Enabling pandemic speed to clinic for SARS-CoV2 neutralizing antibodies

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Improved Titer in Late-Stage Mammalian Cell Culture Manufacturing by Re-Cloning

Improving productivity to reduce the cost of biologics manufacturing and ensure that therapeutics can reach more patients remains a major challenge faced by the biopharmaceutical industry. Chinese hamster ovary (CHO) cell lines are commonly prepared for biomanufacturing by single cell cloning post-transfection and recovery, followed by lead clone screening, generation of a research cell bank (RCB), cell culture process development, and manufacturing of a master cell bank (MCB) to be used in early phase clinical manufacturing. In this study, it was found that an additional round of cloning and clone selection from an established monoclonal RCB or MCB (i.e., re-cloning) significantly improved titer for multiple late phase monoclonal antibody upstream processes. Quality attributes remained comparable between the processes using the parental clones and the re-clones. For two CHO cells expressing different antibodies, the re-clone performance was successfully scaled up at 500-L or at 2000-L bioreactor scales, demonstrating for the first time that the re-clone is suitable for late phase and commercial manufacturing processes for improvement of titer while maintaining comparable product quality to the early phase process

What Does Rhetorical Theory Do? And Is That A Stupid Question?

This article reports on the 2002 National Communication pre-conference seminar. As part of the continuing dialogue among rhetoricians about the current state of rhetorical theory, the pre-conference seminar series offered an opportunity for rhetoric scholars to consider the functions served by rhetorical theory. The seminar opened with framing comments from co-leaders, followed by brief presentations from four featured speakers. These were followed by small group sessions in which participants explored the themes developed in their position papers