Search results for "scale-up"
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 notebooks…
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
Scale-up, scale-down, and process transfer
The transfer of biopharmaceutical production processes to clinical and commercial scales is challenging. The developmental work leading to an optimized p…
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…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
“When scaling up, it can sometimes be challenging to apply the correct scale-up strategy to get reproductive and scalable results, whatever the platform chosen. This difficulty can lead to a lower tit…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Such low doses require smaller facilities, which can be equipped with single-use (SU) technology, resulting in a faster scale-up and facility implementation.” Similarly, viral vaccines can be produced…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Scale-up/scale-out:Stability studies and cryopreservation/biopreservation methods optimization, logistics worked out.
Manufacturing change validation/product comparability studies:Necessary t…
Poster
Scalable Continuous Chromatography Process for Enhanced Efficiency in Biomanufacturing
…iva, we use two case studies to demonstrate that PCC is a robust and scalable technology: a 50-fold scale-up of a three-column PCC (3C PCC) mAb capture step within the lab-scale ÄKTA™ pcc system…