Search results for " scale-up" in Articles / App Notes
Article
Chromatography Scale-Up: Don’t Get Tied Down by Bed Height
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When scaling, you can make better use of existing chromatography columns while avoiding overcapacity.
Keeping a constant residence time is a well-est…
Article
Scaling Up Novel Therapies
Chromatography and filter manufacturers have developed scalable and reproducible low-volume mimics of their industrial-scale equipment, which allow more accurate scale-up work than ever before, he say…
Article
New Therapies Present Scaling Challenges
For a gene therapy, some aspects of its manufacturing process can use a scale-up strategy similar to a mAb, but other aspects of its manufacture cannot be easily be scaled up.
The cell therapy ch…
Article
Being Thorough When Transferring Technology
[In regards to microbial processes], a typical example of a scale-up issue would be a process that has to be transferred that was already produced in a smaller scale. However, we sometimes face the si…
Article
Process Chromatography Selection for Downstream Processing Applications
Some factors companies may consider when selecting a separation technology include the stability of the biologic, buffer compatibility, and ease of scale-up. In this roundtable discussion, industry ex…
Article
Technology Innovations Improve Process Chromatography Performance
… including the stability of the biologic, compatibility of the buffers used, and the ease with which scale-up can be achieved. Recent developments in process chromatography have addressed challenges …
Article
Use of Multivariate Data Analysis in Bioprocessing
While loading plots and variable importance plot (VIP), plots were used for assessing scale-up and comparability of the cell-culture process, batch-control charts aided in fault diagnosis during routi…
Article
Understanding Validation and Technical Transfer, Part 3
… applications (INDs) and biologics license applications (BLAs), and ultimately commercial production scale-up.
Initially, development information can be kept in research or laboratory notebook…
Article
Unifying Continuous Biomanufacturing Operations
In the future, manufacturers will still have to identify optimal cycle time; weigh the risk of scale-up and explore how to construct continuous models that could eliminate scale-up altogether; test th…
Article
Generating a Fully Processed Antibody
In this article, the authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct funct…