INTERPHEX 2025: Industry Initiates Interchangeable Single-Use Assembly Components in Response to COVID-19 Supply-Chain Disruption

During the COVID-19 pandemic, supply-chain disruptions led to extended lead times, sometimes exceeding a year, which significantly impacts biopharmaceutical manufacturing and patient access to therapies, says Nicole Hunter, head of Global WMArchitect at Watson-Marlow Fluid Technology Solutions (WMFTS). Hunter spoke with the PharmTech Group at INTERPHEX 2025, which occurred April 1–3 in New York City.

“We really saw in COVID this really exacerbated example of demand exceeding supply. What we saw was lead times going up for assemblies to sometimes [more than] 52 weeks, which is [a] really, really long time and obviously very disruptive for the biopharma company and getting the therapy to patient[s]. So, one of the reasons for that was that one component would be validated in an assembly, and that meant if that component was difficult to get hold of—because the demand was really, really high—you couldn't supply the whole assembly,” Hunter says. “So, what would be better is if you could have that component or another one built in, where the other component may be more freely available, and then you can minimize the time to deliver the whole assembly and minimize the impact to patients.”

As Hunter notes, the dependence on specific validated components in assemblies was a key issue. This dependence caused bottlenecks when those components became scarce due to high demand. To address this challenge, the bio/pharmaceutical industry began an initiative and introduced the concept of interchangeable parts. This approach allows for substituting validated components with equivalent alternatives that meet the same specifications in terms of fit, form, and function, Hunter explains.

By pre-agreeing on the equivalency between suppliers and manufacturers, the process remains compliant, maintains quality, and minimizes disruptions to production workflows. This initiative enhances supply chain resilience by reducing dependency on single-source components and improving assembly efficiency, Hunter emphasizes. She points out that industry professionals are discussing advancements in this field and looks forward to the collaborations and innovations that will be fostered at INTERPHEX to optimize bio/pharmaceutical manufacturing processes.

Hunter gave a talk at INTERPHEX 2025 on “Futureproofing Single-use in Bioprocessing.”

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About the speaker

Nicole Hunter, PhD, Head, Global WMArchitect, Watson-Marlow Fluid Technology Solutions

Nicole Hunter, PhD, is the head of WMArchitect single-use solutions at Watson-Marlow Fluid Technology Solutions (WMFTS). Prior to joining WMFTS, she held the position of R&D manager at Thermo Fisher Scientific leading a team of chemists and microbiologists developing in-vitro diagnostic devices. Her PhD in the area of pharmaceutical materials science was undertaken at the University of East Anglia, United Kingdom. Hunter also has pharmaceutical industry experience gained from working in the drug discovery department of Pfizer Animal Health. She is an active member of several industry working groups and committees including BioPhorum, the Bio-Process Systems Alliance, the International Organization for Standardization, and the British Standards Institution.