Monday, June 27, 2016 Daily Archives

Optimizing Continuous Monoclonal Antibody Polishing By Using Coupled Unit Operations

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The biopharmaceutical industry is under a great deal of pressure to modernize manufacturing to meet the challenges of production at vastly different scales for niche drugs as well as for expected massive blockbusters, biosimilars, and regional manufacturing. To address these challenges, the biopharmaceutical industry is embracing process intensification through single-use and continuous processing technologies. Implementing these technologies offers increased productivity and manufacturing flexibility and reduces the footprint, capital outlay, and operating costs. Pall Life Sciences has developed several technologies designed…

June 27, 2016
Center of Excellence

Enabling Continuous Processing Using a Step-by-Step Approach

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Mario Philips is Vice President and General Manager of Single-Use Technologies at Pall Life Sciences. In February, he spoke with BPI publisher Brian Caine and editor in chief Anne Montgomery about Pall’s commitment to enabling continuous processing and its development of single-use technologies. In that discussion, he addressed some major process bottlenecks and Pall’s solution to them, including centrifuge replacements by continuous acoustic wave separation, continuous chromatography with multicolumn chromatography technology platform, and a simplified version of tangential-flow filtration. Read…

June 27, 2016

A Look At Perfusion: The Upstream Continuous Process

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Although implementation of continuous manufacturing for biopharmaceuticals is in the early stages, continuous cell culture technology has been around for close to thirty years. Perfusion was initially developed in the late 1980s as a means for increasing protein titers (1). However, high costs driven by media consumption limited widespread commercial adoption. In the same time frame, advances in cell line engineering, media composition, and bioreactor design led to 10-fold increases in titers for batch and fed-batch modes, eliminating the first…

June 27, 2016

Flexible Automation for Continuous Unit Operations

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Continuous processing has the potential to provide significant cost and time savings for biopharmaceutical manufacturing, but that potential can be realized only if appropriate automation solutions are available for continuous flow between disparate upstream and downstream operations. Pall Life Sciences’ Allegro MVP system, a fully automated bioprocessing system designed for use in upstream and downstream single-use processing, enables flexible automation and thus facilitates continuous biopharmaceutical manufacturing. This article presents the results obtained using the Allegro MVP system in combination with…

June 27, 2016