Process analytical technology (PAT) for biopharmaceuticals
نویسندگان
چکیده
منابع مشابه
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,...
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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...
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O ur ability to develop advanced bioprocess control and optimization strategies is directly linked to the availability of relevant in situ sensors or real-time analytical instrumentation and, as such, was identified as a research funding priority by the National Science and Technology Council in 1995 (131). Demand for rapid monitoring techniques is being driven by • a need to build better proce...
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Process Analytical Technology (PAT) promise to deliver a bigger, brighter future in terms of encouraging “the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance” while ensuring patient safety and increasing profitability for the life sciences industry. No matter how you slice it, reducing raw material and batch losses, preventi...
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ژورنال
عنوان ژورنال: Biotechnology Journal
سال: 2011
ISSN: 1860-6768
DOI: 10.1002/biot.201000356