Search results for "PAT"
Article
Maximum Output Starts with Optimized Upstream Processing
CDMOs [contract development and manufacturing organizations] must provide flexibility to address bottlenecks, like taking the most streamlined path possible, decoupling upstream and downstream process…
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Setting Up Bioprocessing Systems for Digital Transformation
Lenich says that with the increased complexity inherent in mAb manufacturing, there is a new focus on process analytical technology (PAT) to ensure that not only are measurements correct, complete, an…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
Despite acknowledgment of how valuable process analytical technology (PAT) is to various biomanufacturing processes, the industry has been somewhat slow to adopt PAT-focused platforms and services for…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Modeling can make process robustness studies more efficient, aid process monitoring efforts, and can facilitate implementation of process analytical technology (PAT). The authors believe the industry …
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Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
According to the agency, to participate in the new FDA program, applicants must submit a written request for a Type C meeting to CDER-ETT@fda.hhs.gov. Requests can include an explanation of the new te…
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Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
…anufacturing was pushed by QbD implementation, in particular that of Process Analytical Technology (PAT). The key PAT concepts, namely real-time product quality-based decision making, is central to s…
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Challenges of Protein Aggregation During Purification
Refolding may lead to formation of aggregated species due to off-pathway reactions.
Finally, during downstream processing of proteins, due to the discrete nature of unit operations execution, prod…