Downstream Processing

Tareq Jaber, tareq.jaber@crl.com, is associate director at Charles River Laboratories.

Anja Tessarz, Anja.Tessarz@crl.com, is associate director RGDB, SME Viral Clearance at Charles River Laboratories.

Articles

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Viral Clearance Studies: Challenges and Beyond

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.

Texcell North America Builds New Laboratory Facility

Sherri Dolan is a global technology consultant for Virus Clearance at Sartorius North America.

Paul Nolan is a process scientist at Sartorius in Glasgow, Scotland.

Stephen Carey is an analyst at Sartorius in Glasgow, Scotland.

Craig Quinney is a process scientist at Sartorius in Glasgow, Scotland.

Lorna Littlejohn, lorna.littlejohn@sartorius.com, is the manager of Confidence Virus Clearance Services at Sartorius in Glasgow, Scotland.

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.

Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses

Feliza Mirasol is the science editor for 

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

Updating Viral Clearance for New Biologic Modalities

Dr. FranÃ§ois Coutard was bioengineering unit manager at the Bioengineering unit, LFB Biomanufacturing.

Dr. Nick Hutchinson was technical content marketing manager at Sartorius Stedim Biotech.

Eve DePauw is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

Ronan McCarthy is senior downstream process scientist at the Bioengineering unit, LFB Biomanufacturing.

Ludovic Bouchez is downstream process technician at the Bioengineering unit, LFB Biomanufacturing.

Dr. Isabelle Uettwiller is head of validation lab, Confidence Validation Service at Sartorius Stedim Biotech.

AmÃ©lie Boulais is process development consultant, Integrated Solutions Marketing at Sartorius Stedim Biotech.

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.

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

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

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

Mark Schofield, PhD, is senior R&D manager, Pall Life Sciences.

Kyle Jones is R&D applications scientist II at Pall Biotech.

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

Assessing Viral Inactivation for Continuous Processing

Martin Wisher, PHD, is senior director, global head of regulatory affairs for BioReliance at MilliporeSigma.

Anissa Boumlic, PHD, is associate director EMEA vaccine and viral therapies, MilliporeSigma.

Damon Asher, PHD, is associate director Americas vaccine and viral therapies, MilliporeSigma.

Priyabrata Pattnaik, PHD, is head of biologics operations-Asia Pacific, MilliporeSigma.

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

Ensuring Viral Safety of Viral Vaccines and Vectors

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

Purolite Launches New Protein A Resin

Rita C. Peters is the former editorial director of 

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