As a US-based cleanroom design and build operation, Germfree is closely monitoring the trade decisions of the US, as well as the pharmaceutical regulatory updates in the EU that establish global standards.
The company’s Chief Strategy Officer, Carol Houts, plays a key role in decision-making on these matters and shared some insightful thoughts when she spoke with Cleanroom Technology.
Keeping up with executive orders
Houts explains that there are three main impacts from executive orders that Germfree are looking to keep on top of. “It's a matter of how do we harness these priorities that the administration has put out, and how do we build solutions around it,” she says.
The first is the push for domestic production, which is creating a need for increased infrastructure capacity in the US, which does not currently exist.
Addressing the need for rapid increased capacity is Germfree’s “sweet spot”
Houts explains that the company’s business model is already set up to be a solution to this, calling it their “sweet spot”. Germfree is a provider of mobile and modular cleanroom solutions, and the team has already been providing increased capacity for drug shortages on short notice.
Houts talks about a recent example of this when the team provided mobile units with On Demand Pharma (ODP), specifically for a hospital called North Mississippi Medical Center. She explains that the ODP project enabled them to develop some technology to pilot a model that will directly help with the needs created by the anchoring push.
The second key impact is in a similar vein and surrounds the Strategic National Stockpile modernisation, which Trump put in motion in his first term with an executive order.
Houts explains that in instances where a singular or very few companies are almost entirely responsible for an essential product, it is very easy for a small problem to cause widespread issues. Such as the hurricane in 2024 that took out IV solutions in the country, where 40% of all hospitals were purchasing from Baxter. Again, this is where being able to provide rapid response surge capacity is important.
We don't know what kind of funding is going to come to support these mandates
Finally, there has been a push to diversify the drug supply chain for APIs and biologics in case of another global event like the pandemic.