Search results for " scale-up" in Articles / App Notes
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…
Article
Platform Approach Speeds Process Development
The implementation of disposable systems with diverse scales creates additional challenges in scale-up and scale-down because more systems and scales have to fit together with respect to process perfo…
Article
Lessons Learned Accelerate Vaccine Development
This achievement was made possible through the simultaneous refurbishment of an existing production facility and the technology transfer, optimization, and scale-up of the bioprocess combined with tre…