Cost Advantages of Single-Use Technologies - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Cost Advantages of Single-Use Technologies
Single-use technologies can help simplify equipment and facility design, thus bringing cost advantages. But how are these cost advantages realized and what criteria can be used to assess their impact? This article is part of a special issue on Bioprocessing and Sterile Manufacturing.


Pharmaceutical Technology
Volume 34, pp. s26-s31

This article is part of PharmTech's supplement "Bioprocessing and Sterile Manufacturing 2010."

The biopharmaceutical and vaccine industries are embracing single-use technologies more and more as alternatives to fixed stainless-steel equipment. Although the technologies still have limitations of mass and heat transfer, the generally mild process conditions in biopharmaceutical operations are conducive to using a disposable plastic film surface as the product-contact layer. Disposable components also eliminate the need for surface cleaning to avoid contamination and cross-contamination.

Several factors enable the disposable plastic bags used for solution preparation, storage, and product-generation steps to promise potential cost advantages. Because single-use systems can provide sufficient volume (i.e., currently 2000–3000 L, depending on the application) to accommodate the capacity requirements of most commercially produced vaccine and biopharmaceutical products (including those whose quantities have been raised by yield increases from new cell lines), the use of disposables is posed to grow in the next decade.

As any biopharmaceutical-industry professional will probably testify, no two projects are alike. It can therefore be difficult to make general estimates about potential cost advantages. However, when making early estimates regarding technology concepts, it is practical and acceptable to put some rough criteria to use.

NNE Pharmaplan (Soborg, Denmark) uses a modular approach to designing and engineering processes and production facilities. The company breaks down the project's scope into modules for structured engineering activities. Process modules are typically combinations of process equipment (e.g., one bioreactor with three associated feed tanks) so that they can be seen as the main building blocks of the production process.

This modular approach allows an overview of the factors that affect a project, and process modules also can be the basis for the calculations that obtain cost-related criteria for the application of single-use technologies. Although experience has shown that these quick estimates can be remarkably accurate, this approach is clearly rough and should only be seen as an estimate.

Investment costs

Investment costs are probably the biggest and most obvious source of the cost advantages of single-use components over fixed, steel systems. The difference arises mainly because single-use systems require less instrumentation and fewer utilities. Because sterilization and cleaning processes are eliminated, installation and support systems are reduced.

This advantage clearly allows a manufacturer to purchase more capacity for a limited startup budget, but also has an effect on the variable costs because a much lower investment sum has to be amortized, compared with that of fixed steel systems. In fact, it is the low up-front investment cost, which lowers variables costs, that typically tips the scales in favor of single-use systems.


Figure 1
As seen in Figure 1, NNE Pharmaplan calculated the projected investment cost savings that single-use process modules would provide, compared with 100% stainless steel equipment, for an upstream biopharmaceutical operation (1). Figure 1 shows that investment cost savings of about 30% can be expected with single-use technologies, depending on the extent of their use, compared with a full stainless steel setup. The 30% point is actually an overestimation because microbial fermentation and centrifugation were included in these considerations, although single-use technologies are not readily available for these applications. Recent developments such as single-use microbial fermentors from Xcellerex and single-use centrifuges from CARRCentritech are starting to push these boundaries, however.

Area impact

Single-use systems have fewer utility requirements, and they also can be stacked or moved in certain volume ranges. These systems thus occupy a small footprint because of their improved designs and mobility, as well as their decreased demand for piping, valves, instrumentation, and the related maintenance space required. To be sure, single-use systems do require room for manipulation, transport, and waste removal, but even with these space requirements, they occupy less space than do fixed systems. To manipulate or maintain the equipment—which already occupies less space—it is possible to push the equipment aside to allow access. In this way, the process modules can share each other's footprints to a certain degree.


Figure 2
NNE Pharmaplan calculated the reduction in equipment footprint that could be achieved if single-use systems were installed as process modules instead of 100% stainless steel for the same upstream area (1). Figure 2 shows that it is possible to save about 25% of the space that a similar stainless steel installation takes, based on the extent to which single-use technology is employed. These reductions can come from flexibility for future applications or investment-cost savings that result from smaller building costs. Typical cleanroom cost ratios range from $3000 to $5000 per square meter. Therefore, single-use equipment also can lower buildings' fixed costs when used in cleanroom areas.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here