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…
Article
Setting Up Bioprocessing Systems for Digital Transformation
“AI in its classical sense is based on a statistical ‘black-box’ approach: statistical approaches such as big data or machine learning utilize statistics to predict correlations, trends, and patterns.…
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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
The authors believe the industry will see a rise in modeling during the next decade as the biotech industry attempts to institutionalize the principles of QbD and PAT and moves towards continuous proc…
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Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
By Caroline Hroncich
On Dec. 23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discuss…
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Use of Multivariate Data Analysis in Bioprocessing
Conclusion
With continued efforts towards implementation of QbD and PAT in the biotech industry, MVDA is expected to continue to serve as an enabler of this change. The authors see great scope for…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
The key PAT concepts, namely real-time product quality-based decision making, is central to success of a continuous manufacturing program.
Read More Q&As With Industry Leaders Here
Article
Challenges of Protein Aggregation During Purification
Benefits of PAT
Advances in process analytical technology (PAT) provide an opportunity for more effective control of protein aggregation in bioprocessing, according to Vedantham. “Dynamic light sc…