PAT Article Selected As Editor’s Choice Article
"Process Analytical Technology: Tools and Applications in API Development," (DOI: 10.1021/op400358b) recently published in Organic Process Research & Development Industry Perspectives, has been selected as an ACS Editors' Choice article.
This paper, written by the Process Analytical Technology (PAT) Working Group of the IQ Analytical Leadership Group, reviews the current state of PAT for active pharmaceutical ingredient development at innovator pharmaceutical companies. The position of the WG and its member companies is that PAT is well-integrated into drug development and manufacturing, and is being liberally practiced where and when it makes scientific and business sense. The WG aspiration from this publication was to convey, into the public domain, how and why PAT is routinely performed, and the current state of PAT in API development across IQ member companies. The article uses a typical API process workflow (process steps from raw material identification through to finished API release testing) to provide representative examples of PAT use in API development.
Publication of the article supports the IQ Consortium objectives of sharing knowledge, publicizing and promoting findings and advancing best practices leading to innovation and quality in pharmaceutical development.
As an Editors' Choice article, this article is open access. It can be read on the ACS website at: http://pubs.acs.org/doi/full/10.1021/op400358b.
A second paper is in preparation, and will report on PAT use in GMP manufacturing environments.