Search results for " CQA" in Articles / App Notes
Article
N-Glycan Analysis of Biotherapeutic Proteins
…uch, when ADCC constitutes the mechanism of action, the presence of high-mannose-type N-glycans is a CQA.
As shown in Figure 1B, there are non-human or immunoreactive N-glycan structures th…
Article
The Metrics of Quality Culture
Upon closer evaluation, however, it is clear that FDA is trying to measure whether a company drives for continuous improvement through their review and assessment of threshold levels established with …
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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
Table II illustrates considerations relating to CQAs and CPPs for cleaning processes. Table III illustrates considerations relating to cleaning-process design.
The four principal cleaning-input par…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
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…
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Establishing Acceptance Criteria for Analytical Methods
…es of analytical method goodness to measures that have product relevance links method performance to CQAs and their associated specification limits in a way that nothing else will. Knowing how method…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Most often, there is not much patient data from the clinical studies or adverse events cannot be directly linked to specific CQA levels. The uncertainty factor often outweighs any available data or kn…
Article
Evaluating Design Margin, Edge of Failure and Process
Process Capability and Failure Rates
Process capability is a measure of the ability of the process to produce product that meets all CQAs and acceptance criteria (3). The ISO definition is “Process …