What started off more than a decade ago as a cutting-edge technology has now become mainstream; the arguments in favor of biopharmaceutical production using single-use equipment have largely been proven. There is an understanding that financial considerations are no longer a deterrent for adopting disposables, but more importantly, there is another realization concerning the use of single-use technologies. The industry has started to look beyond the immediate manufacturing implications and into how these technologies benefit end users (i.e., patients) through increased product visibility, better product quality, and patient safety.
Patient safety is the most important topic of discussion in the biopharmaceutical industry today, and rightly so. Manufacturing companies are focused on finding ways to ensure that any accompanying risks are reduced to save patients from unnecessary risks to their health. Secondarily, manufacturers want to ensure that they are not losing batches because of contamination, which means lost money.
But what does all of this really mean? Here we look into how single-use technology continues to offer new levels of performance to the industry and how it can benefit the patient.DISCOVERING AN UNEXPECTED BENEFIT OF SINGLE-USE TECHNOLOGY
Although the economic model for using single-use technologies includes various benefits, the intangible benefit of increased patient safety has emerged and started a trend in the vast majority of multiproduct facilities. Many manufacturers are finding ways to implement single-use technologies into their process because patient safety, by way of avoiding cross-contamination, should trump cost savings.
While the adoption of single-use technology has made great strides, it is often true that a single-use-only facility may not meet all the needs of drug manufacturers, nor is it always feasible. Mixed needs, therefore, have spurred a trend towards multi-use hybrid or flexible facilities, which combine the proven benefits of traditional stainless-steel and glass equipment with the promise of single-use equipment. The key is finding the right balance to fully maximize the potential of the facility by reducing validations, water use, and operator risk, and increasing productivity. The most attention should be paid to how to introduce these flexible facilities in a way that greatly reduces (with the ultimate goal of eliminating) cross-contamination potential between successive product batches.
CROSS-CONTAMINATION CONCERNS INCREASE WITH POTENCY
The increasing potency of new medicines has further exacerbated the need to know what contamination risks are present. There are many new products that require only minuscule amounts of contaminants to cause a strong pharmacological reaction in patients. This potency is advantageous in dosing terms—maybe the dose will be one pill instead of three, or a biologic might need to be injected once a month rather than once a week. However, on the manufacturing side, it presents a new cause for concern. While a residual nanogram of aspirin may have no physiological effect, a microgram of a monoclonal antibody very well might have an effect that could be extremely harmful to the patient.
For a manufacturer reliant on fixed stainless-steel vessels, there is always a risk that minute quantities of product will be left behind to contaminate the next batch, regardless of how carefully a vessel is cleaned. As drugs become more potent, the safe limits for residual product carryover become ever more challenging to achieve. Single-use equipment eliminates the potential for cross-contamination almost completely, because the process vessels are thrown away after use.