Process Analytical Technology for Chromatography

Process analytical technology for chromatography.

A major United States Food and Drug Administration effort is devoted to process analytical technology (PAT), which is emerging as the likely "surprise" of the second half of the decade. PAT is an approach to monitoring, manufacturing, and other processes on a continuous rather than discrete basis. It carries the future promise of new methods of production. Building PAT into a chromatography sys...

Process analytical technology (PAT) for biopharmaceuticals.

Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production.The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel models for interpretation of systems biology data and new sensor technologies for cellular states,...

On-Line HPLC as a Process Analytical Technology (PAT) for Controlling Product Collectin from Process-Scale Chromatography Columns

Process-scale chromatography plays an important role in the purification of pharmaceutical products derived from biotechnology processes. This unit operation can be manually intensive with lengthy cycle times. This poster discusses how on-line HPLC is a tool that can be utilized to measure the product purity in near real time which can reduce product variability, increase process efficiency, an...

Process analytical technology (PAT) needs and applications

Title Process analytical technology (PAT) needs and applications in the bioprocess industry Review Abstract Process analytical technologies have been applied to manufacturing processes (pulp and paper, chemical and petroleum) for decades. Recently, the US Food and Drug Administration (FDA) has, however, redefined the phrase and implemented it into an initiative focusing on improving several asp...

Process analytical technology PAT for the life sciences industry