Search results for " protein characterization" in Articles / App Notes

Article Detecting Protein Aggregates and Evaluating their Immunogenicity
New technologies for protein characterization tell us more about particle classification, as opposed to simply providing particle counts. Regulatory agencies are increasingly asking drug manufacturers…

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Host-Cell Protein Measurement and Control
Jun 01, 2015 By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem BioPharm International Volume 28, Issue 6, pg 32–38 Host-cell proteins (HCPs) constitute a major part of proce…

Article Analyzing Proteins Using SEC, MALS, and UHPLC
…atography (UHPLC)-based SEC are overcoming many of the limitations of SEC and enabling more detailed protein characterization. SEC and aggregation SEC is most commonly used to characterize pr…

Article Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis. By Michiel E. Ultee, PhD, Dr. Richard Easton This article reviews the implications of cell-culture co…

Article Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics Kinetic models can be used to study aggregation and fragmentation to help ensure stability. By Anurag S. Rathore, Rohit Bansal …

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 Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must. Sep 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 27, Issue 9, pp. 32-35  Removal of protein a…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Virus-like Particles as Therapeutic Moieties of the Future
Reverse phase–high-performance liquid chromatography (RP–HPLC) is a frequently used analytical tool for protein characterization and purification, and has been recently shown to be useful for characte…

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