Bio-pharmaceutical industries are facing issues of the inability to fund clinical trials, or produce enough life-dependent medicines that are in demand, thus, leading into a global drug shortage.
The shift towards Single-Use Technology (SUT) has become imperative for both clinical trials and for the solution to global drug shortages. Due to the time and cost efficiency of SUT, it has become more accepted to adopt and integrate complete single-use systems; however, the comfort and reliability associated with traditional stainless steel systems still looms over anti-progressive companies within the bio-pharmaceutical industries. However, with growing evidence of sterility and the U.S. Food and Drug Administration’s (FDA) open encouragement of switching to Single-Use Technology, also referred to as continuous manufacturing, or processing (“FDA Perspective on Continuous Manufacturing”), the doubts behind SUT is becoming minimized as there is little to no proof of harm with a transition towards a complete single-use system. Companies who have integrated and shifted towards a single-use system have typically expressed their satisfaction with Single-Use Technology, and the benefits of having this new technology versus a traditional stainless steel system, “Single-use disposable devices and systems have reduced overall contamination rates, enhanced production throughput efficiency resulting in decreased manufacturing operation and maintenance costs” (Trotter, “Adoption of Single-use Disposable Technology in Biopharma Industries – Manufacturing, Economic and Regulatory Issues to Consider”). Single-Use Systems spend less time with disassembly and clean-up of the system (as it does not require a disassembly, and the clean-up time is minimal), resulting in a quicker turnaround time for a new batch of medications. SUT allows for continuous manufacturing that a traditional stainless steel system doesn’t account for, which ultimately expedites the entire process of drug manufacturing, and can save companies weeks to months of time. In perspective, this can equate to hundreds, and even thousands, more product per bio-pharma company that switches over to a complete single-use system.
With the growing need for a rapidity in drug manufacturing, in order to supply larger batches of life-dependent medicines, or simply for a quicker processed clinical trial, Single-Use technology is the solution.
The future of bio-pharmaceutical processes, and manufacturing is the movement towards a completely single-use system, and Single-Use Technology. Be a part of the future.
ARTeSYN® Biosolutions can help with getting you there, as they manufacture and design a completely single-use system for bio-pharmaceutical companies.
Sources: Chatterjee, Sharmista, Ph.D. “FDA Perspective on Continuous Manufacturing.”U.S. Food and Drug Administration (2012): 2. Jan. 2012. Web [PDF]. 03 Oct. 2016.
Trotter, A. Mark. “Adoption of Single-use Disposable Technology in Biopharma Industries – Manufacturing, Economic and Regulatory Issues to Consider.”Home. American Pharmaceutical Review, 30 Mar. 2012. Web. 03 Oct. 2016.