Search results for "CQA"
Article
The Metrics of Quality Culture
The third quality-culture optional metrics involves trying to use critical quality attributes (CQA) as a key indicator of a quality culture. Of the three optional metrics proposed, this one does provi…
Article
Continuous Chromatography: Trends, Definitions and Approaches
One can envision that future process control will be based on algorithms that will operate the process in a state where a product’s CQAs are not affected and that the process is operated at its curren…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Appropriate control of CQAs is a common review concern for both investigational new drug (IND) and license applications.6,7 Product quality characteristics encompass a wide variety of product variants…
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PDA's Technical Report for Biotech Cleaning Validation
A key to cleaning-process design is an understanding of the cleaning process itself, including critical quality attributes (CQAs) related to the outcome of the cleaning process, as well as critical pr…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Thus, glycan structure is a critical quality attribute (CQA) that must be monitored during drug manufacturing.
Glycan composition profiling is commonly used to track the structural diversity of…
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
For example, it can be challenging to score and rank meaningfully the critical quality attributes (CQA) when developing a control strategy. Most often, there is not much patient data from the clinical…
Article
Evaluating Design Margin, Edge of Failure and Process
…ilure or high amounts of degradation) can be processed and achieve all critical quality attributes (CQAs) and associated product acceptance criteria. Knowledge of product or process acceptance criter…
Article
Implementing QbD in Sterile Manufacturing
Critical quality attributes
BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing?
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