Search results for "cell-culture"
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
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
However, adhesion degree is not the only factor to be considered when choosing the most convenient cell detaching method within a given cell-culture process. The authors consider different factors and…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The cell-culture process and media are known to have a significant effect on the expression and stability of therapeutic products as well as their critical quality attributes (CQAs) including glycosyl…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
PCVs entered vaccine processes via porcine trypsin, a common cell-culture reagent. In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Cell-culture applications are impossible without the use of nutrient media for cell multiplication and subsequent product generation. Although several serum-free and chemically defined nutrient media …
Article
Use of Multivariate Data Analysis in Bioprocessing
MVDA applications in cell-culture operations
Cell-culture operations are by far the most common platform used for production of protein therapeutics. In this endeavor, various advanced offline and…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Examples include cell-culture, synthetic DNA, chimeric antigen, and recombinant protein nanoparticle vaccine technologies.
Egg-vaccine technology limitations
Traditional vaccine manufactu…
Article
Challenges in Cell Harvesting Prompt Enhancements
Cell harvesting involves the separation of the cell-culture from the medium and running it through several techniques: centrifugation, microfiltration, depth filtration, and filtration through absolut…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
They are also designed to increase cell-culture density while maintaining adequate gas exchange and supply of nutrients and preventing accumulation of cell culture byproducts, according to Tan.
Fo…