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Adoption of rFC for Bacterial Endotoxin Testing

Originally published in European Pharmaceutical Review

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(1). 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(1).

One of the most common strategies for building resilience is to expand the network of suppliers for critical components or raw materials(1). 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.

Finding Common Ground for Sourcing

Both pharmaceutical companies and regulators have the same goal — ensuring continuous supply of safe drugs and therapies. Global pharmaceutical companies depend upon robust global supply chains to fulfil their endotoxin testing requirements to ensure patient safety. rFC is a safe, sustainable endotoxin testing solution that could mitigate many of the adverse trends impacting global supply chain consistency. However, the lack of compendial inclusion by the United States Pharmacopoeia (USP) continues to be a barrier to widespread  implementation.

While this limitation mostly affects pharmaceutical companies in the US, the impact is global. In fact, even European users who enjoy the compendial status of rFC face challenges if they want to export their products outside of the EU because gaining regulatory approval in non-EU countries requires them to validate rFC as an alternative method.

(1) Foster T, Patel P, Skiba K. Four ways pharma companies can make their supply chains more resilient. Pharmaceuticals & Medical Products Practice. McKinsey & Company. 2021.