A Detail View of Single-Use Equipment Opportunities

The authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.
Mar 01, 2010
Volume 2010 Supplement, Issue 1

Figure 1: Single-use cell culture system. (ALL FIGURES ARE COURTESY OF THE AUTHORS)
Patent expirations, stiff competition, plant utilization, product safety, and supply assurance are some of the challenges facing the biopharmaceutical industry. The manufacturing landscape has changed dramatically during the past several years—and it's still evolving.

Novel approaches for treating specific diseases such as cancer are very promising. However, the days of biotechnology innovations being measured purely on gaining blockuster status (i.e., reaching more than $1 billion in revenues) are largely gone. The capacity constraints predicted in the late 1990s, combined with insufficient development pipelines and tougher regulations, caused a major market consolidation, evidenced by acquisitions, alliances, and outsourcing.

Similar to what the semiconductor industry already experienced, drug manufacturers face a changing environment that requires innovation and efficiency. They must manufacture products economically and efficiently while also improving quality and safety. Understanding cost drivers within the manufacturing and development processes is key to assessing the impact of new business models and technologies.

The costs associated with constructing and operating manufacturing capacities as applied to clinical phases and large-scale manufacturing call for challenging current paradigms. Single-use technologies represent one option to achieve operational excellence without compromising quality.

Single-use technologies are being used more in biopharmaceutical manufacturing and that use is expected to increase substantially in the coming years. With the further penetration of disposables into larger volumes and more critical areas of the biomanufacturing process, however, companies involved in biopharmaceutical development and the production of new molecules must closely examine the advantages, limitations, and facility implications of single-use manufacturing scenarios.

The challenge is to design and implement application-specific, integrated-process solutions that follow the same principles as conventional process designs regarding quality, engineering, automation, and control. Single-use technologies are not an "one-size-fits-all" solution. They must be intelligently integrated into process designs.

Figure 2: Single-use unit operation.
Process analytical technologies (PAT) and quality by design (QbD) are major initiatives in the industry that will influence the future technology penetration significantly. It's important to examine additional improvement opportunities offered by the increased implementation of single-use solutions to exploit advantages. Production facilities, traditionally, were built to house stainless steel-based production scenarios. Does this mean that new facilities are required to be built the same way? What about cleanroom classifications to operate individual process units? Single-use solutions are presterilized, closed systems that can reduce, if not eliminate the need for extensive cleaning and steaming utilities. Aseptic-processing requirements that benefit from single-use solutions through the reduction of cross-contamination successfully support the shift to multipurpose manufacturing designs and concepts. One might think that disposing such solutions adversely affects carbon-footprint evaluation. However, there is no standardized approach to such calculations and studies published in the past two years demonstrate that the opposite is true. The authors contend that understanding the advantages provided by single-use technologies, mitigating the limitations, and exploring new opportunities is the most-appropriate approach for operational excellence.

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