Issue link: https://www.e-digitaleditions.com/i/1495138
4 BioPharm International ® Quality and Regulatory Sourcebook March eBook 2023 www.biopharminternational.com P rogressing a drug candidate from research to commercialization requires huge sums of money (approximately US$1.5 bil- lion–$4.5 billion) (1) and is inherently high risk due to the high attrition rate. Only approx- imately 10% of total drug attrition is because of poor strategic planning or a lack of commercial needs (2). Highlighting solid strategy and fund- ing alone is not enough to take a drug to market. Approximately 70–80% of clinical failures can be at- tributed to a lack of clinical efficacy or toxicity (3), and the majority of drug failures occurring in pre-clinical and Phase I are due to pharmacokinetics or toxicity issues (4). There are many strategies that are employed to optimize the return on investment; one of which is simply to avoid overspending in early development, which is enabled by effective and structured develop- ment of chemical and analytical processes through- out drug development. The importance of quality-consistent material throughout development Synthesis development and associated analytical pro- cedure development are the starting points for every new pharmaceutical product entering the develop- ment phase. The development phase occurs under huge time-pressure, as (pre)clinical material is re- quired as soon as possible to reach the next milestone. Yet, developing a new route for batches in development is nearly always preferred over continuation with the 'research route' because: • (Pre)clinical development studies require much larger amounts of the drug candidate than are re- quired during the research phase. The 'research route' often has a design or contains chemical steps that have too low yield/too high cost or is not safely scalable to large amounts. • The material used throughout the development of a pharmaceutical compound needs to be of con- sistent quality in terms of structure/composition, Phase-appropriate Analytical Methodology Paul Van Tilborg is director of analytical sciences at Ardena. A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances. MURRSTOCK - STOCK.ADOBE.COM