Avoiding Potholes in Process Development Part IV: Safety Testing for Drug Products



July 27, 2015

Regis Technologies hosted a seminar with guest speaker Neal G. Anderson, Ph.D., on Avoiding Potholes in Process Chemistry. This talk discussed how to anticipate and avoid problems in process development. This fourth installment of the five videos covers FDA requirements, potential genotoxic impurities, and toxicity. A full abstract follows: The first questions that a scale-up organization asks are: How much material is needed? How soon? For what purpose? All processes are developed to be fit-for-purpose, with different requirements at different stages of development. Safe operating conditions must be identified for effective scale-up; perhaps continuous flow chemistry offers advantages, or the chemistry could be outsourced to CROs that specialize in handling energetic chemistry. Mass transfer, heat transfer, and extended operating times can impact scale-up. Workups must be designed to thoroughly quench reagents and ideally deliver the product without decomposition. For early Phase studies products can be purified by chromatography, later perhaps by extraction and crystallization. The stability of intermediates can pose problems. Thorough analytical investigations are justified to unambiguously identify compounds. Screening for the optimal final form should be carried out early, unless the product is an oil or a lyophile. Structurally related impurities, potentially mutagenic impurities, and residual elemental metals must be controlled. As a compound progresses towards commercialization processes are developed to be more cost-effective.

Drug Discovery

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