Search results for " degradation"
Article
Viral Clearance Challenges in Bioprocessing
…sting lab, potentially leading to changes in the process intermediates due to aggregation or product degradation, which can result in different performance for individual unit operations compared to …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…
Article
Evaluating Design Margin, Edge of Failure and Process
46-49
A product’s or process’ design space is generally considered to be the area where process parameters safely (without failure or high amounts of degradation) can be processed and achieve al…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
…lar weight, the presence of aggregates or higher molecular weight (MW) species, and the formation of degradation products, such as protein clips, and impurities. Today, SEC is predominantly used to m…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
But with continuous processing, once the protein is secreted from the cells it can be taken out of the bioreactor and purified immediately, so there’s no degradation.
Up until a few years ag…
Article
Design of Experiments for Analytical Method Development and Validation
Stability of the reference is a key consideration and accounting for degradation when replacing standards is critical.
Identify all Steps in the Analytical Method
Lay out the flow or sequence …
Article
Essentials in Establishing and Using Design Space
Design space is generally considered to be the areas where the product or process parameters can be run safely (without failure or high amounts of degradation) and achieve all critical quality attribu…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
Such increases could change the characteristics of the cell culture broth, leading to higher levels of product-related heterogeneous proteins (aggregates, degradation products, processing variants) an…