Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs
Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs
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DOI：
10.1016/j.jcyt.2012.09.006
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发表时间：
2013-03-01
期刊：
影响因子：
4.5
通讯作者：
Reinke, Petra
中科院分区：
文献类型：
--
作者：
Abou-El-Enein, Mohamed;Roemhild, Andy;Reinke, Petra
背景目标。先进治疗药物（ATMP）由于其治疗潜力而在学术界获得了相当大的关注。良好生产规范（GMP）原则确保了这些产品的质量和无菌生产。我们开发了一个模型来估计细胞治疗产品的制造成本并优化学术GMP设施的性能。方法.在德国柏林BCRT的GMP工厂前瞻性检测了“洁净室技术评估技术”（CTAT），然后在美国加州加州大学戴维斯分校的GMP工厂进行了回顾性检测。CTAT是一个两级模型：第一级确定业务（核心）流程并计量其固定成本;第二级确定生产（辅助）流程并计量其可变成本。该模型包括几个工具来衡量和优化这些过程的性能。制造成本采用调整后的微观成本计算系统逐项列示。结果CTAT确定GMP活动与基于细胞的产品的生产工艺密切相关。建立最佳做法标准有助于提高业绩和消除人为错误。该模型还显示了可能存在于核心GMP活动之间的单向依赖关系。与传统的商业模式相比，CTAT评估导致了更准确的年度费用分配。估计费用用于设定两个GMP设施的费用结构。还开发了一个数学方程来提供最终产品成本。结论. CTAT可以是一个有用的工具，估计在优化的GMP过程中生产的ATMP的准确成本。在分析这些新干预措施的成本效益时，这些估计是有用的。
Background aims. Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. Methods. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. Results. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. Conclusions. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions.