Industry Perspectives on Process Analytical Technology: Tools and Applications in API Manufacturing

被引：32

作者：

Bordawekar, Shailendra ^{[1
]}

Chanda, Arani ^{[2
]}

Daly, Adrian M. ^{[3
]}

Garrett, Aaron W. ^{[4
]}

Higgins, John P. ^{[5
]}

LaPack, Mark A. ^{[6
]}

Maloney, Todd D. ^{[6
]}

Morgado, James ^{[7
]}

Mukherjee, Samrat ^{[1
]}

Orr, John D. ^{[2
]}

Reid, George L., III ^{[8
]}

Yang, Bing-Shiou ^{[9
]}

Ward, Howard W., II ^{[7
]}

机构：

[1] AbbVie Inc, Proc Res & Dev, Chicago, IL 60064 USA

[2] Eisai Inc, Pharmaceut Sci & Technol, Analyt Res Lab US, Andover, MA 01810 USA

[3] Pfizer Global Supply, Global Technol Serv, Proc Analyt Sci Grp, Ringaskiddy, Co Cork, Ireland

[4] Eli Lilly & Co, Global Qual Labs, Indianapolis, IN 46285 USA

[5] Merck & Co Inc, Proc Analyt Technol, Kenilworth, NJ 07033 USA

[6] Eli Lilly & Co, Small Mol Design & Dev, Indianapolis, IN 46285 USA

[7] Pfizer Inc, Worldwide Res & Dev, Analyt Res & Dev, Groton, CT 06340 USA

[8] Cardinal Hlth Specialty Solut, Regulatory Sci, Overland Pk, KS 66210 USA

[9] Boehringer Ingelheim Pharmaceut Inc, Chem Dev Mat & Analyt Sci, Ridgefield, CT 06877 USA

来源：

ORGANIC PROCESS RESEARCH & DEVELOPMENT | 2015年 / 19卷 / 09期

关键词：

Application programming interfaces (API);

D O I：

10.1021/acs.oprd.5b00088

中图分类号：

O69 [应用化学];

学科分类号：

081704 ;

摘要：

The IQ Consortium reports on the current state of process analytical technology (PAT) for active pharmaceutical ingredient (API) manufacturing in branded pharmaceutical companies. The article describes the application of PAT in manufacturing and provides representative examples in four common pharmaceutical unit operations: reaction and workup, crystallization, drying, and milling.

引用

页码：1174 / 1185

页数：12

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