Downstream Processing

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.

Articles

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

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

Putting Viral Clearance Capabilities to the Test

Richard Adair is virologyÂ and technical support manager,Â SGS Life Sciences, Glasgow, Scotland.

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

Control Viral Contaminants with Effective Testing

Yun (Kenneth) Kang is director of Process Development at Patheon Biologics.

Jay Jicao Kang is director of Analytical Development at Patheon Biologics.

Richard Ding is principal scientist at Patheon Biologics

Guodong Chen is a senior scientist at Patheon Biologics.

Evan Shave is associate director, Technology Transfer, at Patheon Biologics.

Ijeoma Cynthia Ikechukwu is a senior scientist at Patheon Biologics.

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

Development of Purification for Challenging Fc-Fusion Proteins

Orjana Terova is global product manager for POROS chromatography products, Bioproduction at Thermo Fisher Scientific (Bedford MA, USA).

Pim Hermans is Director of Ligand Discovery, Bioproduction at Thermo Fisher Scientific (Leiden, The Netherlands).

Stephen Soltys is Senior Field Application Scientist for POROS and CaptureSelect chromatography products, Bioproduction at Thermo Fisher Scientific (NC, USA).

Frank Detmers is Director of Ligand Applications, Bioproduction at Thermo Fisher Scientific (Leiden, The Netherlands)

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

Affinity Chromatography Accelerates Viral Vector Purification for Gene Therapies

Mostafa Eissa is quality compliance section head at HI KMA PharmaâEgypt

Protecting against microbiological contaminationover the whole manufacturing process grows increasingly important.