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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
The biopharmaceutical industry is increasingly turning to disposable, single-use systems that offer flexibility and cost benefits.
The biopharmaceutical industry is increasingly turning to disposable, single-use systems that offer flexibility and cost benefits. This trend was evident at the Interphex 2012 exhibit in New York earlier this month in the disposable systems and components that were prominent in many booths. Exhibitors commented that disposable systems were unheard of at Interphex as little as six years ago, but now they are everywhere.
Xcellerex, for example, displayed its FlexFactory system, which shrinks the cleanroom down around the equipment, as well as its single-use mixers and bioreactors, which included the 10-L laboratory-scale reactor and the large 2000-L reactor. Sartorius displayed its single-use equipment inside a demonstration-sized modular cleanroom from its partner, G-Con. Merck Millipore displayed its single-use technologies, which cover the entire process train. Roche Diagnostics recently implemented a Merck Millipore single-use assembly in a final filling suite, for example.
Wenzel Novak, director of pharma R&D at Groninger, and Matthew Vonesch, senior manager of manufacturing fill–finish at United Therapeutics, presented a case study on the use of presterilized, single-use disposable paths in sterile manufacturing. United Therapeutics began its pioneering project to use a disposable path in an isolator for sterile fill–finish in 2009. Vonesch noted that, at the time, there was a lack of knowledge in how to manufacture and validate this and there was no history of regulatory approvals. United Therapeutics worked closely with suppliers to customize technology, and today its process has not only received regulatory approval but their facility is being used by FDA as an example in training sessions. He encouraged companies to not be afraid to try disposables although he noted that they are not designed for every process.
Vonesch noted reduced set-up time, reduced costs, and flexibility as advantages of the disposable path. He echoed a presentation made at Interphex by Engin Ayturk, a scientist from Pall, who presented a case study detailing the process and economic benefits of single-use technology using a disposable flow path and bags in tangential flow filtration (TFF). Ayturk pointed out that single-use TFF reduced cost of goods and capital cost, with dramatically less water usage compared to multiuse technology. The cost savings were greater for smaller numbers of batches per year and smaller batch sizes although with high volumes, multiuse technology can be lower cost than single use.
The displays and presentations point to continued growth of single-use technology. One supplier commented that the technology is now successfully tested, and says that the industry is ready to embrace disposables for big, global projects.