White Paper | March 20, 2008
Evolving Toward Single-Use Bioprocessing: From Solutions To Holistic Value Creation
Source: Sartorius Stedim BiotechWhite Paper: Evolving Toward Single-Use Bioprocessing: From Solutions To Holistic Value Creation
As the biopharmaceutical industry continues to evolve and mature, the challenges facing it change as well. Among many other pressures, bioprocessors are increasingly pressured to shorten drug development timelines, reduce costs, diversify product pipelines, and implement risk-based strategies, not to mention maintaining continued focus on patient safety and regulatory compliance.
As industry needs have changed, bioprocessing technologies have advanced in parallel. No trend better exemplifies this symbiotic evolution than the shift to disposable, single-use technologies. Disposable solutions continue to help bioprocessors accomplish their goals. The myriad benefits related to capital investment, cleaning (labor, downtime, utilities, and validation), space and storage considerations, and cross-contamination elimination are widely understood and represented in the literature by now.
Until recently, disposable technology typically meant replacing stainless steel filter housings with single-use capsules, stainless steel vessels with bags, and hard piping with flexible tubing. Other components, however, upstream and downstream of disposable solutions, often remained reusable. Intermittent use of disposables provided only intermittent solutions or benefits. This hybrid bioprocessing prevents synergistic value realization.
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