The widespread adoption of integrated continuous bioprocessing in biologics manufacturing is the next frontier for the biopharmaceutical industry. The key to its success, however, is the availability of novel upstream and downstream technologies that will not only reduce facility footprint, capital expenses and product cost of goods (CoGs), but also will increase process productivity, flexibility and further facilitate the utilization of single-use and/or disposable technologies.<br/>In this context, the suite of cutting-edge technologies we have evaluated to enable cost effective and reliable implementation of continuous bioprocessing of biological drugs, included the Cadence™ Inline Concentrators within the single-pass TFF (SPTFF) platform, the BioSMB® multicolumn continuous chromatography platform, and acoustic wave separation (AWS), a disruptive cell culture clarification technology,  among many others.<br/>By utilizing a 20L CHO fed-batch cell culture bioreactor with cell density range of 25x10^6 – 30x10^6 cells/mL and 65 to 90% cell viability, multiple in-house feasibility runs were conducted through a novel integrated continuous bioprocessing train of unit operations.<br/>Coupled with the process economics modeling, this presentation will provide a risk-based and data-driven overview of an integrated continuous bioprocessing platform and highlight its subsequent requirements, challenges and opportunities for product development, process control, monitoring and automation.

PD scale realization of an integrated continuous bioprocessing platform

251st National Meeting (2016)

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