Search results for " stability"
Article
Alkaline stability of Fc and VH3 binding in protein A resins
In the development of antibody purification protocols, you need to know your Ab molecule and its possible affinity binding sites for the chromatography resins. In this study, we have looked at…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… development—can be subject to genetic alteration that may potentially impact the integrity and/or stability of those transgenes and, in turn, impact drug substance production. Provided is a comprehe…
Article
Modeling the Degradation of mAb Therapeutics
Kinetic modeling can be an effective tool for establishing product stability, offering a deeper understanding of these processes and allowing developers to mitigate the risk of product degradation dur…
Article
Tackling Analytical Method Development for ADCs
The influence of conjugation on antibody binding must also be evaluated, and a wide range of stability studies must be conducted. Fortunately, both improvements in analytical technology and increased …
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Live viral vaccines may also be challenged with stability issues and require frozen temperatures to remain viable and potent.
Similarly, a viral vector-based vaccine can cause an …
Article
Manufacturers Struggle with Breakthrough Drug Development
Consequently, FDA officials urge manufacturers with a newly designated breakthrough to meet early with CMC reviewers to discuss strategies for ensuring product quality, including development of stabil…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Concerns related to their stability are also discussed.
Applications of VLPs
The well-defined structure of VLPs, stability, non-infectious nature, and their ability to encapsulate molecules ha…
Article
Fusion Proteins Pose Manufacturability Challenges
The TNFR provides specificity and the Fc segment increases the stability.
In fact, the most successful fusion proteins to date have been so-called Fc fusion proteins, according to Carter. “These f…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
What’s New in Upstream Technologies
Single-use sensor and adapter
Emerson’s Rosemount 550pH sensor and Rosemount 550DW dissolved oxygen (DO) sensor adapter provide improved sensor stability for single-use bioreactors and are suited …