Viral Clearance

Updating Viral Clearance for New Biologic Modalities

December 02, 2020

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

Single-Use Mixing Technology for Virus Clearance (Part 2: Compatibility, Leachables, and Scale-Up Studies)

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.

Validating Virus Clearance in a Single-Use System Part 1: Film Adsorption and Virus Inactivation Studies

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.

Assessing Viral Inactivation for Continuous Processing

September 28, 2018

Testing demonstrates an automated semi-continuous process strategy for viral inactivation with steps that mimic batch processing.

Ensuring Viral Safety of Viral Vaccines and Vectors

September 01, 2018

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

Purolite Launches New Protein A Resin

June 28, 2018

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Putting Viral Clearance Capabilities to the Test

May 01, 2018

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

Control Viral Contaminants with Effective Testing

October 01, 2017

Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.

Development of Purification for Challenging Fc-Fusion Proteins

October 01, 2017

This study outlines methods for an alternative protein-polishing process for challenging proteins.

Affinity Chromatography Accelerates Viral Vector Purification for Gene Therapies

September 15, 2017

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.