Numerous industries have demonstrated that continuous manufacturing provides significant benefits and advantages, ranging from reduced capital and operating expenses to greater efficiency and product quality and consistency. The conventional approach to biopharmaceutical manufacturing involves the batch performance of a series of unit operations separated by hold steps requiring additional tanks and/or biocontainers. Such an approach fails to maximize facility use, requires large buffer volumes, and results in overall inefficiencies.
An integrated, continuous approach to bioprocessing connects each unit operation, minimizing the need for intermediate hold steps. As a result, the overall process is more efficient, has a smaller physical and environmental footprint (favorable process mass intensity, PMI, values and environmental factors), requires less initial capital investment, and has lower overall operating costs. The longer operating periods (weeks or months compared with hours to a day or two) also mean that smaller equipment can provide larger quantities of product. In addition, the increased automation involved in continuous operations results in greater process control, more consistent product quality, minimal downtime, and minimization of human intervention, reducing the likelihood of nonconformance and increasing operator safety.
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