Search results for "CQA" in Articles / App Notes
Article
Downstream Processing for Cell-Based Therapies
As such, manufacturing processes need to be adapted to ensure that the cellular material retains its functionality and the critical quality attributes (CQAs) are maintained throughout the entire proce…
Article
Mapping a Route for Cell and Gene Therapy Process Development
…sed systems that can reach the target quantities while maintaining the critical quality attributes (CQA) of the final products are main challenges for allogeneic cell therapies, Baghbaderani agrees. …
Article
Moving PAT from Concept to Reality
“Not only are there many possible downstream unit operations, but also the critical quality attribute (CQA) most impacted by each step is diverse. The traditional methods for quality attribute measure…
Article
Digitalization: The Route to Biopharma 4.0
Researchers have attempted to create mechanistic models that can predict the impact of major process variables (5) on the critical quality attributes (CQAs) (6); however, these mechanistic models are …
Article
QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
Article
Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as protein size, homogeneity, presence of host cell proteins (HCP) etc.
In th…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Fifth and final, based on the risk assessment of these variants, aggregated and reduced GCSF samples were categorized as critical quality attributes (CQAs), while oxidized and f-Met GCSF samples were …
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
The experts examined possible mechanisms and technologies for improving methods and capabilities for measuring CQAs and for setting standards to help advance development of these promising therapies (…