Finding Value in Single-use Systems

Single-use systems offer clear benefits to biopharmaceutical manufacturing that include increased flexibility, reduced contamination, and time and cost savings. “A few years back, the value of single-use versus reusable was far from clear to end-users, but, in almost every case, those days are behind us now. A wealth of cost comparison data published by end-users, vendors, and industry organizations have demonstrated that, in the vast majority of situations, the single-use approach is more cost-effective,” says Richard Bhella, product manager at ATMI LifeSciences.

Cost analysis software programs can be useful in quantifying cost savings for particular applications and specific process conditions. Case studies using a cost-analysis program (BioSolve, Biopharm Services) found significant cost savings, particularly in reduced water use (1, 2). The Parenteral Drug Association will be publishing a technical report this fall that gives a primer on the economic factors of implementing single-use systems.

Single-use systems have been finding commercial use in new capacity, new applications, or developmental–scale applications. In green-field sites, where the facility is being built from the ground up without the burden of previous process equipment decisions, the value of single-use-lower capital investment, faster startup and greater process flexibility-is clear, says Bhella. It is more difficult, however, to justify replacing existing commercial stainless-steel capacity.

Applications where single-use is seen as taking hold include routine mixing, such as buffer and media preparation, and liquid and powder storage/handling. “In these applications, the time saved simply from not having to clean the stainless-steel mixers is a huge throughput multiplier,” notes Bhella. Bioreactor applications have been slower to grow, probably due to excess capacity with existing equipment. One emerging single-use bioreactor segment is cell therapy, in which single-use technology makes manufacturing small batches of personalized medicines feasible, says Bhella.

Hybrid systems that combine multi-use, stainless-steel product-contact sections with disposable product-contact sections are often used. Hybrid systems reduce capital investment and move costs from fixed, up-front costs to activity-based costs (i.e., consumables) that are spent at the time of manufacture, notes Andrew Sinclair, president of BioPharm Services, in an analysis of hybrid systems in a monoclonal antibody manufacturing case (3).

In

Pharmaceutical Technology's

annual reader survey of biopharmaceutical manufacturers, 66% of respondents in both 2011 and 2012 reported that they use hybrid systems (4).Use of completely disposable systems is slowly rising however, with 12% of respondents in 2012 compared to 8% in 2011 saying that they used all-disposable systems.

References

1. A. Sinclair and M. Monge, BioPharm Intl., 34 (12), 22–27 (2010).
2. E. Ayturk, presentation at Interphex (New York City, 2012).
3. A. Sinclair and M. Monge, BioProcess International, 9 (9), 12–17 (2011).
4. A. Ritter, “Bioprocessing & Sterile Mfg.” supplement to Pharm. Technol.36 (5), s6–s10 (2012).

To read the recent blog, “Single-use Systems Proliferate”, go to PharmTech Talk.