Search results for " control" in Articles / App Notes
Article
Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This opens a wide range of model applications—from early-stage process development via process characterization to process monitoring and control.
GoSilico has developed the ChromX™ software. What…
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The Importance of Partnering for Bioanalytical Studies
A listing of assay performance characteristics, which include tables of assay control results, run summaries, and calibration curve results, are typically provided. Additional information, such as inc…
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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The Need for Advanced Process Modeling for New Therapeutic Biologics
There should also be an emphasis on product understanding and process control, and that the design of a process should be grounded in “sound science” and quality risk management (1).
FDA has no…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
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Along with the previously mentioned pieces, the following articles were among the most popular published in 2019:
Are You in Control of the Q…
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Biosimilar Quality Requirements
The document also provides recommendations to sponsors on what scientific and technical information to include for the chemistry, manufacturing, and controls (CMC) section of a marketing application f…
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Best Practices for Selecting a Top-Quality Cell Line
“A high-quality cell line should be well-rounded among the critical chemistry, manufacture, and control (CMC) production cell line attributes,” agrees Jill Cai, vice-president of cell and protein scie…
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Driving Improved Access to Biosimilars
However, she suggests, “At this point, there are still too many things that we cannot measure or control, to be talking about interchangeability.”
Magil also questions the idea of biosimilar de…
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Emerging Therapies Test Existing Bioanalytical Methods
The first consideration is the development of reagents to be used as controls within the assays. The time upfront in production and characterization of high-quality reagents will result in reduced cos…