Search results for " design"
Article
Assessing Manufacturing Process Robustness
The assessment focuses on analyzing the information and knowledge gained from the three stages of the process validation lifecycle: process design, process performance qualification, and continued pro…
Article
Improving Upstream Predictability
Today, better understanding of cells and how they interact with their environment has enabled improvements in most aspects of upstream processing, from bioreactor design and media development to proce…
Article
Advances in Engineering of Protein-Based APIs
“Protein therapeutics traditionally were designed as single receptor/protein antagonists or agonists. But to effectively combat disease, many future drugs will require multiple proteins being agonized…
Article
Implementing QbD in Sterile Manufacturing
Equipment Design and Operation
BioPharm: How is equipment design and operation modified when implementing QbD in sterile and aseptic manufacturing?
Weikmann: Looking first at equipme…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx.
Early biotechnology products in th…
Article
Modeling Bioreactor Performance
Challener
Bioreactor design, including the geometry of the tank and impeller and the locations of inlets, has a direct impact on the performance of cell-culture and fermentation processes. Modelin…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
“Traditional laboratory-scale systems, such as roller bottles or cell factories designed for use with adherent cells, are generally used for small-scale production of viral vectors, while fixed-bed cu…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The requirement for greater oxygen transfer in high-density cultures and minimal shear stress on delicate cells pose technical challenges for single-use bioreactor design, and vendors are responding w…
Article
Using Single-Use Technologies in Downstream Processing
Systems can be designed, tested (with good scale-down models), and implemented fairly quickly without the need for procuring stainless-steel parts or developing related cleaning cycles.
Challenges…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Countries around the world, most recently Japan, have passed regulations designed to speed development of these treatments, which are now a big and growing global business.
In 2013, according to t…