Search results for " CQA"
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
…late the quality of recombinant protein products and explore a relationship between media design and CQAs.
Media design for gaining higher productivity and modulating recombinant protein product q…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
In the initial phase, the CQAs had their criticality risk level assigned according to the severity of risk to the patient. Applying a cause-and-effect matrix approach, the potential impact of each uni…
Article
QbD and PAT in Upstream and Downstream Processing
McKnight (Genentech): CQAs are defined for the product, not identified as part of upstream or downstream portions of the manufacturing process. There are key performance indicators (KPIs) that are def…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The design space represents all combinations of CPP set points for which the CQA meets acceptance criteria.
Overall, the design space developed from process characterization study models rep…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This interpretation of CQA is most applicable to in-process and finished-product specification limits, which suggests that these limits must be critical given that they were designed to ensure product…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Input from the clinical experts is critical for successful definition of CQAs.
Critical process parameters (CPP). Once CQAs are established, process parameters from each unit operation are evalu…
Article
Critical Quality Attributes Challenge Biologics Development
The International Council for Harmonization (ICH) Q8 (R2) defines CQAs as “a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, r…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
In addition, he wrote, a list of clinical CQAs for new biologics doesn’t exist, and manufacturers typically have to wait until after a product has been commercialized to examine immunogenicity and adv…
Article
Robust Optimization, Simulation, and Effective Design Space
…velopment to identify those parts of the manufacturing process likely to have an impact on potential CQAs. Further risk assessments can be used to focus development work on areas for which better und…