Search results for "PAT"
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QbD Improves Cell-Culture Process Control
Real-time quality control
Integrating process analytical technology (PAT) into the bioproduction process enables the biomanufacturer to move from a quality-by-testing approach to a QbD approach, w…
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Improving Upstream Predictability
“Using automation, process analytical technologies (PAT), and advanced multivariate analysis has enabled the industry to control process performance and product quality more closely than ever before,”…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
By identifying those process parameters that are critical to getting product with desired quality attributes, process analytical technology (PAT) and realtime process control play a role in optimizing…
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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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Evaluating Surface Cleanliness Using a Risk-Based Approach
…nclude the concepts of quality by design (QbD), risk management, and process analytical technology (PAT) (5, 6). The purpose of these guidance documents is to promote enhanced understanding of produc…
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A Look Ahead at BioPharma Manufacturing and Regulation
The overall effort builds upon the agency's Critical Path Initiative, launched in 2004, to drive innovation in scientific processes, which includes the 2011 report that prioritized eight areas, which …
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Cell-Culture Advances Test Bioreactor Performance Models
“Successful modeling of bioreactors can reduce costs associated with engineering testing and engineering runs, accelerating pathways through preclinical and early clinical phases,” adds Mark T. Smith,…
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Technologies and Practices Must Evolve to Meet Demand
Nearly two-thirds of the 2015 respondents reported that they employ process analytical technology (PAT). More than 42% cited better process understanding and increased efficiency or reduced waste as p…
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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Regulatory Challenges in the QbD Paradigm
The past five years have seen QbD gaining widespread adoption in the biopharmaceutical industry with several publications attempting to elucidate a path forward for its implementation and resolution o…