期刊
MABS
卷 12, 期 1, 页码 -出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/19420862.2020.1754999
关键词
Process development; manufacturing costs; biopharmaceutical; drug development cycle; chemistry; manufacturing and controls; clinical success rates; phase transition rates
资金
- UK Engineering and Physical Sciences Research Council (EPSRC)
- AstraZeneca [EP/L01520X/1]
- [EP/P006485/1]
- EPSRC [EP/P006485/1] Funding Source: UKRI
This study aims to benchmark and analyze the process development and manufacturing costs across the biopharmaceutical drug development cycle and their contribution to overall research and development (R&D) costs. This was achieved with a biopharmaceutical drug development lifecycle cost model that captured the costs, durations, risks and interdependencies of the clinical, process development and manufacturing activities. The budgets needed for process development and manufacturing at each phase of development to ensure a market success each year were estimated. The impact of different clinical success rate profiles on the process development and manufacturing costs at each stage was investigated, with a particular focus on monoclonal antibodies. To ensure a market success each year with an overall clinical success rate (Phase I to approval) of similar to 12%, the model predicted that a biopharmaceutical company needs to allocate process development and manufacturing budgets in the order of similar to$60 M for pre-clinical to Phase II material preparation and similar to$70 M for Phase III to regulatory review material preparation. For lower overall clinical success rates of similar to 4%, which are more indicative of diseases such as Alzheimer's, these values increase to similar to$190 M for early-phase and similar to$140 Mfor late-phase material preparation; hence, the costs increase 2.5 fold. The costs for process development and manufacturing per market success were predicted to represent 13-17% of the R&D budget from pre-clinical trials to approval. The results of this quantitative structured cost study can be used to aid decision-making during portfolio management and budget planning procedures in biopharmaceutical development.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据