Search results for " system" in Articles / App Notes
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Many single-use consumable supply partners now offer large customized system designs that can be tailored exactly to a specific workflow. Having an all-encompassing single-use system for a unit operat…
Article
Quality by Design and Extractable and Leachable Testing
The FDA guideline states that CQAs are generally associated with drug substances, excipients, intermediates, and drug product, but the concept can also be applied to container closure systems. While i…
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Challenges in Analytical Method Development and Validation
The robustness of methods is particularly discussed in the new draft guidance, and a systematic approach for method robustness study (e.g., design of experiments) should be adopted to ‘fully understan…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
It is, therefore, important to have a systematic and quantitative assessment of quality attributes to pick out those that are crucial based on their clinical relevance. These critical attributes are o…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Single-use systems are well accepted in today’s manufacturing industry and their widespread use is driven by benefits such as reduced and delayed capital investments as well as by a shift from fixed c…
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Evaluating the Use of Continuous Chromatography
…romatography differs from traditional ‘batch’ chromatography in two key ways: the chromatography system can be loaded continuously, which is a useful approach when the purification step is connected …
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Bracing for a Future Wave of Advanced Therapies
“The good news is healthcare systems have worked through this before. They’re adapting right now, I would argue, led by the commercial payers, and we will work through these challenges yet again,” Hun…
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Maximum Output Starts with Optimized Upstream Processing
On a positive note, parallelization of experiments using automated systems for high-producer clone selection, along with medium optimization and the availability of standard kits, are having an overwh…
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Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
If we think of this as being a way of simulating chromatograms with the help of the computer, you take data related to your chromatography system, to your column, and to the separation that you're doi…
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Good Manufacturing Practices: Challenges with Compliance
Problems can arise when different sponsor companies have different requirements for their quality systems, or if their requirements differ from Catalent’s requirements.
In manufacturing, it is i…