By Ken Clapp, Upstream Product Manager, GE Healthcare
Although keeping a better-faster-cheaper mindset, the bioprocessing industry cannot sacrifice quality. Over the past few decades, tremendous improvements have been made, including the industrialization of Chinese hamster ovary (CHO) cells and biologics titers.
Less than 20 years ago, single-use bioreactors were not part of our biomanufacturing vernacular. Such systems have become synonymous with offering improved product quality, faster turnaround times, and cost-effective operations. Single-use bioreactors continue to find new processes in product development and manufacturing worldwide. The convergence of this technology, the higher titers, and better product specificity fostered an environment to reassess the conventional ways of biologics manufacturing.
Better, faster, cheaper is relentless. Terms like extreme density and process intensification, have entered our lexicon. The conceptual objective is clear: greater productivity. Upstream productivity is not limited only to growing more cells, making more end-product, or obtaining a purer product. Productivity in upstream processes may be any combination of these that can be practically implemented.
Operating bioreactors in perfusion mode has proven to be an effective intensification method. Practical implementation, however, is essential to realizing the benefits. The single-use bioreactor must be flexible enough to integrate with various perfusion devices and associated feed and harvest streams, spanning everything from aseptic connectors and tubing to process control and data management. Bioreactors must have the capability to support high cell concentrations with proper mixing, oxygenation, and removal of metabolic waste products such as CO2. Higher gas flows require effective exhaust gas management, using condensers and multiple heated filters.
Productivity must be assessed across the entire process, with consideration of all inputs, outputs, and interactions. Manufacturers and suppliers must work together to achieve this worthy objective. The quest for new methods and technologies to achieve greater productivity never ends. Whether it is operational methods or technologies, it comes down to thinking differently about established paradigms.
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