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. 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.
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. For products like APIs, which are mainly produced overseas, “around 80% of APIs are some of the numbers that are out there,” Houts recalls. Germfree provides fill-finish isolators for this exact purpose, so this is something the team needs to keep an eye on.
Houts has also seen some action on the domestic FDA inspection prioritisation mandate, which was recently announced. The mandate calls for regulatory relief and prioritisation for US companies and facilities contributing to domestic supply, whereas more frequent unannounced inspections on foreign companies. “We've heard from some companies that they were expecting inspections related to some of their applications to be fairly far out, and they are seeing those inspections becoming more rapid in timelines,” she says. Houts continues to say that she expects this will continue to evolve to at least the end of the year.
The last piece in this puzzle is the funding to support these mandates. “We don't know what kind of funding is going to come to support these mandates, so that's one of the tricky pieces. We just had some approvals, and so hopefully we start to see some budget allocated to these initiatives,” Houts says.
Expansion into stick-built
Expanding into new capabilities and applications is a big part of Germfree and Houts’ current plan.
Germfree acquired Arcoplast in October 2024. Arcoplast is a manufacturer of cleanroom wall and ceiling systems. Up until now, Germfree has focused on modular applications, essentially “turnkey boxes with cleanrooms or laboratories inside”. However, this new addition will allow the company to tackle stick-built projects with challenges around interior finishes and durability. "The beauty of [the Arcoplast product line] is that it holds up to BSL 3 and 4 lab requirements. It has to be really sealable.”
Houts reveals that the two companies are now fully integrated and, as a newly unified operation, the team has just delivered a modular BSL 4 facility in Asia that is now being installed.
Digitisation and automation of facilities
Along a similar timeline as the Arcoplast acquisition and expansion into stick-built applications, Houts has also been part of the launch of the new Smarthood for IV preparation. The CSO explains that this new solution integrates technology into biosafety cabinets (BSCs) or horizontal laminar flow units. The platform integrates primary engineering controls and technology by connecting all necessary hardware components with the pharmacy's software of choice.
Digitisation and automation of facility operations are one of the key highlights of the EU GMP Annex 1 document that guides sterile medicine production. Houts says that though the US FDA has not caught up on this yet, the world is looking at this as the blueprint for facilities going forward. She says this is especially important around isolator technology and design, and this fits well with the Smarthood launch.
Houts believes actually understanding the processes that companies are undertaking can and should guide the innovations that a company is developing. Houts thinks it is an application example of this is a upcoming project.
This new undertaking is an advanced biomanufacturing centre being built in partnership with King Faisal Specialist Hospital in Saudi Arabia. The facility will have 16 cleanroom suites, and Germfree’s involvement is not just limited to building them. Houts explains that the team is actually working to support the operational readiness side, which is the SOPs, the training, and the work instructions. She reveals that the team has brought on some key partners to help them. “We'll hope to make some announcements on that soon,” she says.
To try and make the SOPs, training and operation of this facility as smooth as possible, Houts explains that Germfree will be implementing a digital layer for how the facility operates. The aim is to give all operators a well-designed user interface that can guide their day-to-day work. Furthermore, the King Faisal team has given the mandate that this should be a paperless facility. “We're working really hard on how to bring all the digital automation, the digital tools available that are out there today, into this facility, so that there's a digital layer that really connects all the pieces,” she says.
The CSO reveals that Germfree are looking for industry collaborations on this and states that she hopes to make announcements on this in the coming months.
Final thoughts
The landscape of pharmaceutical production is a complex one, with the US playing a major role. Aiding supply chains and creating the most intuitive facilities possible are the drivers steering Houts and Germfree.
“We want to build smart facilities that support how facilities are actually operating. So we're working on it from the equipment side, as well as from the facilities side, and bringing all that together.”
Houts adds that the team is lucky to have a private equity owner that is 100% behind them and “sees the vision”.