Search results for " CQA"

Article Assessing Manufacturing Process Robustness
The overall CQA variability is a function of individual component variability. Figure 1. Sources of variability. CQA is critical quality attribute. Figures courte…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
As the lead candidate enters late-stage development, several CQAs have been established (i.e., properties essential for clinical safety and efficacy), including data on how it interacts with target pr…

Article Essentials in Quality Risk Management
First, as the combination of the probability of occurrence of harm and the severity of that harm, or second, as the potential influence of product and process factors on CQAs and the uncertainty of th…

Article Quality by design for biotechnology products—part 1
Next, CQAs of the product are identified, based on the understanding of the impact of various quality attributes on the safety and efficacy of the product. The initial assessment is based on molecular…

Article Application of Quality by Design to Viral Safety
Risk analysis and scientific characterization identify those components that will have the biggest effect on process consistency and CQA. Identification of a multivariate design space in which dat…

Article Quality by Design and Extractable and Leachable Testing
The FDA guideline states that CQAs are generally associated with drug substances, excipients, intermediates, and drug product, but the concept can also be applied to container closure systems. While i…

Article Essentials in Establishing and Using Design Space
Knowledge about how X factors influence Y responses relative to CQAs is fundamental to defining and defending that knowledge. Ultimately, knowledge must be in the form of an equation (either empirical…

Article Addressing the Complex Nature of Downstream Processing with QbD
“We use the therapeutic and clinical goals of the program as defined in the QTPP to execute a risk assessment of the quality attributes to clearly define the CQAs for the process and use these as a ba…

Article Understanding Validation and Technical Transfer, Part 3
International Council for Harmonization (ICH) Q8(R2) is an excellent source of information about linking material attributes and process parameters with drug product CQAs (6). It stands to reas…

Article Leveraging Data for Better Biopharmaceutical Process Control
…om critical process parameters (CPPs) and critical quality attributes (CQAs) in real-time will allow CQAs to be estimated during processing for subsequent operations. That opens many possibilities fo…

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