Search results for " scale-up"
Article
Trends in Downstream Bioprocessing
…e developers harboring regulatory concerns that hold them back from using newer solutions or process scale-up.
Chromatography column issues are showing a trend for decreasing “significant” or “se…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
During scale-up, we noted that effective filtration required a much larger membrane area than was feasible, so we introduced a continuous flow centrifugation process, followed by depth filtration to m…
Article
The Lifecycle Change of Process Validation and Analytical Testing
…ds will not only support a robust commercial manufacturing process but can also reduce the burden of scale-up and technology transfer, thereby supporting product-divestment initiatives. The implement…
Article
Register to the Chromatography + Filtration Virtual Summit 2024
Explore the latest advancements in process development and scale-up
5-7 March, 2024 - 15:00 - 18:00 CET all 3 days
Join Cytiva Chromatography and filtration summit online to lear…
Article
Digitalization: The Route to Biopharma 4.0
Scientific knowledge comprises process development and validation, whereas technical know-how involves process definition and scale-up for commercial production. Multiple organizations need to collabo…
Article
Using Digital Twins to Model Process Chromatography
…cs, considering the small operating window at manufacturing scale and prohibitive expense of testing scale-up conditions. Models are typically calibrated using lab-scale data for material and cost ef…
Article
Cell-free Expression Systems Pose Cell Culture Alternative
But for clinical, the scale-up production is still under development. As early as 2011, J.F. Zawada et al. have successfully scaled up Escherichia coli (E. coli) cell-free expression of cytokines to 1…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
…ovides a rapid solution for industrialization, frequently limiting process development risks, robust scale-up strategies, and the ability to produce industrial quantities using single-use technologie…
Article
Cell-Culture Advances Test Bioreactor Performance Models
Traditional, reliable method
Typically, bench-top bioreactors are operated in the performance design space of larger bioreactors to model scale-up performance, according to Parrish M. Galliher, …
Article
Moving PAT from Concept to Reality
Furthermore, asserts Grieb, a well-characterized and monitored process together with scalable hardware can significantly reduce the cost and efforts of process scale-up and scale-down. Overall, theref…