Search results for " capture"
Article
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…
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The Affordable Care Act's Impact on Innovation in Biopharma
With an increasing emphasis on post-market safety surveillance and real-world evidence, companies must have the appropriate measures put in place to capture this information.
• Clinical groups wil…
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Trends in Downstream Bioprocessing
At present, most industry decision-makers find current Protein A, particularly, in the US and EU (versus the rest of the world), to be an adequate, if expensive, solution for antibody capture. Alterna…
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FDA Seeks Metrics to Define Drug Quality
The next level captures higher average disposition cycle times or operator errors per batch. Documented quality events, overdue regulatory commitments, or an increase in rejected batches may signal th…
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QbD and PAT in Upstream and Downstream Processing
Not all of these are amenable for online applications, but together they capture various attributes of upstream processing.
BioPharm: Given the inherent variability in biologics manufacturing, how…