North Carolina has become a focal point for the next phase of biopharmaceutical manufacturing, and FUJIFILM Biotechnologies is placing a significant bet on that momentum. Laurie Braxton discusses how the combination of large-scale capacity, experienced talent, and a tightly integrated site network is shaping a long-term manufacturing platform designed for reliability rather than short-term scale. Braxton beyond infrastructure to share insights on leadership, partnership, and the operating discipline required to support complex biologics from development through commercial supply.

 

What shaped your path into manufacturing leadership, and how do the Holly Springs and Research Triangle Park sites fit within your role in North Carolina?

I am Senior Vice President and Head of North Carolina Operations at FUJIFILM Biotechnologies, with responsibility for both the Holly Springs large-scale biologics site and our long-established Research Triangle Park facility. I joined in mid-2024 after more than 22 years at GSK, a move shaped by a long-standing interest in manufacturing strategy and by the ambition behind what we are building in North Carolina.

My career did not begin in manufacturing. I started in procurement and moved into manufacturing through an early role at a respiratory medicines site, where I became drawn to the complexity of turning science into reliable supply. That path led me into external manufacturing and supply, including a period based in the UK leading GSK’s global external manufacturing organisation. Working with partners across more than 40 countries gave me a clear perspective on what good manufacturing looks like, and on how significant the decision to outsource truly is for innovator companies. After returning to the US, I led several GSK manufacturing sites, including a respiratory facility in North Carolina during the early phase of COVID-19 and later a biologics drug substance site in Rockville, Maryland. Those experiences reinforced that manufacturing excellence ultimately rests on people, trust, and leadership, and deepened my interest in biologics, where the technical complexity is matched by the impact these medicines have on patients’ lives.

When FUJIFILM announced its investment in North Carolina, what stood out was not only the scale, but the intent. At Holly Springs, we are building one of the largest end-to-end cell culture biologics manufacturing sites in North America, designed for large-scale drug substance production with integrated drug product capabilities. It is a facility built without compromise, designed to support the industry’s future needs rather than simply meeting today’s demand. My role initially focused on launching Holly Springs, and a few months later expanded to include our Research Triangle Park site in Morrisville. That site has been part of our footprint for more than two decades and operates as a cGMP facility supporting process development and small-scale clinical and commercial manufacturing. Together, the two sites form an integrated network, allowing us to support partners from early development through to commercial scale within a single regional ecosystem, aligned with the same end-to-end model we operate across our sites in the US, Denmark, and the UK.

 

How does the Holly Springs facility fit into FUJIFILM’s broader network, and how is capacity being phased as the site moves toward full operation?

In 2025, we brought the first phase of the Holly Springs site online for cGMP drug substance manufacturing. This initial build comprises two large-scale manufacturing suites, each equipped with four 20,000 litre mammalian cell culture bioreactors, bringing eight bioreactors into operation. Depending on process characteristics and campaign design, each bioreactor can support approximately 17 to 20 batches per year. That initial capacity has already been allocated through long-term partnerships, reflecting strong early demand and confidence in the site as it enters operation.

Subsequent phases will extend Holly Springs into a fully integrated end-to-end manufacturing facility. Later this year, we will add drug product capabilities, including aseptic filling for vials, prefilled syringes, and cartridges, with a high- to medium-speed line capable of producing up to around 30 million doses annually. By 2028, two additional drug substance suites will come online, adding a further eight 20,000 litre bioreactors, followed by additional finished goods capabilities. By completion, the site will span approximately 1.6 million square feet, with expansion deliberately phased to align capacity growth with partner demand while maintaining consistency, quality, and operational discipline.

 

Why did the US, and North Carolina in particular, emerge as the right location for such a significant long-term manufacturing investment? 

At the US level, the decision is closely linked to resilience, proximity, and capability. During the pandemic we saw how vulnerable extended supply chains can be and reinforced the importance of manufacturing closer to the largest patient population and pharmaceutical market. Beyond market size, the depth of manufacturing experience in the US workforce is also a key factor. There is a strong base of technical expertise and operational maturity that supports complex biologics manufacturing at scale, alongside an increasing policy focus on localisation and onshoring that mirrors trends previously seen in other regions.

North Carolina stands out because of the consistency and intent behind how it has built its life sciences ecosystem. When I moved here in the early 2000s, pharmaceutical manufacturing was limited, but the state has since taken a long-term, coordinated approach to attracting industry by investing in infrastructure, education, and partnerships. Proximity to Research Triangle Park was an advantage for us, but more important was the level of alignment we found with state and local authorities, municipalities, and academic institutions, all focused on building something sustainable rather than short term.

A project of this scale depends on more than manufacturing expertise alone. The first phase of Holly Springs required around 14 million construction hours and the involvement of  thousands of skilled trades, alongside early planning for long-term workforce development through collaboration with local universities and training partners. The town of Holly Springs has worked closely with us on infrastructure, capacity, and community integration, helping us move at pace without compromising quality or compliance. That combination of talent, infrastructure, and genuine partnership underpins our confidence in the decision and reflects why North Carolina continues to emerge as a leading hub for biopharmaceutical manufacturing.

 

How do localisation and onshoring policies influence the CDMO sector, particularly in terms of demand, capacity, and collaboration?

