OR WAIT 15 SECS
December 02, 2020
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
November 01, 2018
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
October 01, 2018
This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
September 28, 2018
Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.
September 01, 2018
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
June 28, 2018
The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.
May 01, 2018
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
October 01, 2017
Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.
This study outlines methods for an alternative protein-polishing process for challenging proteins.
September 15, 2017
A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.