Search results for " critical quality attribute"

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A process parameter whose variability has an impact on a critical quality attribute and, therefore, should be monitored or controlled to ensure the process produces the desired quality. • Critic…

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 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 Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics. By Susan Haigney Critical quality attributes (CQAs) are used in biop…

Article Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
As Jose Menezes, CEO of 4Tune Engineering, pointed out in a white paper (1), biologics can have a million times more critical quality attributes (CQAs) than small molecules, and many more of them are …

Article Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
The development process should identify and describe the critical quality attributes and critical process parameters that influence product quality and performance.  pharmacodynamics Study of the …

Article Regulatory Challenges in the QbD Paradigm
Expanded change protocols describe the holistic QbD and risk-based approaches to demonstrate the lack of adverse effect on safety and efficacy of a product and focus on critical quality attributes. Su…

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 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 …

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