Single-use technologies are becoming more widely accepted by biopharmaceutical manufacturers than ever before. The market is complex, fast-growing, and dynamic, which means integrated innovative technologies are the key to keeping pace with biopharmaceutical manufacturing needs. In fact, end users are already beginning to move away from singular disposable components to increasingly require suppliers to provide integrated solutions for specific process needs. So it is critical for suppliers to work closely with their customers and provide novel solutions.

Why the Switch?

Biopharmaceutical manufacturers are confronting the challenge of commercializing their new biological drugs faster and at lower cost than before. To meet those goals, many strive to develop more efficient processes. Single-use technologies present a sound solution.

Switching over to single-use technologies doesn’t require the “hard sell” that it used to because the benefits of such technologies have become evident. According to BioPlan Associates’ fifth annual survey (1), the top three most critical reasons for increased use of disposables include elimination of cleaning requirements, reduction of initial capital investments, and lowered risk of cross-contamination.

The driving reasons are different for biotherapeutic developers and contract manufacturing organizations (CMOs). The top factor for developers to switch to disposables is eliminating cleaning requirements, whereas the top concern for CMOs is minimizing cross contamination. CMOs often use disposables to lessen contamination risks among various projects. These companies are motivated by a need to get facilities or projects started quickly. Developers, on the other hand, tend to be more motivated by the need to keep maintenance costs low (2).

Challenges Remain: Although the benefits of single-use technologies are well understood, there are still challenges to overcome. The main reasons for not implementing these technologies include companies already having invested in other equipment, concerns over leachables and extractables from disposable components, and a lack of disposables on the market for specific requirements (1).

Those reasons are quite similar among both developers and CMOs — the major concern being leachables and extractables. Those associated with disposables are usually specific to each manufacturer’s project or system. The way a single-use system reacts and leaches undesirable components into solution can depend on variables such as pH, high protein concentrations, and the presence of caustics or metals (1).

Growth and Future Needs

The biopharmaceutical market in 2007 was ∼S106 billion of the global pharmaceutical market of S650 billion (2). Because most biopharmaceuticals are manufactured in small batches, advantages that favor disposables seem especially applicable to this market.

The average company’s investment in single-use technologies has increased over the past several years. The largest increases were in mixing systems (237%), dry media bags (66%), and bioreactors (43%) (3). Today, 38% of the S217,000,000 single-use market is for pilot/clinical scales and 35% is for commercial-scale production (3). That is expected to evolve into a S1,400,000,000 market over the next 10 years at 20% CAGR. Current market penetration is estimated at 9% and expected to increase to 17% by 2017 (3).

Biopharmaceutical companies expect suppliers to provide solutions that meet their specific process requirements as well as those that are user friendly. Integrated single-use technologies that allow for configurable integration and that include proven technologies, validation packages, and comprehensive technical support are necessary to drive the market forward.

For Example: Last month Millipore introduced Mobius FlexReady solutions at Interphex 2009. These systems were developed with a large degree of engineering and device integration analysis to help users install equipment, configure applications, and validate their processes quickly and easily. The systems combine single-use filters and assemblies with process-ready hardware platforms optimized for specific unit operations. These evolved from individual components to single-use assemblies to full-fledged solutions — and in the process became more efficient and cost effective for use.

Another example is the integration of process containers with connectors and filters. Lynx ST (steam to) and Lynx S2S (sterile-to-sterile) connectors are two enabling products that allow custom integration based on specific applications. Integrated solutions help end users work efficiently and potentially reduce their process times.

Over time biomanufacturers and CMOs are likely to integrate disposables into most or all of their processes (1). This trend will be dictated by economics, risk reduction, and speed. As new companies enter the industry and additional products move into the pipeline, the single-use technology option will become part of decision–making from the very start. This can help emerging organizations and those in less developed regions to be more effective and competitive than they might have been otherwise (1). Millipore is excited about the future for these technologies and prides itself in bringing innovation to the industry.

REFERENCES

1.) Langer, ES April 2008.Fifth Annual Report and Survey of Biopharmacuetical Manufacturing Capacity, BioPlan Associates, Inc., Rockville.

2.) 2008.Disposable Systems in Biopharmacuetical Manufacturing Fut. Pharmacuet. Q2.

3.) Worldwide Bioreactor Existing Capacity (2007–2010) data from JP Morgan, bioprocess technology consultant.