Posts Tagged ‘Process Analytical Technology’

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
Tags: , , , , , , ,

It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]

Trends in the Life Sciences Industry

Posted in Life Sciences on Thursday, June 23rd, 2016. 2 comments so far
Tags: , , , , , , ,

For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes. I caught up with Emerson’s Michalle Adkins who shared these trends with me. She identified six major areas: continuous manufacturing, single use technology, biosimilars & generics, personalized medicine, demographic shifts, and taking […]

Accurate and Repeatable Measurements in Pharmaceutical and Biotech Manufacturing

Posted in Life Sciences, Pressure on Tuesday, March 15th, 2016. No comments yet
Tags: , , , , , ,

A Pharmaceutical Manufacturing magazine study revealed that pharmaceutical and biotech manufacturers were challenged to achieve batch after batch repeatability. I came across a recently published whitepaper, Consistency and Repeatability Through Accurate Measurements. Emerson’s Michalle Adkins played a role in its contents. The whitepaper highlights: …how reliable, accurate instrumentation allows automation to support quality and productivity […]

Is Process Analytical Technology Rocket Science?

Posted in Life Sciences on Thursday, January 21st, 2016. No comments yet
Tags: , , , ,

More than a decade ago, the U.S. Food and Drug Administration published, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. In this document, the FDA explained: The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, is intended to support innovation and efficiency in pharmaceutical […]

Online Multivariate Data Analysis for Continued Process Verification

Posted in Life Sciences on Thursday, January 7th, 2016. No comments yet
Tags: , , , , , , ,

Measuring quality in real-time improves the overall performance of a manufacturing process. The International Foundation Process Analytical Chemistry (IFPAC) is: …a world-wide, not-for-profit organization dedicated to the advancement of Process Analytical Technology and Chemistry. They are holding the IFPAC Annual Meeting later this month in the Washington D.C. area. This meeting provides a forum for […]