Magali Barbaroux, Author at BioProcess InternationalBioProcess International

The Green Imperative: Part 3 — Postuse Management of Single-Use Bioprocessing Materials, Today and Tomorrow

by William Whitford, Sade Mokuolu, Magali Barbaroux, Mitchell Snyder, Mark Petrich, Megan Baillie, Brian Horowski and Don Young

The world desires a more sustainable economy in which resources can be saved, products can be profitably used, and at the end of their useful life, component materials can be recycled into other useful products. The bioprocessing industry has made efforts to meet those goals and has learned a great deal about the role of plastic components in sustainable manufacturing. The most important lesson might be that a science-based approach is required to provide an accurate benchmark of manufacturingʼs environmental…

The Green Imperative: Part Two — Engineering for Sustainability in Single-Use Technologies

by Magali Barbaroux, Brian Horowski, Sade Mokuolu, Mark A. Petrich, Mitchell Snyder, William G. Whitford and with the BPSA Sustainability Committee

In BPI’s June 2020 issue, the first installment of this series introduces the study and implementation of single-use (SU) technology to provide a more sustainable manufacturing environment (1). We presented evidence showing that the economic and social benefits of SU systems currently outweigh the residual environmental risks. Not only is SU technology often a better environmental choice than traditional biomanufacturing options, it also is sometimes the only choice for rapid process design and facility start-up. In situations such as the…

The Green Imperative: Part One — Life-Cycle Assessment and Sustainability for Single-Use Technologies in the Biopharmaceutical Industry

by Magali Barbaroux, Brian Horowski, Sade Mokuolu, Mark A. Petrich, William Whitford and with the BPSA Sustainability Subcomittee and Bill Flanagan

Much has changed since large-scale single-use biomanufacturing equipment was introduced some 15 years ago. Since then, these materials have become accepted and established in production and downstream bioprocessing. Concerns about the environmental impact of single-use (SU) biomanufacturing equipment have become more prevalent as our environmental awareness has increased and related concerns have become more urgent (1). For example, many recommendations and even laws have emerged regarding plastic convenience packaging and products (2, 3). People have become more sophisticated in appreciating…

Embedded Particles in Single-Use Bags: Risk to Bag Integrity and Drug Product Purity, or Only a Cosmetic Defect?

by Klaus Wormuth, Lucy Delaunay, Veronique Gissinger, Nelly Montenay and Magali Barbaroux

When using single-use systems (SUS) to process biopharmaceuticals, preventing drug product contamination from extractables and leachables (E&Ls) and embedded particulate matter (gel particles) in the polymer films used to make bioprocess bags is critical. Using a pressure burst test to assess film integrity, Sartorius Stedim Biotech’s Klaus Wormuth and colleagues compared Flexboy and Flexsafe samples with gel-particle-free materials to assess their potential for contamination. The results showed that only large (2–4 mm2) gel particles affected the burst test results, concluding…

Visible Particulate Matter in Single-Use Bags: From Measurement to Prevention

by Klaus Wormuth, Melanie Gauthier, Mathieu Labedan, Veronique Cantin, Fanny Gaston, Manon Thaust, Nelly Montenay and Magali Barbaroux

Parenteral pharmaceuticals must be “essentially free” from visible particulate matter (1). In the production of biopharmaceuticals with single-use systems (SUS), biocompatibility requires controlling interactions between drug substances/products and SUS surfaces to ensure drug product quality and patient safety with regard to extractables/leachables and particulate matter. Any particulate matter stuck to fluid-contacting surfaces of process components could wash off and contaminate process fluids. Depending on system configuration, a final drug product could be at risk for particulate matter from SUS. Risk…

Consistently Superior Cell Growth: Achieved with New Polyethylene Film Formulation

by Christel Fenge, Elke Jurkiewicz, Ute Husemann, Thorsten Adams, Lucy Delaunay, Gerhard Greller and Magali Barbaroux

During the past decade, single-use bioprocessing bags and bioreactors have gained a significant foothold in the biopharmaceutical industry because they offer a number of advantages over traditional stainless steel equipment, especially for clinical production, multiproduct facilities, and emerging economies. At the same time, some companies are concerned that plastic materials might release potentially toxic substances that could affect cell growth and product titers (1). In a worst-case scenario, they could even compromise drug safety when a company uses disposable bags…

Robust and Convenient Single-Use Processing: The Superior Strength and Flexibility of Flexsafe Bags

by Elisabeth Vachette, Christel Fenge, Jean-Marc Cappia, Lucy Delaunay, Gerhard Greller and Magali Barbaroux

With the increased use of disposable bioprocessing bags in all critical process steps of the biopharmaceutical drug production, there is a growing requirement for high-quality, robust, and easy-to-handle bioprocessing bags. The new generation of films and bags must combine multiple mechanical, physical, and chemical properties to make these products suitable and scalable for all processing steps in upstream, downstream, and final filling operations, including cell culture in rocking motion and/or stirred-tank, single-use bioreactors as well as storage, mixing, shipping, and…

Enhanced Assurance of Supply for Single-Use Bags: Based on Material Science, Quality By Design, and Partnership with Suppliers

by Jean-Marc Cappia, Elisabeth Vachette, Carole Langlois, Magali Barbaroux and Heiko Hackel

Growing adoption of single-use bags in commercial production of biopharmaceutical drugs raises new challenges for bag suppliers and drives the need for consistent product quality, improved assurance of supply, robust change management, and business continuity planning. In close collaboration with resin and film suppliers, polymer scientists and biologists at Sartorius Stedim Biotech have followed a stringent material science and quality by design (QbD) program to develop a completely new polyethylene film and to achieve consistent performance of new Flexsafe bags…

Covering the whole development process for the global biotechnology industry

Author Archives: Magali Barbaroux