Application of the DoE Concept for Peptide API Process Development at Bachem
Daniel Samson, Wolfgang Seufert, Matteo Villain, Alex Fässler · 2015
ICH guideline Q11 [1] describes approaches to developing process and drug substance understanding. In a traditional approach, set points and operating ranges for process parameters are defined, and the drug substance control strategy is typically based on demonstration of process reproducibility and testing to meet established acceptance criteria. In an enhanced approach, risk management and more extensive scientific knowledge are used to select process parameters and unit operations that impact critical quality attributes (CQAs) for evaluation in further studies to establish design space(s) and control strategies applicable over lifecycle of the drug substance [1].