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Application note

Application note: Tipping point – what is driving the adoption of rFC for bacterial endotoxin testing?

As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.

Over the last 20 years, the worldwide value of traded pharmaceutical goods has grown six‑fold, from $113 billion in 2000 to $629 billion in 2019. Yet amid such robust growth comes risk to supply chain security as manufacturers become increasingly dependent on a global network of suppliers. In a recent McKinsey Global Institute survey, nearly 50 percent of respondents cited sole sourcing of inputs as a critical vulnerability – and 25 percent pointed to a lack of visibility of supplier risks.

One of the most common strategies for building resilience is to expand the network of suppliers for critical components or raw materials. As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions, which in some cases puts industry one step ahead of regulators. Such is the case with alternative methods for bacterial endotoxin testing (BET), which involves the development of recombinant reagents like Recombinant Factor C (rFC). With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.