The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations
The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations
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DOI：
10.1021/acs.oprd.8b00160
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发表时间：
2018-09-01
影响因子：
3.4
通讯作者：
Braden, Timothy M.
中科院分区：
文献类型：
--
作者：
McWilliams, J. Christopher;Allian, Ayman D.;Braden, Timothy M.
本手稿提供了对制药行业连续加工的能力、经验和观点进行深入调查评估的结果，受访者来自制药公司和合同制造组织 (CMO)。该调查包括人员配置（人员）、化学、反应平台、反应后处理、分析、监管以及影响连续制造采用的因素。调查结果表明，该行业以连续流程执行的总制造比例一直在增加，并将继续增加，而批量处理则会减少。一般来说，大规模连续处理的大部分经验都有助于反应化学，而后处理和分析仍处于开发和实施的早期阶段。
This manuscript provides the results of an in-depth survey assessment of the capabilities, experience, and perspectives on continuous processing in the pharmaceutical sector, with respondents from both pharmaceutical companies and Contract Manufacturing Organizations (CMOs). The survey includes staffing (personnel), chemistry, reaction platforms, postreaction processing, analytical, regulatory, and factors that influence the adoption of continuous manufacturing. The results of the survey demonstrate that the industry has been increasing, and will continue to increase, the portion of total manufacturing executed as continuous processes with a decrease in batch processing. In general, most of the experience with continuous processing on scale have been enabling reaction chemistry, while postprocessing and analytical remain in the very early stages of development and implementation.