Search results for " PAT"

Article Moving PAT from Concept to Reality
With sufficient advances, emerging PAT solutions should ultimately make real-time release testing possible. In-line, at-line, and on-line To understand the state of PAT technology development, i…

Article Improving PAT for Biologics
Implementing PAT for bioprocesses presents unique challenges given the greater complexity of cell-culture and fermentation processes, the variability of raw materials (particularly living organisms), …

Article QbD and PAT in Upstream and Downstream Processing
Some of these CQAs, such as glycoxylation pattern for monoclonal antibody (mAb) products, are primarily impacted by the upstream process and are particularly important to monitor during process develo…

Article Tools for Enabling Process Analytical Technology Applications in Biotechnology
In this paper, the authors review the various analytical methods that can enable use of PAT. A critical evaluation of suitability of each analytical method as a PAT tool in terms of sampling (in-line,…

Article Leveraging Data for Better Biopharmaceutical Process Control
Biopharmaceutical companies are starting to use PAT in more advanced development and even some manufacturing work, while methods are also moving downstream. Francisca F. Gouveia, a biopharmaceutical p…

Article The Lifecycle Change of Process Validation and Analytical Testing
Therefore, finding a balance between relying on semi-automated statistical tools and human monitoring is potentially one of the key elements to success APPLYING PAT   BioPharm: How ma…

Article QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…

Article Improving Upstream Predictability
Leveraging PAT and sensor technology, it will feature a modular design and use portable 2000-L bioreactors and vessels and single-use bioreactors. At the contract development and manufacturi…

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
“Inline monitoring and real-time control of critical nutrients such as glucose and glutamine lead to more optimal and robust processes, and there is an increasing trend to adopt such PAT methodologies…

Article Making the Move to Continuous Chromatography
Some systems come with flow paths that are designed to be cleaned and reused, while others are flow paths that are single-use. Some systems come with dynamic control functionality—process analytical t…

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