Advanced single-use technologies (SUTs) in bioprocessing are not being adopted as quickly as expected, largely because of poor vendor data and the heavy validation burden placed on end users. This was made apparent during April’s Bioprocess Online Live event on closing the adoption gap for advanced SUT.
At this online Live event, nearly 62% of attendees said adoption gets stuck due to insufficient vendor data or the difficulty of validating single-use systems. Industry experts explained that companies are interested in newer SUTs, but the time, cost, and complexity of qualification studies create major barriers.
Survey results showed strong demand for improved SUTs, especially in the cell and gene therapy (CGT) sector, where manufacturers often rely on lab-grade materials i with limited vendor documentation instead of full-on GMP, commercial-manufacturing-grade materials. Many companies are willing to replace existing systems if the transition can be done smoothly and safely.
Confidence in vendor-provided extractables and leachables data remains limited. While most users are somewhat confident in the data, many still need to conduct their own studies, which can cost $30,000–$40,000 and delay projects by months.
Experts also emphasized that the problem is not only the amount of data vendors provide, but also how usable it is. Data often arrives as PDFs that are difficult to automate or integrate into internal systems, increasing the risk of errors during data conversion.
The panel concluded that vendors can help accelerate adoption by providing complete, accessible, and machine-readable data in simple formats such as tables. Better communication and easier access to reliable information would reduce validation work and make companies more willing to adopt advanced SUTs.
Read the complete article:
https://www.bioprocessonline.com/doc/insufficient-vendor-data-is-hamstringing-single-use-adoption-0001