Search results for " scale-down"
Article
Viral Clearance Challenges in Bioprocessing
For scale-down tests to provide reliable viral clearance data, the actual challenge feed must be representative of that in the full-scale process. Achieving this goal can be difficult, because the tes…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
A comprehensive case study of the application of QbD principles to the development of a mAb product (A-mAb) has recently been published that describes extensive use of scale-down models to gain proces…
Article
Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…
Article
Using Digital Twins to Model Process Chromatography
The fundamental principle of in silico scale-up and scale-down of chromatography is that only the fluid dynamics outside the pore system change. Once a molecule enters the pore system, its behavior fo…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The wide availability of scale-down models for suspension processes, such as the ambr platform from Sartorius, also allow for process intensification to increase vector productivity to comparable leve…
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
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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
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…
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
Poster
Scaling In-Line Buffer Preparation from Process Development to Manufacturing
Preparing buffers for large-scale chromatography requires significant resources: time, money, and storage space. Inline conditioning (IC) is one possible way to address these challenges. At the same t…