OR WAIT null SECS
June 01, 2017
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.
April 01, 2017
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
February 01, 2017
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) using a small-scale model.
January 01, 2017
This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.
November 01, 2016
The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.
Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.
September 01, 2016
Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.
August 01, 2016
Multiple methods are required for detecting and removing protein impurities.
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.