An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical Applications - Single-use TFF offers the greatest savings in clinical and contract manufacturing, where the scale is

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An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical Applications
Single-use TFF offers the greatest savings in clinical and contract manufacturing, where the scale is low and changeovers are frequent.


BioPharm International Supplements


Conclusions


Table 3. Cost of water, buffer, and clean-in-place solutions (for simplicity, the costs per liter of these solutions has been averaged)
Single-use tangential-flow filtration (TFF) cassettes offer significant improvements in process economics when compared to re-usable TFF cassettes. Presanitized cassettes are installed, equilibrated with buffer, and used in processing. There is no need to flush them with deionized water or water for injection, or to measure water permeability rates between runs, saving time and resources.


Table 4. Comparison of the overall costs in US dollars of reusable and single-use tangential-flow filtration (TFF), for a process requiring a membrane surface area of 2.5 m2 and assuming five batches per campaign
Thus, by eliminating several flushing and clean-in-place steps, single-use TFF reduces processing time and labor and overhead costs. Likewise, buffer and water consumption reduced by up to 75%.


Figure 4. The overall cost comparison between reusable and single-use tangential flow filtration, for a five-batch campaign with a membrane surface area of 2.5 m2
In addition to the economic advantages described here, development work and scale-up can be conducted much more quickly. Moreover, cassette performance is more consistent from run to run because each process uses a new membrane, and the risk of cross-contamination is minimized with single-use cassettes.

The economic benefits of single-use TFF are greatest in clinical manufacturing and contract manufacturing where the scale of operation is low (i.e., with a membrane surface area <2.5 m2) and frequency of process changeover is high (with ≤6 batches per campaign).

Removing non-value–added steps increases the efficiency and productivity of tangential flow filtration operations. This improvement in economics and productivity will benefit the entire downstream process.

In addition to the significant cost savings realized from the reduced labor, reduced buffer usage, and potentially reduced validation (although the latter is not accounted for in this model), the major benefit of single-use systems such as single-use TFF is an increase in productivity, which may amount to >45% in many cases.

Michael LaBreck is the global product manager for TangenX technology, and Mark Perreault is the director of membrane application development for TangenX technology, both at Novasep, 781.545.5756,


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