Search results for " optimization"
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
…fers are made to specification?”
Also popular in 2018 was an article covering the optimization of fed‑batch culture conditions, which describes a broadly applicable and efficient workflow fo…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Poster
Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development
This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein. The optimization work was conducted by…
Article
Downstream Processing for Cell-Based Therapies
For example, several studies have investigated the optimization of cell-expansion processes of adherent human cells. Significant progress has been made in recent years with human mesenchymal stem cell…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
The application of mechanistic models for process development and optimization has been a topic of discussion in the pharmaceutical industry for many years. Mechanistic models are considered as an a…
Article
Improving PAT for Biologics
…liable single-use sensors that enable the application of PAT as a basis for effective automation and optimization, according to Becker. “In addition to established multi-use offline sensor technologi…
Article
High-Throughput Process Development in an Historical Environment
Traditionally, optimization of the refolding steps has been considered a bottleneck during downstream process development. In the presented work, instead an automated platform using 96-well plates for…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
In the example, the data from the six experiments are used as the input for in silico optimization experiments. The result is a resolution map and optimized chromatogram within which the optimum condi…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…