Search results for " scale up model"
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAbs at Large Scale
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As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quic…
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Mechanistic Modeling: Theory to Implementation
Is your downstream process development workflow relying on experimental data alone, or are you leveraging mechanistic modeling? Gain a better understanding of effective modeling implementation to deve…
Article
A Small-Scale Model to Increase Yield in Cell Culture Perfusion of mAb at Large Scale
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As process intensification is adopted into large-scale manufacturing, the responsibility on scale-down models to accurately represent the expanded operating space quick…
Article
Scale-Up Model of a mAb Process from Microbioreactor to XDR-1000
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In process development, it is desirable to test process parameters in small scale and later scale up the process into larger production scale. A theoretical scale-up study was per…
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
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Discovering the unknown: How does in silico process development change PD scientists’ work?
In silico process development for chromatography is a paradigm-shifting approach that redefines the routine work of process development scientists. But what does it actually mean to perfor…