Supplier dependency is a potential pitfall for drug companies, according to researchers who say a strategic approach to bioprocess technology sourcing is vital. Competition in the single-use technology sector is fierce. To gain an edge, suppliers try to differentiate their platforms using, for example, bespoke operating systems or by designing them to only work with specific reagents they also supply.

While this creates choice, it can be a challenge, according to Diego Schmidhalter, PhD, from the Technical University of Western Switzerland, who says, “Suppliers seek to develop a unique selling proposition and differentiation, while users welcome standardization. The large number of different designs prevents the development of second supply options, which is an issue that became apparent during the COVID-19 pandemic and explains why many drug firms impacted by suppliers temporarily halted production.”

Competition

In addition, tech sector competition impacts prices in a variety of ways, Schmidhalter says, adding, “The development of multiple solutions serving the same purpose with low purchase volume, rather than a few standard designs ordered at large quantity, drives cost.”

For other types of technology, choice is more limited, and sales volumes are higher. However, here the lack of competition also increases prices, Schmidhalter says.

“A few suppliers dominate the market for specific equipment solutions such as bioreactors, chromatography systems, or tangential flow filtration skids up to the 2000 L scale. There is a lack of competition.”

And there are other reasons why drug companies that use single-use systems can become overly reliant on suppliers.

“Some single-use equipment comes with specific consumables which cannot be purchased elsewhere,” Schmidhalter says, adding “even a lack of simple single-use assemblies, can put manufacturing at risk in times of supply shortage.

“In addition, sometimes users maneuver themselves into a lock-in situation, by requesting extra customization of equipment, which may demand customized single-use assemblies to be used on the equipment.”

To try and reduce the risk of supplier dependency, Schmidhalter and colleagues outlined what they describe as a strategic approach to the management of single-use technology in a research paper published in October.

“The suggested strategy focuses on standardization of equipment, standardization of single-use assemblies by definition of standard components, and design rules for consumables,” they point out. “We also recommend the introduction of a common approach for the qualification of single-use assemblies within a company and the development and companywide introduction of tools, which provide global oversight on consumables in use within a network.”