From a manufacturing standpoint, the underlying dynamic is driven by unmet patient need rather than by policy alone. Monoclonal antibodies have become foundational therapies across oncology, immunology, infectious diseases, and other areas, and a single molecule can expand into multiple indications as evidence evolves. That reality places sustained pressure on large-scale manufacturing capacity, which continues to lag demand, something we see clearly in how quickly capacity is committed, often well before facilities are fully operational. In that context, localisation is not a headwind for CDMOs, but a reflection of how essential reliable, scalable manufacturing has become.

We do not view increased onshoring or internal manufacturing investments by pharmaceutical companies as competitive threats. Innovators already carry significant scientific and financial risk in developing new therapies, knowing that many programmes will not progress. Our role is to remove manufacturing as a source of uncertainty by acting as a dependable extension of their network, focused on execution, quality, and compliance at scale. Meeting global demand will require a more collaborative model, where capacity is built collectively and deployed intelligently, rather than a fragmented or adversarial approach.

That collaborative mindset is increasingly visible at a regional level. In Holly Springs, multiple major manufacturers now operate side by side, contributing to a rapidly expanding life sciences hub. While competition for talent could easily become a constraint, there has been a shared recognition that long-term success depends on growing the ecosystem as a whole. This has led to coordinated engagement with local colleges and universities on apprenticeships, internships, and curriculum development, helping to build a sustainable talent pipeline. As demand continues to grow, that kind of cooperation will be critical for the CDMO sector and the wider biopharmaceutical industry alike.

 

How are digitalisation, automation, and emerging manufacturing models shaping FUJIFILM’s approach as the CDMO sector evolves?

For us, the starting point is people rather than technology. Earlier in my career, I never expected to join a CDMO, largely because of the perception that the sector focused more on cost than capability. What attracted me to FUJIFILM was the clear intent to position manufacturing as a core contributor to the life sciences ecosystem. At Holly Springs, the majority of our team comes from innovator companies, bringing first-hand experience of what it takes to develop, scale, and supply complex biologics. That depth of experience, combined with the fact that most of the workforce is local, creates a strong sense of ownership and credibility in how we work with partners.

That foundation directly informs how we design our manufacturing model. We operate around a network philosophy known as kojoX, which emphasises consistency, equivalency, and continuous improvement across sites. Holly Springs has been built as a using the “blueprint” of our large-scale biologics facility in Denmark, encompassing facility design, equipment, processes, and procedures. This alignment allows teams to operate seamlessly across the network and enables improvements to be developed and deployed in parallel, building on established performance rather than reinventing approaches site by site.

Digitalisation and automation are embedded into that model from the outset. Holly Springs will start up as a paperless facility, avoiding the complexity of retrofitting legacy systems, and our data architecture is designed to provide customers with real-time visibility into operations. The objective is not technology for its own sake, but transparency, speed, and trust. Supported by teams who have spent years navigating complex process change elsewhere, this approach allows us to simplify and adapt more quickly, using digital tools to reinforce disciplined, high-quality execution at scale.

 

What does FUJIFILM’s partnership philosophy look like in practice, and how is it embedded into the culture and daily operations at Holly Springs?

For me, strong partnerships are built on depth and consistency rather than surface alignment. They depend on understanding how our partners operate, what they prioritise, and how decisions are made when pressure is high, not only when everything is going well. That perspective shapes how we lead our teams and how we engage with customers day to day. Transparency and trust only have value if they are demonstrated through actions, particularly when challenges arise. Having spent much of my career on the innovator side, I am very aware of how difficult it is when issues surface late or decisions happen without shared context. We are deliberate about involving partners early and keeping them closely connected throughout the process, even when conversations are uncomfortable.

That mindset directly informs how we structure partnerships at Holly Springs. Our ambition is to support products from early development through to commercial supply with the same standards, accountability, and way of working at every stage. In practice, this means working alongside our partners on site, involving them in performance discussions, and aligning priorities together rather than operating at a distance. This goes well beyond the traditional notion of a representative simply overseeing operations. Our partners are actively involved in how we plan, execute, and improve, while maintaining the necessary controls around confidentiality and governance.

We see ourselves as an extension of our partners’ manufacturing networks rather than an external supplier. The same philosophy applies to how we engage with the wider ecosystem, including organisations building capacity nearby. The focus is not short-term competition, but long-term trust, shared learning, and dependable execution. What we bring to the table is deep expertise in large-scale biologics manufacturing, delivered consistently and to the highest standards, and that is where we believe lasting partnerships are created.

 

What message would you share with your partners and the broader life sciences community as FUJIFILM continues to grow?

It consistently comes back to three fundamentals. The first is our people. We put real emphasis on creating an environment where individuals feel valued, supported, and able to build a long-term career with us. That focus is not aspirational language. It directly shapes how we operate and underpins our ability to attract and retain partners who value consistency and care in execution. The second is delivery. We are highly disciplined about setting our facilities up for success from the outset and about meeting commitments with reliability, quality, and compliance at the forefront. Trust is built through performance, and that is something we take very seriously.

The third element is agility across our network. Whether the industry frames the discussion around regionalisation, localisation, or globalisation, our operating model is designed to adapt without disruption. By structuring our network around the kojoX philosophy, we have built in the flexibility to support customers wherever they need us, both in the near term and over the long term. Together, these principles define how we operate and how we intend to grow. The coming years will be demanding, but they are also a genuinely exciting period for the industry and for us, and one we are approaching with confidence and purpose.