Search results for " small-scale"
Article
Ensuring Sterility in Small-Scale Production
I am a small-scale parenteral manufacturer and have been approached to support a clinical program through Phases II and III. What considerations are important for the small-scale production lots?
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Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAbs at Large Scale
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We have developed a reliable small-scale model for a monoclonal antibody (mAb) perfusion process using TPP® TubeSpin® Bioreactor tubes and the ReadyToProcess WAVE 25 R…
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAb at Large Scale
Perfusion continues to be one such operating mode which lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach.
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAbs at Large Scale
Perfusion continues to be one such operating mode that lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach.
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAb at Large Scale
Perfusion continues to be one such operating mode that lends itself to adding benefit at the manufacturing scale while adding complexity to the small-scale approach.
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
…ggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model. The temperature-time profiles of manufacturing-scale samples under different fr…
Article
Evaluating E&L Studies for Single-Use Systems
• Reproduce a small-scale assembly of the manufacturing process, which includes the most at risk materials (based on preliminary risk assessment).
These approaches have been applied in three…
Article
Platform Approach Speeds Process Development
For comprehensive process development, initial work packages are media screening and optimization, which are typically performed in automated high-throughput, small-scale cultivation systems. The impa…
Article
Modeling Bioreactor Performance
It is important to be certain that the small-scale model used to determine the design space and the operating ranges of critical process parameters provides predictive results comparable to the produc…
Article
Robust Optimization, Simulation, and Effective Design Space
Verify the small-scale and at-scale results. Rescale the small-scale model to match the at scale process.
12. Define the effective design space used for process control and define the purpose of t…