Search results for " capture" in Articles / App Notes
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Management reviews need to capture and aggregate risks across manufacturing campaigns to mitigate potential risks during changeover. In general, a biopharmaceutical manufacturer faces similar business…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
As one example of how Fujifilm is using technology to address current challenges, Bird cites the company’s “TAG” system for digitally managing the capture, conveyance, and retention of manufacturing k…
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Biomanufacturing Outsourcing Globalization Continues
Conclusion
CMOs and contract research organizations based in emerging markets will continue to capture market share, albeit slowly. These CMOs continue to face domestic regulatory and legal hurd…
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Optimization of Protein Expression in Escherichia Coli
For example, for proteins synthesized with targeting signal sequences, the tag should be located at the C-terminus to avoid mis-targeting and to ensure mature protein capture, especially if the signal…
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Continuous Chromatography: Trends, Definitions and Approaches
All of the acronyms describe the same thing: a chromatography capture step-based utilizing multiple columns operated in a merry-go-round manner, where columns moved against the direction of feed flow.…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Such standards will aim to capture critical product attributes that can indicate quality problems, needed corrective actions, and justify enforcement decisions. OPQ’s Office of Policy for Pharmaceutic…
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Tackling Analytical Method Development for ADCs
One approach is to use hybrid techniques such as affinity capture LC-MS/MS, but that adds complexity to the analysis. A combination of immunoassay and LC-MS/MS techniques can also be used in addition …
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Optimizing Resin Performance with Disposable Chromatography Solutions
It is important to note that other savings are possible and are not captured by the calculator: How often does a pack fail? Are some resins more difficult than others? If as a user you pack columns in…
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Challenges of Protein Aggregation During Purification
Protein A chromatography is often used as a capture step and provides for the significant removal of impurities from the cell culture. The product is eluted at low pH and then often subjected to a low…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The fact that a highly critical attribute is easily controlled through the process, even to the point of not requiring routine testing, should be captured separately in process risk assessments and in…