Process analytical technology (PAT): applications to flow processes for active pharmaceutical ingredient (API) development

被引：19

作者：

Talicska, Courtney N. ^{[1
]}

O'Connell, Eamon C. ^{[1
]}

Ward, Howard W. ^{[1
]}

Diaz, Angel R. ^{[1
]}

Hardink, Mark A. ^{[1
]}

Foley, David A. ^{[1
,2
,3
]}

Connolly, Douglas ^{[4
]}

Girard, Kevin P. ^{[1
]}

Ljubicic, Tomislav ^{[1
]}

机构：

[1] Pfizer Worldwide Res & Dev, Analyt Res & Dev, 445 Eastern Point Rd, Groton, CT 06340 USA

[2] Pfizer, New York, NY USA

[3] Merck Res & Dev, 90 E Scott Ave, Rahway, NJ 07065 USA

[4] Eurofins Sci Pfizer Worldwide Res & Dev, 445 Eastern Point Rd, Groton, CT 06340 USA

来源：

REACTION CHEMISTRY & ENGINEERING | 2022年 / 7卷 / 06期

关键词：

CRYSTALLIZATION PROCESS; CHEMISTRY; PERSPECTIVES; REACTOR;

D O I：

10.1039/d2re00004k

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

As flow processes are being increasingly utilized for development of active pharmaceutical ingredients (APIs), the importance of process analytical technology (PAT) in the pharmaceutical industry is growing. Here, we describe a variety of PAT tools (FTIR, on-line UPLC-MS, flow NMR) used in support of flow chemistry platforms at Pfizer as part of the Flexible API Supply Technology (FAST) initiative. A blend of qualitative and quantitative PAT approaches are described, with each method tailored to the specific aims of each individual platform. PAT is demonstrated to be beneficial for real-time process understanding and for rapid optimization of chemical reactions in the flow-chemistry space, reducing the need for off-line analytics and helping to accelerate development timelines.

引用

页码：1419 / 1428

页数：10

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