The bottom line for single-use bioprocess equipment is, simply, the bottom line: cost savings from reduced time, material, and energy usage related to cleaning and cleaning validation, rapid ramp-up of production campaigns, and more flexible, comprehensive utilization of facilities and equipment.
Numerous authors, many not affiliated with single-use vendors, have confirmed the cost-effectiveness of disposable bioprocessing. Estimates on labor savings vary from a low of 3% to a high of 50% and everything in between.
Pushback from customers tends to occur at the early stages of adoption. End-users believed, for example, that GE’s pre-packed columns (part of ReadyToProcess) were not as cost-effective as single-use or single-campaign equipment. Every advance in single-use processing was met with similar skepticism.
Every process and situation is different. GE Healthcare uses a process economics calculator—actually an Excel spreadsheet—to determine if single-use is the correct strategy based on approximately 20 factors related to the process, frequency, time, type of alternative equipment, and others.
For example at small scale for a “typical” disposable flask-based culture, GE’s Wave bioreactor™ reportedly reduces cost per run by about $400, or $7,000 per year. Savings for stirred-tank vs. Wave are similar, but with the added intangible benefits of eliminating cross-contamination (which, in fact, may also be valuated economically).
It is for high-cost operations like chromatography that the calculations get really interesting. Despite roughly equivalent equipment costs per cycle, the ReadyToProcess column saved about 15 hours of labor in packing, testing, and cleaning, 30 hours in cleaning and cleaning validation per cycle, said Attridge.
According to GE, ReadyToProcess columns are targeted to customers, particularly CMOs, that generate pilot batches, toxicology runs, and small clinical batches.