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A survey of issues in biomanufacturing research.

Article Excerpt
1. Introduction

Biological and healthcare applications will undoubtedly be one of the primary technology development areas of the 21st century. Today, scientists and doctors utilize new advances in biotechnology and biomedical engineering to treat diseases, extend human body functions and make better healthcare devices.

Biomanufacturing concerns products that are typically expensive, complex and complex and focused on improving, or even providing, life for the members of our society. The technology is changing rapidly. New products are being launched where the underlying technology did not even exist 5 years ago. Many of these products are heavily regulated by government agencies such as the Food and Drug Administration (FDA), because of the link to human life. Once these products are designed, their manufacture is a complex and challenging process.

Biomanufacturing can be defined as the design, development, implementation and management of systems for the production of products that are integrated into human systems.

Many of the existing technologies in manufacturing initially seem to be applicable to biomanufacturing. For example, biomedical products still require production scheduling. Machining is evident in products such as pacemakers. The relationships become less clear on further consideration. For example, what is needed in biomanufacturing when we begin to produce synthetic skin? Or, when a company develops a new organism and wants to produce it for sale, what new production processes are required and what approval procedures are needed to ensure that it is safe? What new quality control systems are required? How is the production of the various product subsystems best integrated for production of the final product?

These new products and industries present problems that need answers and represent an opportunity for research. An investigation of the differences between biomedical manufacturing and traditional manufacturing is required along with the articulation of any new research requirements to support the manufacture of products in these industries.

Biotechnology encompasses many different products, as shown in Fig. 1. The majority of the market is focused on Healthcare (69%). The term biotechnology is used in two general ways. Most often it refers to the technology associated with genetic engineering, as discussed by Grace (1997) or Joseph et al (1999), or bioterrorism, as discussed by O'Connel et al. (2004). The market survey above refers to all of the technology associated with biological applications, and thus encompasses genetic engineering applications as well as biomedical device technology. We use "biotechnology" in the broader sense throughout the paper.

Figure 1. Biotechnology market distribution. Plant Agriculture 13% Animal Agriculture 8% Chemical Food 5% Energy/Environ 1% Health Care 69% Other 4% Source: University of Oklahoma Biotechnology food chain Note: Table made from pie chart.

[FIGURE 1 OMITTED]

Figure 2 illustrates the food chain from biotechnology to biomedical manufacturing. Biomedical manufacturing requirements are generated from biomedical engineering, which designs the products to be manufactured. Those companies with good manufacturing development processes are effective at this task and are able to do it fairly quickly. This link, time to market, is becoming more and more important in the profitability picture of the typical company. Due to the heavily regulated nature of the relevant industries, the ability to develop manufacturing processes quickly after product approval by regulating agencies is imminent provides a significant competitive edge to these companies.

[FIGURE 2 OMITTED]

Healthcare systems create the requirements for products to be designed by biomedical engineering. There is obviously a great need for healthcare products. Many of the drivers and enablers include aging populations, advancements in technology, particularly in genetics, and the cost/power law in electronics. The process of manufacturing the products becomes critical as more products are provided and the time to market decreases in this industry, as it has in others.

Research in biotechnology also continues to spur growth of healthcare products. In the pharmaceutical industries, migration from a chemical process approach to a bioengineered approach is compressing the time to release a drug, and lowering the development costs.

Figure 3 (adopted from the Ernst and Young website, www.ey.com) illustrates the growth projections for the biotechnology market. This market was approximately $52 billion in 1995 and is expected to grow to $600 billion by the year 2015, representing a non-trivial segment of our economy.

Fig. 3. Biotechnology growth projections. 1995 52 1996 103 2015 (Projected) 600 Source: Ernst and Young Note: Table made from bar graph.

[FIGURE 3 OMITTED]

It makes sense to think about the manufacturing technology needed to support the production of the products to achieve the expected growth. In fact, the manufacturing infrastructure that will be needed to support this market is enormous. While the beginnings are in place in some segments, the capital expenses and development necessary to support a $600 billion per year market require a well-thought-out plan regarding research in technologies to support manufacturing in these industries. It would not be unusual for these industries to spend at least $600 billion in infrastructure development between now and 2015 to be able to produce $600 billion per year at that time.

Many of the technologies required to support the market for biomedical products do not exist today. Also, it is certain that many of the manufacturing technologies to support the market currently do not exist. The opportunity is ripe for universities to play a strong role in this technology and in its growth. They can support the development of technology in a partnership with industry.

Based on the research conducted in an exploratory study, the biomedical technology industries need a strong, well-articulated research agenda for biomanufacturing research that can be supported by...

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