Single-Use Technologies Reinforce Fluid-Handling Workflows (INTERPHEX 2024)

Speaking with Pharmaceutical Technology® at INTERPHEX 2024, Nicole Hunter, head of Global WMArchitect at Watson-Marlow Fluid Technology Solutions (WMFTS), discusses the importance of optimizing fluid-handling workflows in the bioprocessing space and the efficiencies that single-use technologies (SUTs) can offer for biomanufacturing.

“One of the main reasons to have really good workflows is to reduce the risk in your process,” Hunter explains. “You want to … safeguard your therapeutic during the process and expedite getting that drug product to the patient.” One way to achieve this is by ensuring a good robust supply chain, which means working with suppliers that have good global coverage and good capacity, she emphasizes. Ensuring that documentation of that supply chain is of good quality as well as confirming that the supplier(s) has compliance data and validation data in order are also critical, “so you can be confident that the manufacturing system that you're using is compatible with your process,” Hunter advises.

On SUTs, Hunter notes that one of the huge advantages that these technologies have brought to bioprocessing is flexibility and adaptability. “What [SUTs] have been able to do—in moving away from stainless steel systems—is to allow for quick changeover between drug products. One facility can make multiple drug products really easily; the manufacturing systems can be quickly assembled for the different drug products and changed out as, and when, needed. [SUT] also reduces risk of cross contamination because you're literally using that assembly for that drug product and then changing to another one.”

Hunter also notes that SUTS offer a “big financial benefit”, explaining that “the CAPEX [capital expenditures] requirements for a single-use technology are far lower than a stainless-steel system.” Thus, SUTs are a sensible option for facilities that are looking to have good flexibility and adaptability.

At the show, WMFTS showcased WMArchitect, a new range of flexible, single-use solutions for biopharmaceutical fluid management which aims to streamline biopharma processing, safeguard product, and reduce regulatory burden. The platform is suitable for high-purity biopharmaceutical process development, clinical trials, and small-to-large-scale production batches (1). “What we're looking to do, though, is to help our customers with their quality, compliance, and validation requirements,” Hunter says, expounding on the WMArchitect platform’s utility.

“In the industry at the moment, there are challenges around ensuring good quality data from suppliers, and, as part of our range, we've launched a validation testing service which allows us to … deliver the data to [customers] that they need to be able to be confident that they can safely use our product with their drug manufacturing process,” Hunter explains.

Another real challenge in the industry at the moment is ensuring that there is good compatibility between a given manufacturing system and the intended drug product, Hunter also observes. “Our product, along with others in the market, has an open architecture design, so we can easily change in or out components specifically to meet the drug manufacturing process needs,” she says. However, another challenge that still remains for the industry are lead times for these types of systems, although Hunter recognizes that lead times have improved in recent years. “Internally, we've done [much] work to increase capacity and improve efficiency in our workflows, so that we can get those solutions to customers as fast as we possibly can,” she adds.

Reference

1. Mirasol, F. WMFTS Showcases New Single-Use Solutions Designed to Optimize Fluid Management. PharmTech.com, April 16, 2024.