OR WAIT null SECS
December 02, 2022
The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
January 28, 2022
Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.
April 02, 2021
A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
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.