by vendors such as Umetrics, JMP, Stat-Ease, SaaS, and Camo have increased the power and user-friend- liness of DoE software, according to spectroscopist and PAT expert Emil Ciurczak, head of DoraMaxx Consulting. Combined with the miniaturization of analytical instrumentation and the increasing sophistication of PAT, users can now run complex studies within labs or on the plant floor, and get results that would once have taken weeks, within days. WDNET STUDIO - STOCK.ADOBE.COM Design of Experiments Gains Ground in Biopharma Development Agnes Shanley Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development, as equipment evolves and use of PAT increases.