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

Autor:	Duncan R. Thompson, Howard W. Ward, George L. Reid, Adrian M. Daly, Samrat Mukherjee, Mark A. LaPack, Arani Chanda, David A. Foley, John D. Orr
Rok vydání:	2014
Předmět:	Chemical process business.industry Computer science Process (engineering) Process chemistry Process analytical technology Organic Chemistry Toolbox Identification (information) Workflow Physical and Theoretical Chemistry business Software engineering Pharmaceutical industry
Zdroj:	Organic Process Research & Development. 19:63-83
ISSN:	1520-586X 1083-6160
Popis:	The IQ Consortium reports on the current state of process analytical technology (PAT) for active pharmaceutical ingredient (API) development in branded pharmaceutical companies. The article uses an API process workflow (process steps from raw material identification through to finished API) to provide representative examples, including why and how the pharmaceutical industry uses PAT tools in API development. The use of PAT can improve R&D efficiency and minimize personnel hazards associated with sampling hazardous materials for in-process testing. Although not all steps or chemical processes are readily amenable to the use of the PAT toolbox, when appropriate, PAT enables reliable and rapid (real or near time) analyses of processes that may contain materials that are highly hazardous, transient, or heterogeneous. These measurements can provide significant data for developing process chemistry understanding, and they may include the detection of previously unknown reaction intermediates, mechanisms, or re...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::25a80556abbaa8771557fd3b783dd5c4 https://doi.org/10.1021/op400358b Zobrazit plný text záznamu