Disposable Biopharmaceutical Processes–Myth or Reality?

Nov 02, 2006

Biopharmaceutical processes typically require a significant investment in equipment—often a substantial obstacle for start-up companies. The risk of drug development failure is often high, further limiting access to the required capital. Flexibility and lower capital outlays are required not only by start-up companies, but also by research organizations with multiple product lines and by companies requiring quick capacity increases. Disposable technologies offer the highest potential for these companies to meet their business requirements. With lower capital requirements and increased flexibility, disposables are an important part of these companies' risk management strategy.

Development of single-use components is revolutionizing the approach to biopharmaceutical drug development and manufacturing. Disposables provide more solutions each year.

The Business Environment

Bioprocessing has historically been extremely capital intensive and fixed-cost driven, requiring dozens of separate unit operations, each typically involving many pieces of equipment. To minimize the risk of cross-contamination, equipment is often dedicated to a single drug product, even when the facility manufactures multiple products.

Capital investments exceeding $1 billion are not uncommon for cGMP biomanufacturing facilities.1 Substantial capital requirements are a common barrier to entry for start-ups, smaller companies, private firms, and research organizations. Often, smaller companies that have discovered a promising drug must rely on other companies that have already invested in manufacturing plants, equipment, and competency. Arrangements include mergers and acquisitions, subcontracting arrangements to CROs or CMOs, and licensing arrangements. The number of companies that focus on drug discovery far exceeds the number of those capable of manufacturing commercial biologics, partly because of the enormous capital investment required for manufacture.

Biotechnology companies are also burdened with massive business risk, in part due to unknowns related to clinical results, cost-cutting trends in healthcare, and long lead times in marketing approval. To mitigate market risk, many companies strategically diversify their development pipeline, an approach that requires additional flexibility of equipment. Demand for the drug, and therefore capacity requirements, must also be scrutinized; the target population size may fluctuate and additional indications for the same drug may be approved later. Lastly, competitive forces are ever-increasing, including the threat of biogenerics, making time-to-market a critical success factor for most drugs.

In response to these trends and risks, biomanufacturers value solutions that reduce capital requirements, increase production flexibility, reduce risk, and increase speed to market.

Impact on Capital Investment

The value of disposable technologies continues to become more widely accepted, as they are integrated into increasingly more manufacturing processes. While disposables impact operating costs, for existing and new processes, this article focuses on the impact to new processes and the associated capital investment.

Figure 1. Support container for disposable storage bag (source: TC Tech)
Stainless steel components for mixing, storage, and transportation require substantial space, whether they are in use or not, whereas single-use containers are a more efficient use of space during their useful lifetime. Inventory storage requirements are negligible, compared with stainless steel, requiring comparable space only during use. Whether full or empty, flexible containers are typically stacked with the aid of support structures (Figure 1), which themselves are collapsible when not is use. After use, single-use bags are discarded, not stored.

As capital investments, the number of stainless steel vessels at a facility remains fixed. Bags are "just-in-time" consumables, existing only at the plant when needed. At any given time in a manufacturing facility, more steel vessels are typically sitting idle (or in some stage of cleaning) than are actually being used for processing.

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