Search results for " attribute"
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
…10 (2-4), many companies are challenged by the evolving concept of criticality as applied to quality attributes and process parameters. Historically, in biopharmaceutical development, criticality has…
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 Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…
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
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Complexity—in particular, determining which product attributes are most crucial to product quality and patient safety—makes it challenging to apply quality-by-design (QbD) methods and process analytic…
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
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 (Hospi…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This may be attributed to the complexities related to the use of cell lines, media formulation, and other bioprocessing steps that are prone to variability to varying degrees (4).
The inherent …
Article
Assessing Manufacturing Process Robustness
Stage 1, process design assessment, involves the following steps:
determining the quality target product profile and justification of critical quality attributes (CQAs) and critical…