Search results for "CQA"

Article Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…

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Article Determining Criticality, Part Two: DoE and Data-Driven Criticality
In Part I of this series, the author introduced the concept of continuum of criticality and applied it to the concepts of critical quality attributes (CQAs) and critical process parameters (CPPs). In …

Article QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture? Vanden Boom (Hosp…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In fact, the design space is not defined by the combination of the PARs for each CPP, given that the full PAR for one CPP ensures the quality of the critical quality attribute (CQA) only when all othe…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
• Critical quality attribute (CQA). A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the des…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
This process helps in identifying the critical quality attributes (CQA) and is a joint effort between the client and the CMO. CQA. CQAs are defined through execution of a risk assessment, which ev…

Article Critical Quality Attributes Challenge Biologics Development
By Susan Haigney Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
A critical quality attribute (CQA) has been defined as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distributi…

Article Robust Optimization, Simulation, and Effective Design Space
Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, and material attributes is a primary goal of drug development. Even though there are ICH guidance doc…

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