Search results for " 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
Also Popular on Bioprocess Development Forum
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…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
For example, the ability to use concentrated buffer components and mix them in-line under controlled conditions (i.e., in-line conditioning) has simplified chromatographic operations (2).
“Single-u…
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Successfully Moving Regulated Data to the Cloud
…re, or are turning to vendors that provide software-as-a-service (SaaS), which provides the ultimate control when it comes to flexibility by allowing organizations to pay for what they use. As well a…
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Security of Supply
This shared understanding leads to supply chain control, and digital makes it possible.
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
This article focuses on concentration assays used for drug product characterization and quality control.
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