Search results for " CQA"
Article
Downstream Processing for Cell-Based Therapies
For anchorage-dependent cells, dissociation into single-cell suspension, while retaining the CQAs, is essential. Current available DSP platforms generally offer either high specificity or high through…
Article
Mapping a Route for Cell and Gene Therapy Process Development
… documented evidence that the scaled process can consistently produce the final product, meeting the CQAs based on the specified critical process parameters and critical material attributes. To achie…
Article
Moving PAT from Concept to Reality
“This complexity makes it hard to identify and understand the factors influencing the product CQAs. Hence, these processes benefit from a stricter control strategy, where high levels of automation and…
Article
Digitalization: The Route to Biopharma 4.0
For chromatography, relating data from sensor with the CQAs of the process has been shown to improve CQA predictions with errors less than 5% (9). In two-column capture chromatography, dynamic control…
Article
QbD Improves Cell-Culture Process Control
QbD starts by defining the relevant target product profile and CQAs.
Subsequently, development of the manufacturing process takes into account the likely impact that process parameters will hav…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…sp;
4:57 - Cell perfusion
7:16 - Critical process parameters and CQA
9:25 - PAT
10:35 - Continuous manufacturing
Transcrip…
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
…d B2 have statistically significant impact on cell proliferation, and hence these were identified as CQAs. Third, it was demonstrated that lots of mAb differing in terms of relative levels of each va…
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 (…
Article
N-Glycan Analysis of Biotherapeutic Proteins
…uch, when ADCC constitutes the mechanism of action, the presence of high-mannose-type N-glycans is a CQA.
As shown in Figure 1B, there are non-human or immunoreactive N-glycan structures th…