Speeding Drug Development through Impurity Control Strategies

Dr. Steven Baertschi delivered this talk in South San Francisco, CA on October 31, 2018. Development and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety. Existing guidelines for control of new impurities in drug substances and new drug products (ICH Q3A/Q3B, USP Chapters 476 & 1086) apply to commercial products or products in late-stage clinical development (Phase 3). In addition, guidance for mutagenic impurities (ICH M7), which covers early clinical development through commercialization, is a relatively new guideline and questions regarding its implementation remain. The lack of regulatory guidance regarding impurity controls at early stages of clinical development (prior to Phase 3) provides both questions and opportunities for the development of effective control strategies. This talk focuses on risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. Relevant examples and references are provided.