Search results for " charge variants" in Articles / App Notes
Article
Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Traditional practice for assessing impact of charge variants on product safety and efficacy involves either use of fractions that contain a mixture of individual variants or use of individual variants…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Figure 3: Modeling of separation of charge variants following ion-exchange process chromatography. The graph in (A) shows the reconstruction of a peak from high-performance liquid chromatography analy…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
Article
QbD and PAT in Upstream and Downstream Processing
Size variants or charge variants, for example, may be generated during hold times, and product quality attributes such as host-cell proteins and size variants are typically reduced through the purific…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
…ic products as well as their critical quality attributes (CQAs) including glycosylation, sialyation, charge variants, and aggregation among others (1). Optimal growth of cells requires monitoring and…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…