Search results for "PAT"
Article
2014 Manufacturing Trends and Outlook
Process analytical technologies
More than half of the respondents reported using process analytical technology (PAT) in manufacturing operations. High-performance liquid chromatography was th…
Article
Essentials in Quality Risk Management
… definition, analytical method, and associated process changes are understood and managed to ensure patient safety and drug efficacy. An effective QRM process can further ensure the high quality of t…
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Advancing QbD in the EU
In 2003, EMA set up a team to back activities in process analytical technology (PAT) in the EU. The agency has seen its PAT team as a key element in the implementation of QbD by encouraging process un…
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Report from the 12th Plasma Product Biotechnology Forum
Despite the unusual raw material, there is a well-established and understood regulatory pathway through FDA-CBER. SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase …
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
One of the most important applications that I anticipate is the early sort out of hard to purify molecules. As mechanistic modeling uses only few calibration experiments, the realization that uneconom…
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Achieving Process Balance with Perfusion Bioreactors
Advances made in process analytical technology (PAT) tools and bioprocess software also enable implementation of perfusion processes in stainless-steel bioreactors. Adams points to glucose and lactate…
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Hybrid Bioprocessing: A Q&A with Andrew Sinclair
It has the potential for a step change though in my view, it will require innovative thinking around, automation, PAT, and online release to realize its full potential.
It is often stated that con…
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Being Thorough When Transferring Technology
Fortunately, some of these can be anticipated and planned for in advance. This requires an understanding of what the rate limiting or controlling phenomena are and at each scale. What is limiting or r…
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Automating Bioprocesses
In addition, good process analytical technology (PAT) and ‘soft sensors’ (i.e., predicting values based on modeling) are important to ensure product quality. It is important to understand how disturba…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…titious viral agent contamination and to ensure uninterrupted supply of safe biological products to patients in need.
Product safety and quality by design (QbD)
Traditionally, product safety …