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.