Search results for " design" in Articles / App Notes
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…
Article
Viral Clearance Challenges in Bioprocessing
“Current filters can be used in this application, but they were not designed to run under continuous and high throughput conditions like those required for media supply,” he observes. Filter vendors a…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Reimagining Affordable Biosimilars
With new configurations and solid-state designs, SPR has become a workhorse in protein and nucleic acid applications. The sensor surfaces have been modified to allow cell-based binding to mimic real-t…