Search results for " charged 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
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
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
By Anurag Rathore, Vijesh Kumar
Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…
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
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
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 primary objective of this step is to remove host-cell proteins, DNA, charged variants, and aggregates. Bind and elute mode is used to facilitate removal of product-related impurities.
• A …