Search results for " critical quality attribute"
Article
Monitoring and Control of Inline Dilution Processes
Monitoring and control
When looking at the buffer preparation process, the target product profile should be defined first followed by critical quality attributes and critical process par…
Article
Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…
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QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
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Reimagining Affordable Biosimilars
The critical quality attributes of a product are defined as physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distr…
Article
Digitalization: The Route to Biopharma 4.0
Researchers have attempted to create mechanistic models that can predict the impact of major process variables (5) on the critical quality attributes (CQAs) (6); however, these mechanistic models are …
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
Article
Leveraging Data for Better Biopharmaceutical Process Control
As data management becomes more sophisticated, the possibility of retrieving and aggregating data from critical process parameters (CPPs) and critical quality attributes (CQAs) in real-time will allow…
Article
DoE Provides Benefits, but Preparation Is Necessary
Yang agrees that the typical subset of critical quality attributes of the formulated product that are assayed in a DoE study may not be comprehensive enough to cover some of the quality changes that c…