Carol Houts takes the helm at Germfree at a moment when advanced therapies are forcing the pharmaceutical industry to rethink how, where, and how quickly medicines are made.

The company, which designs and manufactures modular cleanrooms, isolators, and specialized equipment for pharmaceutical and advanced therapy developers, has long positioned itself around speed, flexibility, and regulatory readiness. Houts describes Germfree’s role as helping customers “move from bench to patient” by giving them the controlled environments needed to stand up GMP manufacturing space faster and with less capital risk than traditional facility builds allow.

That proposition is becoming increasingly important as cell and gene therapies move from scientific promise into clinical and commercial reality. “In advanced therapies especially, where manufacturing processes are still evolving and speed to clinic matters enormously, that agility is a genuine competitive advantage for our customers,” Houts says.

But for Houts, appointed CEO after nearly a decade as Germfree’s Chief Commercial and Strategy Officer, the next phase is not only about innovation. “Germfree has built a strong reputation around disruptive innovation, and that will always be central to who we are,” she says. “But as I step into this role, the focus is on scale and a relentless commitment to delivering for our customers, our team, and the business.”

In this interview, Houts discusses the infrastructure gap facing advanced therapies, why modular manufacturing is becoming a risk-management strategy as much as a construction model, and what it will take to scale manufacturing capacity as the next generation of medicines moves closer to patients.

The science has genuinely outpaced the infrastructure. We’re seeing remarkable therapeutic innovation in cell and gene therapies that, theoretical a decade ago, are now in the clinic – but the manufacturing and facility side hasn’t kept pace. Companies are trying to scale processes that were designed for research, not production, and doing it under enormous time and cost pressure.

A few things stand out. First, speed to clinic is increasingly a competitive and commercial imperative, and traditional facility development timelines simply don’t fit. Second, manufacturing flexibility matters enormously when processes are still evolving, locking into fixed infrastructure too early is a real risk. Third, the talent and workforce required to build and operate these environments is genuinely scarce.

The regulatory environment adds another layer of complexity. Standards are evolving in real time, and developers are making major capital commitments without full visibility into where compliance requirements will land. That uncertainty makes flexibility not just operationally valuable – it’s a risk management strategy.

And internationally, the dynamic is fascinating. There’s significant investment in advanced therapy capability across the Middle East, Asia, and emerging markets – governments and health systems that want sovereign manufacturing capacity, not just access to imported therapies. The infrastructure challenge there is even more acute, because the ecosystem of contractors, tradespeople, and technical expertise that exists in the US and Europe simply doesn’t exist in the same way.

Modular and decentralized manufacturing have moved well past concept – we’re seeing real adoption, and the use cases are maturing. But I think it’s worth being precise about where these approaches create the most value, because “modular” can mean a lot of things.

Where it makes the clearest impact is at the intersection of speed, flexibility, and capital efficiency. For an advanced therapy developer who needs GMP-compliant space in 12 months, not 36, modular is often the only viable path. For a company whose process is still evolving, the ability to reconfigure or redeploy a facility is genuinely strategic. And for organizations working across multiple sites or geographies, modular enables a consistency of environment and compliance standard that’s very difficult to achieve with traditional construction.

But I think the underappreciated story is how modular fundamentally derisks the manufacturing investment. Traditional facility builds require enormous capital commitment upfront, often before a therapy has cleared key clinical milestones. If the program fails and in this industry, programs do fail – that capital is largely stranded. Modular changes that equation. You can right-size the investment to the stage of the program, preserve optionality as your science evolves, and in many cases redeploy the infrastructure if priorities shift. For investors and CFOs evaluating where to put capital, that’s not a minor consideration. It’s often the deciding factor.

On the decentralized side, I think we’re at an early but important inflection point. Point-of-care manufacturing for autologous therapies where the product is made close to the patient is a compelling model scientifically, but operationally it’s enormously complex. The facilities, the logistics, the quality systems all have to work in concert. That’s a hard problem, and it’s one where purpose-built modular infrastructure has a real role to play.

What I’d watch over the next several years is the convergence of modular construction with increasingly automated manufacturing processes. As automation matures, the case for decentralized production becomes much stronger – you can maintain quality consistency without the same dependence on highly specialized local labor. That’s where I think the space is heading, and it’s where Germfree is focused.

Read the full interview with Carol Houts at themedicinemaker.com.